Spinal Fusion
Conditions
Brief summary
The aim of this investigation is to compare the use of bone marrow aspirate concentrate (BMAC) and allograft versus recombinant human bone morphogenetic protein-2 (BMP) versus the gold standard fusion in subjects undergoing elective lumbar spinal fusion with interbody support. The safety and efficacy of the surgical interventions will be evaluated by assessing fusion status and subjects' quality of life outcomes.
Detailed description
This study will be a prospective, randomized clinical study at a single-center, NYU Langone Medical Center. It is intended to compare and evaluate the efficacy of subjects who are either treated with (1) bone marrow aspirate concentrate (BMAC) and allograft or (2) recombinant human bone morphogenetic protein-2 (BMP) or (3) autograft (control) during lumbar spinal fusion with interbody support. The clinical, radiographic, and Health Related Quality of Life (HRQOL) outcomes will be assessed in operatively treated adult spinal degenerative disease patients undergoing lumbar spinal fusion.
Interventions
DEVICEBone Marrow Aspirate Concentrate (BMAC) + Allograft
Allograft infused with adult stem cells from the bone marrow aspirate harvested from the iliac crest. Harvest BMAC System delivers high stem cell concentration to the graft site.
DEVICERecombinant Human Bone Morphogenetic Protein-2 (BMP)
INFUSE rhBMP-2 Bone Graft used according to its approved FDA labels, both from an anterior approach using titanium cages as well as from a posterior interbody approach using polyetheretherketone (PEEK) cages.
PROCEDUREAutograft
Autograft with bone marrow aspirate.
Sponsors
NYU Langone Health
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Must be 18 years old or older * Scheduled for elective posterior or anterior and posterior spinal fusion of the thoracolumbar spine with or without anterior interbody support * Failed at least 6 weeks of conservative care * No contraindication to BMAC (as per manufacturer) * Signed consent form
Exclusion criteria
* Prior lumbar fusion surgery at operative level (prior discectomy and/or laminectomy allowed) * Incompetent or missing anterior arch at the affected level (e.g. laminectomy, pars defect) * Currently requires laminectomy at level of surgery * Facet joints at implant level are absent or fractured * Post-traumatic vertebral body compromise or acute fracture at implant level * Body mass Index (BMI) \> 40 * Known allergy to titanium * Paget's disease, osteomalacia, or any other metabolic bone disease * Use of medications or any drug known to potentially interfere with bone/soft tissue healing (e.g. chronic systemic steroids) * Unlikely to comply with the follow-up evaluation schedule * Active malignancy defined as history of invasive malignancy, except if the subject has received treatment and displayed no clinical signs and symptoms for at least five years * Pregnant or planning to become pregnant during the length of study participation
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Successful Fusion Status at Month 12 Post-Procedure | Month 12 Post-Operation | Fusion status assessed via CT scan by an independent radiologist. |
| Oswestry Disability Index (ODI) Score at Pre-Op Visit | Pre-Operation Visit (Day 0) | The ODI is a questionnaire used to assess the functional disability caused by low back pain. It consists of 10 questions, each rated on a scale of 0 (none) to 5 (extreme). The scores from the 10 questions are added up to obtain the raw score; the raw score is divided by the maximum possible score (50) and multiplied by 100 to obtain a percentage score, interpreted as follows: 0-20%: Minimal disability, 21-40%: Moderate disability, 41-60%: Severe disability, 61-80%: Crippling disability, and 81-100%: Bedridden or completely disabled. |
| ODI Score at Week 6 Follow-Up | Week 6 Post-Operation | The ODI is a questionnaire used to assess the functional disability caused by low back pain. It consists of 10 questions, each rated on a scale of 0 (none) to 5 (extreme). The scores from the 10 questions are added up to obtain the raw score; the raw score is divided by the maximum possible score (50) and multiplied by 100 to obtain a percentage score, interpreted as follows: 0-20%: Minimal disability, 21-40%: Moderate disability, 41-60%: Severe disability, 61-80%: Crippling disability, and 81-100%: Bedridden or completely disabled. |
| ODI Score at Month 3 Follow-Up | Month 3 Post-Operation | The ODI is a questionnaire used to assess the functional disability caused by low back pain. It consists of 10 questions, each rated on a scale of 0 (none) to 5 (extreme). The scores from the 10 questions are added up to obtain the raw score; the raw score is divided by the maximum possible score (50) and multiplied by 100 to obtain a percentage score, interpreted as follows: 0-20%: Minimal disability, 21-40%: Moderate disability, 41-60%: Severe disability, 61-80%: Crippling disability, and 81-100%: Bedridden or completely disabled. |
| ODI Score at Month 6 Follow-Up | Month 6 Post-Operation | The ODI is a questionnaire used to assess the functional disability caused by low back pain. It consists of 10 questions, each rated on a scale of 0 (none) to 5 (extreme). The scores from the 10 questions are added up to obtain the raw score; the raw score is divided by the maximum possible score (50) and multiplied by 100 to obtain a percentage score, interpreted as follows: 0-20%: Minimal disability, 21-40%: Moderate disability, 41-60%: Severe disability, 61-80%: Crippling disability, and 81-100%: Bedridden or completely disabled. |
| ODI Score at Month 12 Follow-Up | Month 12 Post-Operation | The ODI is a questionnaire used to assess the functional disability caused by low back pain. It consists of 10 questions, each rated on a scale of 0 (none) to 5 (extreme). The scores from the 10 questions are added up to obtain the raw score; the raw score is divided by the maximum possible score (50) and multiplied by 100 to obtain a percentage score, interpreted as follows: 0-20%: Minimal disability, 21-40%: Moderate disability, 41-60%: Severe disability, 61-80%: Crippling disability, and 81-100%: Bedridden or completely disabled. |
| ODI Score at Month 24 Follow-Up | Month 24 Post-Operation | The ODI is a questionnaire used to assess the functional disability caused by low back pain. It consists of 10 questions, each rated on a scale of 0 (none) to 5 (extreme). The scores from the 10 questions are added up to obtain the raw score; the raw score is divided by the maximum possible score (50) and multiplied by 100 to obtain a percentage score, interpreted as follows: 0-20%: Minimal disability, 21-40%: Moderate disability, 41-60%: Severe disability, 61-80%: Crippling disability, and 81-100%: Bedridden or completely disabled. |
| Numeric Rating Scale (NRS) - Back Pain Score at Pre-Op Visit | Pre-Operation Visit (Day 0) | Participants evaluate leg and back pain using a VAS ranging from 0 cm to 10 cm. Lower scores indicate lower levels of pain. |
| NRS - Back Pain Score at Week 6 Follow-Up | Week 6 Post-Operation | Participants evaluate leg and back pain using a VAS ranging from 0 cm to 10 cm. Lower scores indicate lower levels of pain. |
| NRS - Back Pain Score at Month 3 Follow-Up | Month 3 Post-Operation | Participants evaluate leg and back pain using a VAS ranging from 0 cm to 10 cm. Lower scores indicate lower levels of pain. |
| SF-12 - PCS Score at Month 3 Follow-Up | Month 3 Post-Operation | The SF-12 PCS is a physical component summary score from the Short Form 12 (SF-12) health survey. The PCS portion of the survey comprises 6 items; the item scores are standardized to a final t-score. The final score ranges from 0-100 with a mean of 50. Higher scores indicate greater physical quality of life. |
| NRS - Back Pain Score at Month 6 Follow-Up | Month 6 Post-Operation | Participants evaluate leg and back pain using a VAS ranging from 0 cm to 10 cm. Lower scores indicate lower levels of pain. |
| NRS - Back Pain Score at Month 12 Follow-Up | Month 12 Post-Operation | Participants evaluate leg and back pain using a VAS ranging from 0 cm to 10 cm. Lower scores indicate lower levels of pain. |
| NRS - Back Pain Score at Month 24 Follow-Up | Month 24 Post-Operation | Participants evaluate leg and back pain using a VAS ranging from 0 cm to 10 cm. Lower scores indicate lower levels of pain. |
| Short Form 12 (SF-12) - Physical Component Summary (PCS) Score at Pre-Op Visit | Pre-Operation Visit (Day 0) | The SF-12 PCS is a physical component summary score from the Short Form 12 (SF-12) health survey. The PCS portion of the survey comprises 6 items; the item scores are standardized to a final t-score. The final score ranges from 0-100 with a mean of 50. Higher scores indicate greater physical quality of life. |
| SF-12 - PCS Score at Week 6 Follow-Up | Week 6 Post-Operation | The SF-12 PCS is a physical component summary score from the Short Form 12 (SF-12) health survey. The PCS portion of the survey comprises 6 items; the item scores are standardized to a final t-score. The final score ranges from 0-100 with a mean of 50. Higher scores indicate greater physical quality of life. |
| SF-12 - PCS Score at Month 6 Follow-Up | Month 6 Post-Operation | The SF-12 PCS is a physical component summary score from the Short Form 12 (SF-12) health survey. The PCS portion of the survey comprises 6 items; the item scores are standardized to a final t-score. The final score ranges from 0-100 with a mean of 50. Higher scores indicate greater physical quality of life. |
| SF-12 - PCS Score at Month 12 Follow-Up | Month 12 Post-Operation | The SF-12 PCS is a physical component summary score from the Short Form 12 (SF-12) health survey. The PCS portion of the survey comprises 6 items; the item scores are standardized to a final t-score. The final score ranges from 0-100 with a mean of 50. Higher scores indicate greater physical quality of life. |
| SF-12 - PCS Score at Month 24 Follow-Up | Month 24 Post-Operation | The SF-12 PCS is a physical component summary score from the Short Form 12 (SF-12) health survey. The PCS portion of the survey comprises 6 items; the item scores are standardized to a final t-score. The final score ranges from 0-100 with a mean of 50. Higher scores indicate greater physical quality of life. |
| SF-12 - Mental Component Summary (MCS) Score at Pre-Op Visit | Pre-Operation Visit (Day 0) | The SF-12 MCS is a mental component summary score from the Short Form 12 (SF-12) health survey. The MCS portion of the survey comprises 6 items; the item scores are standardized to a final t-score. The final score ranges from 0-100 with a mean of 50. Higher scores indicate greater mental quality of life. |
| SF-12 - MCS Score at Week 6 Follow-Up | Week 6 Post-Operation | The SF-12 MCS is a mental component summary score from the Short Form 12 (SF-12) health survey. The MCS portion of the survey comprises 6 items; the item scores are standardized to a final t-score. The final score ranges from 0-100 with a mean of 50. Higher scores indicate greater mental quality of life. |
| SF-12 - MCS Score at Month 3 Follow-Up | Month 3 Follow-Up Post-Operation | The SF-12 MCS is a mental component summary score from the Short Form 12 (SF-12) health survey. The MCS portion of the survey comprises 6 items; the item scores are standardized to a final t-score. The final score ranges from 0-100 with a mean of 50. Higher scores indicate greater mental quality of life. |
| SF-12 - MCS Score at Month 6 Follow-Up | Month 6 Post-Operation | The SF-12 MCS is a mental component summary score from the Short Form 12 (SF-12) health survey. The MCS portion of the survey comprises 6 items; the item scores are standardized to a final t-score. The final score ranges from 0-100 with a mean of 50. Higher scores indicate greater mental quality of life. |
| Euro-Qol 5-Dimension (EQ-5D) Score at Pre-Op Visit | Pre-Operation Visit (Day 0) | 5-item self-report questionnaire. Each item describes a different aspect of health: Mobility, Self-Care, Usual Activities, Pain/Discomfort, and Anxiety/Depression. Participants rank items on a 3-point Likert scale from 1-3: 1 = no problems; 2 = some problems; 3 = extreme problems. The total score is the sum of responses and ranges from 5-15; lower scores indicate better overall health. |
| EQ-5D Score at Week 6 Follow-Up | Week 6 Post-Operation | 5-item self-report questionnaire. Each item describes a different aspect of health: Mobility, Self-Care, Usual Activities, Pain/Discomfort, and Anxiety/Depression. Participants rank items on a 3-point Likert scale from 1-3: 1 = no problems; 2 = some problems; 3 = extreme problems. The total score is the sum of responses and ranges from 5-15; lower scores indicate better overall health. |
| EQ-5D Score at Month 3 Follow-Up | Month 3 Post-Operation | 5-item self-report questionnaire. Each item describes a different aspect of health: Mobility, Self-Care, Usual Activities, Pain/Discomfort, and Anxiety/Depression. Participants rank items on a 3-point Likert scale from 1-3: 1 = no problems; 2 = some problems; 3 = extreme problems. The total score is the sum of responses and ranges from 5-15; lower scores indicate better overall health. |
| EQ-5D Score at Month 6 Follow-Up | Month 6 Post-Operation | 5-item self-report questionnaire. Each item describes a different aspect of health: Mobility, Self-Care, Usual Activities, Pain/Discomfort, and Anxiety/Depression. Participants rank items on a 3-point Likert scale from 1-3: 1 = no problems; 2 = some problems; 3 = extreme problems. The total score is the sum of responses and ranges from 5-15; lower scores indicate better overall health. |
| EQ-5D Score at Month 12 Follow-Up | Month 12 Post-Operation | 5-item self-report questionnaire. Each item describes a different aspect of health: Mobility, Self-Care, Usual Activities, Pain/Discomfort, and Anxiety/Depression. Participants rank items on a 3-point Likert scale from 1-3: 1 = no problems; 2 = some problems; 3 = extreme problems. The total score is the sum of responses and ranges from 5-15; lower scores indicate better overall health. |
| EQ-5D Score at Month 24 Follow-Up | Month 24 Post-Operation | 5-item self-report questionnaire. Each item describes a different aspect of health: Mobility, Self-Care, Usual Activities, Pain/Discomfort, and Anxiety/Depression. Participants rank items on a 3-point Likert scale from 1-3: 1 = no problems; 2 = some problems; 3 = extreme problems. The total score is the sum of responses and ranges from 5-15; lower scores indicate better overall health. |
| Pain Catastrophizing Scale (PCS) Score at Pre-Op Visit | Pre-Operation Visit (Day 0) | Self-report questionnaire containing 13 items that describe different thoughts and feelings that may be associated with pain. Participants rank each item on a Likert scale from 0 (not at all) to 4 (all the time). Scores range from 0 to 52; lower scores indicate lower levels of catastrophic thinking related to pain. |
| PCS Score at Week 6 Follow-Up | Week 6 Post-Operation | Self-report questionnaire containing 13 items that describe different thoughts and feelings that may be associated with pain. Participants rank each item on a Likert scale from 0 (not at all) to 4 (all the time). Scores range from 0 to 52; lower scores indicate lower levels of catastrophic thinking related to pain. |
| PCS Score at Month 3 Follow-Up | Month 3 Post-Operation | Self-report questionnaire containing 13 items that describe different thoughts and feelings that may be associated with pain. Participants rank each item on a Likert scale from 0 (not at all) to 4 (all the time). Scores range from 0 to 52; lower scores indicate lower levels of catastrophic thinking related to pain. |
| PCS Score at Month 6 Follow-Up | Month 6 Post-Operation | Self-report questionnaire containing 13 items that describe different thoughts and feelings that may be associated with pain. Participants rank each item on a Likert scale from 0 (not at all) to 4 (all the time). Scores range from 0 to 52; lower scores indicate lower levels of catastrophic thinking related to pain. |
| PCS Score at Month 12 Follow-Up | Month 12 Post-Operation | Self-report questionnaire containing 13 items that describe different thoughts and feelings that may be associated with pain. Participants rank each item on a Likert scale from 0 (not at all) to 4 (all the time). Scores range from 0 to 52; lower scores indicate lower levels of catastrophic thinking related to pain. |
| PCS Score at Month 24 Follow-Up | Month 24 Post-Operation | Self-report questionnaire containing 13 items that describe different thoughts and feelings that may be associated with pain. Participants rank each item on a Likert scale from 0 (not at all) to 4 (all the time). Scores range from 0 to 52; lower scores indicate lower levels of catastrophic thinking related to pain. |
| Patient Reported Outcome Measure Information System (PROMIS) Item Bank v1.1 - Pain Interference Score at Pre-Op Visit | Pre-Operation Visit (Day 0) | 40-item self-report assessing the negative effects of pain on functioning in the range experienced by the vast majority of people who have pain. Participants rank items on a 5-point Likert scale ranging from 0 to 4. The raw score is the sum of responses and ranges from 0-160; lower scores indicate lower interference from pain. The raw score is translated to give a T-score for each participant. The T-score rescales the raw score into a standardized score ranging from 0 to 100, with a mean of 50 and a standard deviation (SD) of 10. Higher T-scores indicate greater interference from pain. |
| PROMIS Item Bank v1.1 - Pain Interference Score at Week 6 Follow-Up | Week 6 Post-Operation | 40-item self-report assessing the negative effects of pain on functioning in the range experienced by the vast majority of people who have pain. Participants rank items on a 5-point Likert scale ranging from 0 to 4. The raw score is the sum of responses and ranges from 0-160; lower scores indicate lower interference from pain. The raw score is translated to give a T-score for each participant. The T-score rescales the raw score into a standardized score ranging from 0 to 100, with a mean of 50 and a standard deviation (SD) of 10. Higher T-scores indicate greater interference from pain. |
| PROMIS Item Bank v1.1 - Pain Interference Score at Month 3 Follow-Up | Month 3 Post-Operation | 40-item self-report assessing the negative effects of pain on functioning in the range experienced by the vast majority of people who have pain. Participants rank items on a 5-point Likert scale ranging from 0 to 4. The raw score is the sum of responses and ranges from 0-160; lower scores indicate lower interference from pain. The raw score is translated to give a T-score for each participant. The T-score rescales the raw score into a standardized score ranging from 0 to 100, with a mean of 50 and a standard deviation (SD) of 10. Higher T-scores indicate greater interference from pain. |
| PROMIS Item Bank v1.1 - Pain Interference Score at Month 6 Follow-Up | Month 6 Post-Operation | 40-item self-report assessing the negative effects of pain on functioning in the range experienced by the vast majority of people who have pain. Participants rank items on a 5-point Likert scale ranging from 0 to 4. The raw score is the sum of responses and ranges from 0-160; lower scores indicate lower interference from pain. The raw score is translated to give a T-score for each participant. The T-score rescales the raw score into a standardized score ranging from 0 to 100, with a mean of 50 and a standard deviation (SD) of 10. Higher T-scores indicate greater interference from pain. |
| PROMIS Item Bank v1.1 - Pain Interference Score at Month 12 Follow-Up | Month 12 Post-Operation | 40-item self-report assessing the negative effects of pain on functioning in the range experienced by the vast majority of people who have pain. Participants rank items on a 5-point Likert scale ranging from 0 to 4. The raw score is the sum of responses and ranges from 0-160; lower scores indicate lower interference from pain. The raw score is translated to give a T-score for each participant. The T-score rescales the raw score into a standardized score ranging from 0 to 100, with a mean of 50 and a standard deviation (SD) of 10. Higher T-scores indicate greater interference from pain. |
| PROMIS Item Bank v1.1 - Pain Interference Score at Month 24 Follow-Up | Month 24 Post-Operation | 40-item self-report assessing the negative effects of pain on functioning in the range experienced by the vast majority of people who have pain. Participants rank items on a 5-point Likert scale ranging from 0 to 4. The raw score is the sum of responses and ranges from 0-160; lower scores indicate lower interference from pain. The raw score is translated to give a T-score for each participant. The T-score rescales the raw score into a standardized score ranging from 0 to 100, with a mean of 50 and a standard deviation (SD) of 10. Higher T-scores indicate greater interference from pain. |
| PROMIS Scale v1.0 - Pain Intensity 3a Score at Pre-Op Visit | Pre-Operation Visit (Day 0) | 3-item self-report assessment of how much a participant hurts. Participants rank items on a 5-point Likert scale ranging from 0 (Had no pain) to 4 (Very severe). The raw score is the sum of responses and ranges from 0-12; lower scores indicate lower levels of pain. The raw score is translated to give a T-score for each participant. The T-score rescales the raw score into a standardized score ranging from 0-100, with a mean of 50 and a standard deviation (SD) of 10. Higher T-scores indicate higher intensity of pain. |
| PROMIS Scale v1.0 - Pain Intensity 3a Score at Week 6 Follow-Up | Week 6 Post-Operation | 3-item self-report assessment of how much a participant hurts. Participants rank items on a 5-point Likert scale ranging from 0 (Had no pain) to 4 (Very severe). The raw score is the sum of responses and ranges from 0-12; lower scores indicate lower levels of pain. The raw score is translated to give a T-score for each participant. The T-score rescales the raw score into a standardized score ranging from 0-100, with a mean of 50 and a standard deviation (SD) of 10. Higher T-scores indicate higher intensity of pain. |
| PROMIS Scale v1.0 - Pain Intensity 3a Score at Month 3 Follow-Up | Month 3 Post-Operation | 3-item self-report assessment of how much a participant hurts. Participants rank items on a 5-point Likert scale ranging from 0 (Had no pain) to 4 (Very severe). The raw score is the sum of responses and ranges from 0-12; lower scores indicate lower levels of pain. The raw score is translated to give a T-score for each participant. The T-score rescales the raw score into a standardized score ranging from 0-100, with a mean of 50 and a standard deviation (SD) of 10. Higher T-scores indicate higher intensity of pain. |
| PROMIS Scale v1.0 - Pain Intensity 3a Score at Month 6 Follow-Up | Month 6 Post-Operation | 3-item self-report assessment of how much a participant hurts. Participants rank items on a 5-point Likert scale ranging from 0 (Had no pain) to 4 (Very severe). The raw score is the sum of responses and ranges from 0-12; lower scores indicate lower levels of pain. The raw score is translated to give a T-score for each participant. The T-score rescales the raw score into a standardized score ranging from 0-100, with a mean of 50 and a standard deviation (SD) of 10. Higher T-scores indicate higher intensity of pain. |
| PROMIS Scale v1.0 - Pain Intensity 3a Score at Month 12 Follow-Up | Month 12 Post-Operation | 3-item self-report assessment of how much a participant hurts. Participants rank items on a 5-point Likert scale ranging from 0 (Had no pain) to 4 (Very severe). The raw score is the sum of responses and ranges from 0-12; lower scores indicate lower levels of pain. The raw score is translated to give a T-score for each participant. The T-score rescales the raw score into a standardized score ranging from 0-100, with a mean of 50 and a standard deviation (SD) of 10. Higher T-scores indicate higher intensity of pain. |
| PROMIS Scale v1.0 - Pain Intensity 3a Score at Month 24 Follow-Up | Month 24 Post-Operation | 3-item self-report assessment of how much a participant hurts. Participants rank items on a 5-point Likert scale ranging from 0 (Had no pain) to 4 (Very severe). The raw score is the sum of responses and ranges from 0-12; lower scores indicate lower levels of pain. The raw score is translated to give a T-score for each participant. The T-score rescales the raw score into a standardized score ranging from 0-100, with a mean of 50 and a standard deviation (SD) of 10. Higher T-scores indicate higher intensity of pain. |
| PROMIS Bank v1.2 - Physical Function Score at Pre-Op Visit | Pre-Operation Visit (Day 0) | 120-item self-report assessment of physical health, physical function, pain, and fatigue. Participants rank items on a 5-point Likert scale ranging from 0 to 4. The raw score is the sum of responses and ranges from 0-480; lower scores indicate higher levels of physical function. The raw score is translated to give a T-score for each participant. The T-score rescales the raw score into a standardized score ranging from 0 to 100, with a mean of 50 and a standard deviation (SD) of 10. Higher scores indicate greater physical function. |
| PROMIS Bank v1.2 - Physical Function Score at Week 6 Follow-Up | Week 6 Post-Operation | 120-item self-report assessment of physical health, physical function, pain, and fatigue. Participants rank items on a 5-point Likert scale ranging from 0 to 4. The raw score is the sum of responses and ranges from 0-480; lower scores indicate higher levels of physical function. The raw score is translated to give a T-score for each participant. The T-score rescales the raw score into a standardized score ranging from 0 to 100, with a mean of 50 and a standard deviation (SD) of 10. Higher scores indicate greater physical function. |
| PROMIS Bank v1.2 - Physical Function Score at Month 3 Follow-Up | Month 3 Post-Operation | 120-item self-report assessment of physical health, physical function, pain, and fatigue. Participants rank items on a 5-point Likert scale ranging from 0 to 4. The raw score is the sum of responses and ranges from 0-480; lower scores indicate higher levels of physical function. The raw score is translated to give a T-score for each participant. The T-score rescales the raw score into a standardized score ranging from 0 to 100, with a mean of 50 and a standard deviation (SD) of 10. Higher scores indicate greater physical function. |
| PROMIS Bank v1.2 - Physical Function Score at Month 6 Follow-Up | Month 6 Post-Operation | 120-item self-report assessment of physical health, physical function, pain, and fatigue. Participants rank items on a 5-point Likert scale ranging from 0 to 4. The raw score is the sum of responses and ranges from 0-480; lower scores indicate higher levels of physical function. The raw score is translated to give a T-score for each participant. The T-score rescales the raw score into a standardized score ranging from 0 to 100, with a mean of 50 and a standard deviation (SD) of 10. Higher scores indicate greater physical function. |
| PROMIS Bank v1.2 - Physical Function Score at Month 12 Follow-Up | Month 12 Post-Operation | 120-item self-report assessment of physical health, physical function, pain, and fatigue. Participants rank items on a 5-point Likert scale ranging from 0 to 4. The raw score is the sum of responses and ranges from 0-480; lower scores indicate higher levels of physical function. The raw score is translated to give a T-score for each participant. The T-score rescales the raw score into a standardized score ranging from 0 to 100, with a mean of 50 and a standard deviation (SD) of 10. Higher scores indicate greater physical function. |
| PROMIS Bank v1.2 - Physical Function Score at Month 24 Follow-Up | Month 24 Post-Operation | 120-item self-report assessment of physical health, physical function, pain, and fatigue. Participants rank items on a 5-point Likert scale ranging from 0 to 4. The raw score is the sum of responses and ranges from 0-480; lower scores indicate higher levels of physical function. The raw score is translated to give a T-score for each participant. The T-score rescales the raw score into a standardized score ranging from 0 to 100, with a mean of 50 and a standard deviation (SD) of 10. Higher scores indicate greater physical function. |
| PROMIS Bank v2.0 - Mobility Score at Pre-Op Visit | Pre-Operation Visit (Day 0) | 15-item self-report assessment of activities of physical mobility. Each item is ranked on a 5-point Likert scale ranging from 0 to 4. The raw score is the sum of responses and ranges from 0-60; lower scores indicate higher levels of physical mobility. The raw score is translated to give a T-score for each participant. The T-score rescales the raw score into a standardized score ranging from 0-100, with a mean of 50 and a standard deviation (SD) of 10. Higher T-scores indicate greater physical mobility. |
| PROMIS Bank v2.0 - Mobility Score at Week 6 Follow-Up | Week 6 Post-Operation | 15-item self-report assessment of activities of physical mobility. Each item is ranked on a 5-point Likert scale ranging from 0 to 4. The raw score is the sum of responses and ranges from 0-60; lower scores indicate higher levels of physical mobility. The raw score is translated to give a T-score for each participant. The T-score rescales the raw score into a standardized score ranging from 0-100, with a mean of 50 and a standard deviation (SD) of 10. Higher T-scores indicate greater physical mobility. |
| PROMIS Bank v2.0 - Mobility Score at Month 3 Follow-Up | Month 3 Post-Operation | 15-item self-report assessment of activities of physical mobility. Each item is ranked on a 5-point Likert scale ranging from 0 to 4. The raw score is the sum of responses and ranges from 0-60; lower scores indicate higher levels of physical mobility. The raw score is translated to give a T-score for each participant. The T-score rescales the raw score into a standardized score ranging from 0-100, with a mean of 50 and a standard deviation (SD) of 10. Higher T-scores indicate greater physical mobility. |
| PROMIS Bank v2.0 - Mobility Score at Month 6 Follow-Up | Month 6 Post-Operation | 15-item self-report assessment of activities of physical mobility. Each item is ranked on a 5-point Likert scale ranging from 0 to 4. The raw score is the sum of responses and ranges from 0-60; lower scores indicate higher levels of physical mobility. The raw score is translated to give a T-score for each participant. The T-score rescales the raw score into a standardized score ranging from 0-100, with a mean of 50 and a standard deviation (SD) of 10. Higher T-scores indicate greater physical mobility. |
| PROMIS Bank v2.0 - Mobility Score at Month 12 Follow-Up | Month 12 Post-Operation | 15-item self-report assessment of activities of physical mobility. Each item is ranked on a 5-point Likert scale ranging from 0 to 4. The raw score is the sum of responses and ranges from 0-60; lower scores indicate higher levels of physical mobility. The raw score is translated to give a T-score for each participant. The T-score rescales the raw score into a standardized score ranging from 0-100, with a mean of 50 and a standard deviation (SD) of 10. Higher T-scores indicate greater physical mobility. |
| PROMIS Bank v2.0 - Mobility Score at Month 24 Follow-Up | Month 24 Post-Operation | 15-item self-report assessment of activities of physical mobility. Each item is ranked on a 5-point Likert scale ranging from 0 to 4. The raw score is the sum of responses and ranges from 0-60; lower scores indicate higher levels of physical mobility. The raw score is translated to give a T-score for each participant. The T-score rescales the raw score into a standardized score ranging from 0-100, with a mean of 50 and a standard deviation (SD) of 10. Higher T-scores indicate greater physical mobility. |
| Length of Operation | Intraoperative Period (Day 0) (typically between 2-7 hours) | — |
| Length of Hospital Stay | From admission up to discharge (Up to Year 2 Post-Operation) | — |
| Blood Loss During Procedure | Intraoperative Period (Day 0) (typically between 2-7 hours) | — |
| Number of Participants Using Non-Prescription, Over-the-Counter (OTC) Drugs at Pre-Op Visit | Pre-Operation Visit (Day 0) | Number of participants taking OTC drugs for pain relief. |
| Number of Participants Using Non-Prescription, OTC Drugs at Week 6 Follow-Up | Week 6 Post-Operation | Number of participants taking OTC drugs for pain relief. |
| Number of Participants Using Non-Prescription, OTC Drugs at Month 3 Follow-Up | Month 3 Post-Operation | Number of participants taking OTC drugs for pain relief. |
| Number of Participants Using Non-Prescription, OTC Drugs at Month 6 Follow-Up | Month 6 Post-Operation | Number of participants taking OTC drugs for pain relief. |
| Number of Participants Using Non-Prescription, OTC Drugs at Month 12 Follow-Up | Month 12 Post-Operation | Number of participants taking OTC drugs for pain relief. |
| Number of Participants Using Non-Prescription, OTC Drugs at Month 24 Follow-Up | Month 24 Post-Operation | Number of participants taking OTC drugs for pain relief. |
| Number of Participants With Surgical Complications During Operation | Intraoperative Period (Day 0) (typically between 2-7 hours) | — |
| Number of Participants With Surgical Complications at Week 6 Follow-Up | Week 6 Post-Operation | — |
| Number of Participants With Surgical Complications at Month 3 Follow-Up | Month 3 Post-Operation | — |
| Number of Participants With Surgical Complications at Month 6 Follow-Up | Month 6 Post-Operation | — |
| Number of Participants With Surgical Complications at Month 12 Follow-Up | Month 12 Post-Operation | — |
| Number of Participants With Surgical Complications at Month 24 Follow-Up | Month 24 Post-Operation | — |
| SF-12 - MCS Score at Month 12 Follow-Up | Month 12 Post-Operation | The SF-12 MCS is a mental component summary score from the Short Form 12 (SF-12) health survey. The MCS portion of the survey comprises 6 items; the item scores are standardized to a final t-score. The final score ranges from 0-100 with a mean of 50. Higher scores indicate greater mental quality of life. |
| SF-12 - MCS Score at Month 24 Follow-Up | Month 12 Post-Operation | The SF-12 MCS is a mental component summary score from the Short Form 12 (SF-12) health survey. The MCS portion of the survey comprises 6 items; the item scores are standardized to a final t-score. The final score ranges from 0-100 with a mean of 50. Higher scores indicate greater mental quality of life. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Bone Marrow Aspirate Concentrate (BMAC) + Allograft A total of 60, 120, or 180 mL of BMA to be aspirated. BMA is then placed into the Harvest SmartPrep® Bone Marrow Concentrate (BMAC) system and concentrated to a final volume of 10, 20, or 30 mL. The BMAC will then be combined with packed allograft cancellous bone chips using the Harvest Graft Delivery Pack. The allograft bone will be obtained routinely from the bone bank in the operating suite.
If using Harvest Graft Delivery Kit, the BMAC dosing estimate is as follows (BMAC to graft ratio will be 1:1):
* 1-level fusion: 10 cc of BMAC from 60 cc of BMA (roughly 10 cc of graft)
* 2-level fusion: 20 cc of BMAC from 120 cc of BMA
* 3-level fusion: 20 cc of BMAC from 120 cc of BMA
* 4-level fusion: 180 cc kit
* 5-level fusion: 240 cc kit
If not using Harvest Graft Delivery Kit:
* Volume of BMAC will be slightly increased (some BMAC will not get directly into hydrating the graft as the BMAC would get lost in the hydration process and left in mixing bowls).
Bone Marrow Aspirate Concentrate (BMAC) + Allograft: Allograft infused with adult stem cells from the bone marrow aspirate harvested from the iliac crest. Harvest BMAC System delivers high stem cell concentration to the graft site. | 20 |
| Recombinant Human Bone Morphogenetic Protein-2 (BMP) 12 mL BMP will be applied at the surgical site of the interbody fusion using a collagen sponge following manufacturer's directions.
The BMP kit use per level is as follows:
* 1 Level Fusion: Extra small kit (1.4 cc)
* 2 Level Fusion: Small Kit (2.8cc)
* 3 Level Fusion: (4.2 cc)
* 4 Level Fusion: Medium Kit (5.6cc)
* 5 Level Fusion: (7.0 cc)
Recombinant Human Bone Morphogenetic Protein-2 (BMP): INFUSE rhBMP-2 Bone Graft used according to its approved FDA labels, both from an anterior approach using titanium cages as well as from a posterior interbody approach using polyetheretherketone (PEEK) cages. | 20 |
| Autograft As per standard of care, the control group will receive 15cc - 45 cc of allograft with autograft and bone marrow aspirate at each level. The iliac crest is the common donor site for autograft. Using the standard technique for anterior lateral fusion, the bone graft will be laid onto the desired site of fusion.
Autograft: Autograft with bone marrow aspirate. | 19 |
| Total | 59 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Lost to Follow-up | 1 | 1 | 0 |
Baseline characteristics
| Characteristic | Bone Marrow Aspirate Concentrate (BMAC) + Allograft | Total | Autograft | Recombinant Human Bone Morphogenetic Protein-2 (BMP) |
|---|---|---|---|---|
| Age, Continuous | 58.1 years STANDARD_DEVIATION 12.9 | 56.53 years STANDARD_DEVIATION 13.57 | 55.9 years STANDARD_DEVIATION 13.6 | 55.6 years STANDARD_DEVIATION 14.2 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 4 Participants | 14 Participants | 5 Participants | 5 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 13 Participants | 36 Participants | 10 Participants | 13 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 3 Participants | 9 Participants | 4 Participants | 2 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 4 Participants | 1 Participants | 2 Participants |
| Race (NIH/OMB) Black or African American | 5 Participants | 16 Participants | 4 Participants | 7 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 2 Participants | 5 Participants | 2 Participants | 1 Participants |
| Race (NIH/OMB) White | 12 Participants | 34 Participants | 12 Participants | 10 Participants |
| Region of Enrollment United States | 20 participants | 59 participants | 19 participants | 20 participants |
| Sex: Female, Male Female | 12 Participants | 35 Participants | 10 Participants | 13 Participants |
| Sex: Female, Male Male | 8 Participants | 24 Participants | 9 Participants | 7 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 20 | 0 / 20 | 0 / 19 |
| other Total, other adverse events | 4 / 20 | 6 / 20 | 4 / 19 |
| serious Total, serious adverse events | 0 / 20 | 0 / 20 | 0 / 19 |
Outcome results
Primary
Blood Loss During Procedure
Time frame: Intraoperative Period (Day 0) (typically between 2-7 hours)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Bone Marrow Aspirate Concentrate (BMAC) + Allograft | Blood Loss During Procedure | 845.3 Millilitres | Standard Deviation 316.7 |
| Recombinant Human Bone Morphogenetic Protein-2 (BMP) | Blood Loss During Procedure | 866.1 Millilitres | Standard Deviation 286.4 |
| Autograft | Blood Loss During Procedure | 833.6 Millilitres | Standard Deviation 322.7 |
Primary
EQ-5D Score at Month 12 Follow-Up
5-item self-report questionnaire. Each item describes a different aspect of health: Mobility, Self-Care, Usual Activities, Pain/Discomfort, and Anxiety/Depression. Participants rank items on a 3-point Likert scale from 1-3: 1 = no problems; 2 = some problems; 3 = extreme problems. The total score is the sum of responses and ranges from 5-15; lower scores indicate better overall health.
Time frame: Month 12 Post-Operation
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Bone Marrow Aspirate Concentrate (BMAC) + Allograft | EQ-5D Score at Month 12 Follow-Up | 6.9 score on a scale | Standard Deviation 1.1 |
| Recombinant Human Bone Morphogenetic Protein-2 (BMP) | EQ-5D Score at Month 12 Follow-Up | 7 score on a scale | Standard Deviation 1.7 |
| Autograft | EQ-5D Score at Month 12 Follow-Up | 7.4 score on a scale | Standard Deviation 2 |
Primary
EQ-5D Score at Month 24 Follow-Up
5-item self-report questionnaire. Each item describes a different aspect of health: Mobility, Self-Care, Usual Activities, Pain/Discomfort, and Anxiety/Depression. Participants rank items on a 3-point Likert scale from 1-3: 1 = no problems; 2 = some problems; 3 = extreme problems. The total score is the sum of responses and ranges from 5-15; lower scores indicate better overall health.
Time frame: Month 24 Post-Operation
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Bone Marrow Aspirate Concentrate (BMAC) + Allograft | EQ-5D Score at Month 24 Follow-Up | 7.1 score on a scale | Standard Deviation 1 |
| Recombinant Human Bone Morphogenetic Protein-2 (BMP) | EQ-5D Score at Month 24 Follow-Up | 7.4 score on a scale | Standard Deviation 1.7 |
| Autograft | EQ-5D Score at Month 24 Follow-Up | 7 score on a scale | Standard Deviation 1.6 |
Primary
EQ-5D Score at Month 3 Follow-Up
5-item self-report questionnaire. Each item describes a different aspect of health: Mobility, Self-Care, Usual Activities, Pain/Discomfort, and Anxiety/Depression. Participants rank items on a 3-point Likert scale from 1-3: 1 = no problems; 2 = some problems; 3 = extreme problems. The total score is the sum of responses and ranges from 5-15; lower scores indicate better overall health.
Time frame: Month 3 Post-Operation
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Bone Marrow Aspirate Concentrate (BMAC) + Allograft | EQ-5D Score at Month 3 Follow-Up | 8 score on a scale | Standard Deviation 2.5 |
| Recombinant Human Bone Morphogenetic Protein-2 (BMP) | EQ-5D Score at Month 3 Follow-Up | 7.9 score on a scale | Standard Deviation 1.3 |
| Autograft | EQ-5D Score at Month 3 Follow-Up | 8.3 score on a scale | Standard Deviation 1.7 |
Primary
EQ-5D Score at Month 6 Follow-Up
5-item self-report questionnaire. Each item describes a different aspect of health: Mobility, Self-Care, Usual Activities, Pain/Discomfort, and Anxiety/Depression. Participants rank items on a 3-point Likert scale from 1-3: 1 = no problems; 2 = some problems; 3 = extreme problems. The total score is the sum of responses and ranges from 5-15; lower scores indicate better overall health.
Time frame: Month 6 Post-Operation
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Bone Marrow Aspirate Concentrate (BMAC) + Allograft | EQ-5D Score at Month 6 Follow-Up | 7.6 score on a scale | Standard Deviation 1.6 |
| Recombinant Human Bone Morphogenetic Protein-2 (BMP) | EQ-5D Score at Month 6 Follow-Up | 7.1 score on a scale | Standard Deviation 1.1 |
| Autograft | EQ-5D Score at Month 6 Follow-Up | 7.8 score on a scale | Standard Deviation 1.3 |
Primary
EQ-5D Score at Week 6 Follow-Up
5-item self-report questionnaire. Each item describes a different aspect of health: Mobility, Self-Care, Usual Activities, Pain/Discomfort, and Anxiety/Depression. Participants rank items on a 3-point Likert scale from 1-3: 1 = no problems; 2 = some problems; 3 = extreme problems. The total score is the sum of responses and ranges from 5-15; lower scores indicate better overall health.
Time frame: Week 6 Post-Operation
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Bone Marrow Aspirate Concentrate (BMAC) + Allograft | EQ-5D Score at Week 6 Follow-Up | 8.4 score on a scale | Standard Deviation 1.3 |
| Recombinant Human Bone Morphogenetic Protein-2 (BMP) | EQ-5D Score at Week 6 Follow-Up | 8.1 score on a scale | Standard Deviation 0.7 |
| Autograft | EQ-5D Score at Week 6 Follow-Up | 9 score on a scale | Standard Deviation 1.8 |
Primary
Euro-Qol 5-Dimension (EQ-5D) Score at Pre-Op Visit
5-item self-report questionnaire. Each item describes a different aspect of health: Mobility, Self-Care, Usual Activities, Pain/Discomfort, and Anxiety/Depression. Participants rank items on a 3-point Likert scale from 1-3: 1 = no problems; 2 = some problems; 3 = extreme problems. The total score is the sum of responses and ranges from 5-15; lower scores indicate better overall health.
Time frame: Pre-Operation Visit (Day 0)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Bone Marrow Aspirate Concentrate (BMAC) + Allograft | Euro-Qol 5-Dimension (EQ-5D) Score at Pre-Op Visit | 10 score on a scale | Standard Deviation 1.1 |
| Recombinant Human Bone Morphogenetic Protein-2 (BMP) | Euro-Qol 5-Dimension (EQ-5D) Score at Pre-Op Visit | 11 score on a scale | Standard Deviation 1.3 |
| Autograft | Euro-Qol 5-Dimension (EQ-5D) Score at Pre-Op Visit | 10.5 score on a scale | Standard Deviation 0.5 |
Primary
Length of Hospital Stay
Time frame: From admission up to discharge (Up to Year 2 Post-Operation)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Bone Marrow Aspirate Concentrate (BMAC) + Allograft | Length of Hospital Stay | 7.1 Days | Standard Deviation 4.1 |
| Recombinant Human Bone Morphogenetic Protein-2 (BMP) | Length of Hospital Stay | 8 Days | Standard Deviation 4.4 |
| Autograft | Length of Hospital Stay | 7.3 Days | Standard Deviation 3.8 |
Primary
Length of Operation
Time frame: Intraoperative Period (Day 0) (typically between 2-7 hours)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Bone Marrow Aspirate Concentrate (BMAC) + Allograft | Length of Operation | 324.6 minutes | Standard Deviation 114.8 |
| Recombinant Human Bone Morphogenetic Protein-2 (BMP) | Length of Operation | 354.4 minutes | Standard Deviation 125.3 |
| Autograft | Length of Operation | 315.7 minutes | Standard Deviation 133.8 |
Primary
NRS - Back Pain Score at Month 12 Follow-Up
Participants evaluate leg and back pain using a VAS ranging from 0 cm to 10 cm. Lower scores indicate lower levels of pain.
Time frame: Month 12 Post-Operation
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Bone Marrow Aspirate Concentrate (BMAC) + Allograft | NRS - Back Pain Score at Month 12 Follow-Up | 4.2 score on a scale | Standard Deviation 1.4 |
| Recombinant Human Bone Morphogenetic Protein-2 (BMP) | NRS - Back Pain Score at Month 12 Follow-Up | 4.6 score on a scale | Standard Deviation 1.7 |
| Autograft | NRS - Back Pain Score at Month 12 Follow-Up | 4.4 score on a scale | Standard Deviation 1.2 |
Primary
NRS - Back Pain Score at Month 24 Follow-Up
Participants evaluate leg and back pain using a VAS ranging from 0 cm to 10 cm. Lower scores indicate lower levels of pain.
Time frame: Month 24 Post-Operation
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Bone Marrow Aspirate Concentrate (BMAC) + Allograft | NRS - Back Pain Score at Month 24 Follow-Up | 4 score on a scale | Standard Deviation 1.1 |
| Recombinant Human Bone Morphogenetic Protein-2 (BMP) | NRS - Back Pain Score at Month 24 Follow-Up | 4.1 score on a scale | Standard Deviation 0.5 |
| Autograft | NRS - Back Pain Score at Month 24 Follow-Up | 4.1 score on a scale | Standard Deviation 0.9 |
Primary
NRS - Back Pain Score at Month 3 Follow-Up
Participants evaluate leg and back pain using a VAS ranging from 0 cm to 10 cm. Lower scores indicate lower levels of pain.
Time frame: Month 3 Post-Operation
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Bone Marrow Aspirate Concentrate (BMAC) + Allograft | NRS - Back Pain Score at Month 3 Follow-Up | 4.8 score on a scale | Standard Deviation 1.1 |
| Recombinant Human Bone Morphogenetic Protein-2 (BMP) | NRS - Back Pain Score at Month 3 Follow-Up | 5.2 score on a scale | Standard Deviation 1.3 |
| Autograft | NRS - Back Pain Score at Month 3 Follow-Up | 4.7 score on a scale | Standard Deviation 1.6 |
Primary
NRS - Back Pain Score at Month 6 Follow-Up
Participants evaluate leg and back pain using a VAS ranging from 0 cm to 10 cm. Lower scores indicate lower levels of pain.
Time frame: Month 6 Post-Operation
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Bone Marrow Aspirate Concentrate (BMAC) + Allograft | NRS - Back Pain Score at Month 6 Follow-Up | 4.7 score on a scale | Standard Deviation 1.3 |
| Recombinant Human Bone Morphogenetic Protein-2 (BMP) | NRS - Back Pain Score at Month 6 Follow-Up | 5 score on a scale | Standard Deviation 1.4 |
| Autograft | NRS - Back Pain Score at Month 6 Follow-Up | 4.7 score on a scale | Standard Deviation 1 |
Primary
NRS - Back Pain Score at Week 6 Follow-Up
Participants evaluate leg and back pain using a VAS ranging from 0 cm to 10 cm. Lower scores indicate lower levels of pain.
Time frame: Week 6 Post-Operation
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Bone Marrow Aspirate Concentrate (BMAC) + Allograft | NRS - Back Pain Score at Week 6 Follow-Up | 5.3 score on a scale | Standard Deviation 1.6 |
| Recombinant Human Bone Morphogenetic Protein-2 (BMP) | NRS - Back Pain Score at Week 6 Follow-Up | 5.6 score on a scale | Standard Deviation 2.1 |
| Autograft | NRS - Back Pain Score at Week 6 Follow-Up | 4.9 score on a scale | Standard Deviation 1.9 |
Primary
Number of Participants Using Non-Prescription, OTC Drugs at Month 12 Follow-Up
Number of participants taking OTC drugs for pain relief.
Time frame: Month 12 Post-Operation
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Bone Marrow Aspirate Concentrate (BMAC) + Allograft | Number of Participants Using Non-Prescription, OTC Drugs at Month 12 Follow-Up | 9 Participants |
| Recombinant Human Bone Morphogenetic Protein-2 (BMP) | Number of Participants Using Non-Prescription, OTC Drugs at Month 12 Follow-Up | 11 Participants |
| Autograft | Number of Participants Using Non-Prescription, OTC Drugs at Month 12 Follow-Up | 12 Participants |
Primary
Number of Participants Using Non-Prescription, OTC Drugs at Month 24 Follow-Up
Number of participants taking OTC drugs for pain relief.
Time frame: Month 24 Post-Operation
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Bone Marrow Aspirate Concentrate (BMAC) + Allograft | Number of Participants Using Non-Prescription, OTC Drugs at Month 24 Follow-Up | 6 Participants |
| Recombinant Human Bone Morphogenetic Protein-2 (BMP) | Number of Participants Using Non-Prescription, OTC Drugs at Month 24 Follow-Up | 8 Participants |
| Autograft | Number of Participants Using Non-Prescription, OTC Drugs at Month 24 Follow-Up | 8 Participants |
Primary
Number of Participants Using Non-Prescription, OTC Drugs at Month 3 Follow-Up
Number of participants taking OTC drugs for pain relief.
Time frame: Month 3 Post-Operation
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Bone Marrow Aspirate Concentrate (BMAC) + Allograft | Number of Participants Using Non-Prescription, OTC Drugs at Month 3 Follow-Up | 17 Participants |
| Recombinant Human Bone Morphogenetic Protein-2 (BMP) | Number of Participants Using Non-Prescription, OTC Drugs at Month 3 Follow-Up | 18 Participants |
| Autograft | Number of Participants Using Non-Prescription, OTC Drugs at Month 3 Follow-Up | 18 Participants |
Primary
Number of Participants Using Non-Prescription, OTC Drugs at Month 6 Follow-Up
Number of participants taking OTC drugs for pain relief.
Time frame: Month 6 Post-Operation
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Bone Marrow Aspirate Concentrate (BMAC) + Allograft | Number of Participants Using Non-Prescription, OTC Drugs at Month 6 Follow-Up | 10 Participants |
| Recombinant Human Bone Morphogenetic Protein-2 (BMP) | Number of Participants Using Non-Prescription, OTC Drugs at Month 6 Follow-Up | 12 Participants |
| Autograft | Number of Participants Using Non-Prescription, OTC Drugs at Month 6 Follow-Up | 15 Participants |
Primary
Number of Participants Using Non-Prescription, OTC Drugs at Week 6 Follow-Up
Number of participants taking OTC drugs for pain relief.
Time frame: Week 6 Post-Operation
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Bone Marrow Aspirate Concentrate (BMAC) + Allograft | Number of Participants Using Non-Prescription, OTC Drugs at Week 6 Follow-Up | 20 Participants |
| Recombinant Human Bone Morphogenetic Protein-2 (BMP) | Number of Participants Using Non-Prescription, OTC Drugs at Week 6 Follow-Up | 20 Participants |
| Autograft | Number of Participants Using Non-Prescription, OTC Drugs at Week 6 Follow-Up | 19 Participants |
Primary
Number of Participants Using Non-Prescription, Over-the-Counter (OTC) Drugs at Pre-Op Visit
Number of participants taking OTC drugs for pain relief.
Time frame: Pre-Operation Visit (Day 0)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Bone Marrow Aspirate Concentrate (BMAC) + Allograft | Number of Participants Using Non-Prescription, Over-the-Counter (OTC) Drugs at Pre-Op Visit | 20 Participants |
| Recombinant Human Bone Morphogenetic Protein-2 (BMP) | Number of Participants Using Non-Prescription, Over-the-Counter (OTC) Drugs at Pre-Op Visit | 20 Participants |
| Autograft | Number of Participants Using Non-Prescription, Over-the-Counter (OTC) Drugs at Pre-Op Visit | 19 Participants |
Primary
Number of Participants With Successful Fusion Status at Month 12 Post-Procedure
Fusion status assessed via CT scan by an independent radiologist.
Time frame: Month 12 Post-Operation
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Bone Marrow Aspirate Concentrate (BMAC) + Allograft | Number of Participants With Successful Fusion Status at Month 12 Post-Procedure | 17 Participants |
| Recombinant Human Bone Morphogenetic Protein-2 (BMP) | Number of Participants With Successful Fusion Status at Month 12 Post-Procedure | 16 Participants |
| Autograft | Number of Participants With Successful Fusion Status at Month 12 Post-Procedure | 16 Participants |
Primary
Number of Participants With Surgical Complications at Month 12 Follow-Up
Time frame: Month 12 Post-Operation
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Bone Marrow Aspirate Concentrate (BMAC) + Allograft | Number of Participants With Surgical Complications at Month 12 Follow-Up | 3 Participants |
| Recombinant Human Bone Morphogenetic Protein-2 (BMP) | Number of Participants With Surgical Complications at Month 12 Follow-Up | 4 Participants |
| Autograft | Number of Participants With Surgical Complications at Month 12 Follow-Up | 3 Participants |
Primary
Number of Participants With Surgical Complications at Month 24 Follow-Up
Time frame: Month 24 Post-Operation
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Bone Marrow Aspirate Concentrate (BMAC) + Allograft | Number of Participants With Surgical Complications at Month 24 Follow-Up | 3 Participants |
| Recombinant Human Bone Morphogenetic Protein-2 (BMP) | Number of Participants With Surgical Complications at Month 24 Follow-Up | 4 Participants |
| Autograft | Number of Participants With Surgical Complications at Month 24 Follow-Up | 3 Participants |
Primary
Number of Participants With Surgical Complications at Month 3 Follow-Up
Time frame: Month 3 Post-Operation
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Bone Marrow Aspirate Concentrate (BMAC) + Allograft | Number of Participants With Surgical Complications at Month 3 Follow-Up | 0 Participants |
| Recombinant Human Bone Morphogenetic Protein-2 (BMP) | Number of Participants With Surgical Complications at Month 3 Follow-Up | 0 Participants |
| Autograft | Number of Participants With Surgical Complications at Month 3 Follow-Up | 0 Participants |
Primary
Number of Participants With Surgical Complications at Month 6 Follow-Up
Time frame: Month 6 Post-Operation
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Bone Marrow Aspirate Concentrate (BMAC) + Allograft | Number of Participants With Surgical Complications at Month 6 Follow-Up | 0 Participants |
| Recombinant Human Bone Morphogenetic Protein-2 (BMP) | Number of Participants With Surgical Complications at Month 6 Follow-Up | 0 Participants |
| Autograft | Number of Participants With Surgical Complications at Month 6 Follow-Up | 0 Participants |
Primary
Number of Participants With Surgical Complications at Week 6 Follow-Up
Time frame: Week 6 Post-Operation
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Bone Marrow Aspirate Concentrate (BMAC) + Allograft | Number of Participants With Surgical Complications at Week 6 Follow-Up | 0 Participants |
| Recombinant Human Bone Morphogenetic Protein-2 (BMP) | Number of Participants With Surgical Complications at Week 6 Follow-Up | 0 Participants |
| Autograft | Number of Participants With Surgical Complications at Week 6 Follow-Up | 0 Participants |
Primary
Number of Participants With Surgical Complications During Operation
Time frame: Intraoperative Period (Day 0) (typically between 2-7 hours)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Bone Marrow Aspirate Concentrate (BMAC) + Allograft | Number of Participants With Surgical Complications During Operation | 0 Participants |
| Recombinant Human Bone Morphogenetic Protein-2 (BMP) | Number of Participants With Surgical Complications During Operation | 0 Participants |
| Autograft | Number of Participants With Surgical Complications During Operation | 0 Participants |
Primary
Numeric Rating Scale (NRS) - Back Pain Score at Pre-Op Visit
Participants evaluate leg and back pain using a VAS ranging from 0 cm to 10 cm. Lower scores indicate lower levels of pain.
Time frame: Pre-Operation Visit (Day 0)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Bone Marrow Aspirate Concentrate (BMAC) + Allograft | Numeric Rating Scale (NRS) - Back Pain Score at Pre-Op Visit | 8.1 score on a scale | Standard Deviation 0.8 |
| Recombinant Human Bone Morphogenetic Protein-2 (BMP) | Numeric Rating Scale (NRS) - Back Pain Score at Pre-Op Visit | 7.6 score on a scale | Standard Deviation 0.2 |
| Autograft | Numeric Rating Scale (NRS) - Back Pain Score at Pre-Op Visit | 8.2 score on a scale | Standard Deviation 0.3 |
Primary
ODI Score at Month 12 Follow-Up
The ODI is a questionnaire used to assess the functional disability caused by low back pain. It consists of 10 questions, each rated on a scale of 0 (none) to 5 (extreme). The scores from the 10 questions are added up to obtain the raw score; the raw score is divided by the maximum possible score (50) and multiplied by 100 to obtain a percentage score, interpreted as follows: 0-20%: Minimal disability, 21-40%: Moderate disability, 41-60%: Severe disability, 61-80%: Crippling disability, and 81-100%: Bedridden or completely disabled.
Time frame: Month 12 Post-Operation
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Bone Marrow Aspirate Concentrate (BMAC) + Allograft | ODI Score at Month 12 Follow-Up | 34.2 Percentage score | Standard Deviation 2.2 |
| Recombinant Human Bone Morphogenetic Protein-2 (BMP) | ODI Score at Month 12 Follow-Up | 36.5 Percentage score | Standard Deviation 2.9 |
| Autograft | ODI Score at Month 12 Follow-Up | 36.8 Percentage score | Standard Deviation 2.4 |
Primary
ODI Score at Month 24 Follow-Up
The ODI is a questionnaire used to assess the functional disability caused by low back pain. It consists of 10 questions, each rated on a scale of 0 (none) to 5 (extreme). The scores from the 10 questions are added up to obtain the raw score; the raw score is divided by the maximum possible score (50) and multiplied by 100 to obtain a percentage score, interpreted as follows: 0-20%: Minimal disability, 21-40%: Moderate disability, 41-60%: Severe disability, 61-80%: Crippling disability, and 81-100%: Bedridden or completely disabled.
Time frame: Month 24 Post-Operation
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Bone Marrow Aspirate Concentrate (BMAC) + Allograft | ODI Score at Month 24 Follow-Up | 28.6 Percentage score | Standard Deviation 2.4 |
| Recombinant Human Bone Morphogenetic Protein-2 (BMP) | ODI Score at Month 24 Follow-Up | 30.5 Percentage score | Standard Deviation 5.1 |
| Autograft | ODI Score at Month 24 Follow-Up | 30.9 Percentage score | Standard Deviation 3.6 |
Primary
ODI Score at Month 3 Follow-Up
The ODI is a questionnaire used to assess the functional disability caused by low back pain. It consists of 10 questions, each rated on a scale of 0 (none) to 5 (extreme). The scores from the 10 questions are added up to obtain the raw score; the raw score is divided by the maximum possible score (50) and multiplied by 100 to obtain a percentage score, interpreted as follows: 0-20%: Minimal disability, 21-40%: Moderate disability, 41-60%: Severe disability, 61-80%: Crippling disability, and 81-100%: Bedridden or completely disabled.
Time frame: Month 3 Post-Operation
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Bone Marrow Aspirate Concentrate (BMAC) + Allograft | ODI Score at Month 3 Follow-Up | 41.1 Percentage score | Standard Deviation 4 |
| Recombinant Human Bone Morphogenetic Protein-2 (BMP) | ODI Score at Month 3 Follow-Up | 40.6 Percentage score | Standard Deviation 2.5 |
| Autograft | ODI Score at Month 3 Follow-Up | 41.8 Percentage score | Standard Deviation 2.9 |
Primary
ODI Score at Month 6 Follow-Up
The ODI is a questionnaire used to assess the functional disability caused by low back pain. It consists of 10 questions, each rated on a scale of 0 (none) to 5 (extreme). The scores from the 10 questions are added up to obtain the raw score; the raw score is divided by the maximum possible score (50) and multiplied by 100 to obtain a percentage score, interpreted as follows: 0-20%: Minimal disability, 21-40%: Moderate disability, 41-60%: Severe disability, 61-80%: Crippling disability, and 81-100%: Bedridden or completely disabled.
Time frame: Month 6 Post-Operation
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Bone Marrow Aspirate Concentrate (BMAC) + Allograft | ODI Score at Month 6 Follow-Up | 38.2 Percentage score | Standard Deviation 3.4 |
| Recombinant Human Bone Morphogenetic Protein-2 (BMP) | ODI Score at Month 6 Follow-Up | 40.3 Percentage score | Standard Deviation 1.6 |
| Autograft | ODI Score at Month 6 Follow-Up | 40.5 Percentage score | Standard Deviation 2.1 |
Primary
ODI Score at Week 6 Follow-Up
The ODI is a questionnaire used to assess the functional disability caused by low back pain. It consists of 10 questions, each rated on a scale of 0 (none) to 5 (extreme). The scores from the 10 questions are added up to obtain the raw score; the raw score is divided by the maximum possible score (50) and multiplied by 100 to obtain a percentage score, interpreted as follows: 0-20%: Minimal disability, 21-40%: Moderate disability, 41-60%: Severe disability, 61-80%: Crippling disability, and 81-100%: Bedridden or completely disabled.
Time frame: Week 6 Post-Operation
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Bone Marrow Aspirate Concentrate (BMAC) + Allograft | ODI Score at Week 6 Follow-Up | 43.5 Percentage score | Standard Deviation 3.8 |
| Recombinant Human Bone Morphogenetic Protein-2 (BMP) | ODI Score at Week 6 Follow-Up | 40.2 Percentage score | Standard Deviation 5.2 |
| Autograft | ODI Score at Week 6 Follow-Up | 44.6 Percentage score | Standard Deviation 5.1 |
Primary
Oswestry Disability Index (ODI) Score at Pre-Op Visit
The ODI is a questionnaire used to assess the functional disability caused by low back pain. It consists of 10 questions, each rated on a scale of 0 (none) to 5 (extreme). The scores from the 10 questions are added up to obtain the raw score; the raw score is divided by the maximum possible score (50) and multiplied by 100 to obtain a percentage score, interpreted as follows: 0-20%: Minimal disability, 21-40%: Moderate disability, 41-60%: Severe disability, 61-80%: Crippling disability, and 81-100%: Bedridden or completely disabled.
Time frame: Pre-Operation Visit (Day 0)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Bone Marrow Aspirate Concentrate (BMAC) + Allograft | Oswestry Disability Index (ODI) Score at Pre-Op Visit | 64.8 Percentage score | Standard Deviation 4.2 |
| Recombinant Human Bone Morphogenetic Protein-2 (BMP) | Oswestry Disability Index (ODI) Score at Pre-Op Visit | 66.1 Percentage score | Standard Deviation 2.5 |
| Autograft | Oswestry Disability Index (ODI) Score at Pre-Op Visit | 60.2 Percentage score | Standard Deviation 2.6 |
Primary
Pain Catastrophizing Scale (PCS) Score at Pre-Op Visit
Self-report questionnaire containing 13 items that describe different thoughts and feelings that may be associated with pain. Participants rank each item on a Likert scale from 0 (not at all) to 4 (all the time). Scores range from 0 to 52; lower scores indicate lower levels of catastrophic thinking related to pain.
Time frame: Pre-Operation Visit (Day 0)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Bone Marrow Aspirate Concentrate (BMAC) + Allograft | Pain Catastrophizing Scale (PCS) Score at Pre-Op Visit | 33.6 score on a scale | Standard Deviation 2.4 |
| Recombinant Human Bone Morphogenetic Protein-2 (BMP) | Pain Catastrophizing Scale (PCS) Score at Pre-Op Visit | 35.2 score on a scale | Standard Deviation 1.9 |
| Autograft | Pain Catastrophizing Scale (PCS) Score at Pre-Op Visit | 35.4 score on a scale | Standard Deviation 2.8 |
Primary
Patient Reported Outcome Measure Information System (PROMIS) Item Bank v1.1 - Pain Interference Score at Pre-Op Visit
40-item self-report assessing the negative effects of pain on functioning in the range experienced by the vast majority of people who have pain. Participants rank items on a 5-point Likert scale ranging from 0 to 4. The raw score is the sum of responses and ranges from 0-160; lower scores indicate lower interference from pain. The raw score is translated to give a T-score for each participant. The T-score rescales the raw score into a standardized score ranging from 0 to 100, with a mean of 50 and a standard deviation (SD) of 10. Higher T-scores indicate greater interference from pain.
Time frame: Pre-Operation Visit (Day 0)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Bone Marrow Aspirate Concentrate (BMAC) + Allograft | Patient Reported Outcome Measure Information System (PROMIS) Item Bank v1.1 - Pain Interference Score at Pre-Op Visit | 63.2 T-score | Standard Deviation 3.5 |
| Recombinant Human Bone Morphogenetic Protein-2 (BMP) | Patient Reported Outcome Measure Information System (PROMIS) Item Bank v1.1 - Pain Interference Score at Pre-Op Visit | 65.1 T-score | Standard Deviation 3.8 |
| Autograft | Patient Reported Outcome Measure Information System (PROMIS) Item Bank v1.1 - Pain Interference Score at Pre-Op Visit | 60.2 T-score | Standard Deviation 2.8 |
Primary
PCS Score at Month 12 Follow-Up
Self-report questionnaire containing 13 items that describe different thoughts and feelings that may be associated with pain. Participants rank each item on a Likert scale from 0 (not at all) to 4 (all the time). Scores range from 0 to 52; lower scores indicate lower levels of catastrophic thinking related to pain.
Time frame: Month 12 Post-Operation
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Bone Marrow Aspirate Concentrate (BMAC) + Allograft | PCS Score at Month 12 Follow-Up | 17.3 score on a scale | Standard Deviation 2.4 |
| Recombinant Human Bone Morphogenetic Protein-2 (BMP) | PCS Score at Month 12 Follow-Up | 19.8 score on a scale | Standard Deviation 2.9 |
| Autograft | PCS Score at Month 12 Follow-Up | 20.1 score on a scale | Standard Deviation 2.1 |
Primary
PCS Score at Month 24 Follow-Up
Self-report questionnaire containing 13 items that describe different thoughts and feelings that may be associated with pain. Participants rank each item on a Likert scale from 0 (not at all) to 4 (all the time). Scores range from 0 to 52; lower scores indicate lower levels of catastrophic thinking related to pain.
Time frame: Month 24 Post-Operation
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Bone Marrow Aspirate Concentrate (BMAC) + Allograft | PCS Score at Month 24 Follow-Up | 11.3 score on a scale | Standard Deviation 2.4 |
| Recombinant Human Bone Morphogenetic Protein-2 (BMP) | PCS Score at Month 24 Follow-Up | 14.3 score on a scale | Standard Deviation 2.8 |
| Autograft | PCS Score at Month 24 Follow-Up | 15.1 score on a scale | Standard Deviation 3.1 |
Primary
PCS Score at Month 3 Follow-Up
Self-report questionnaire containing 13 items that describe different thoughts and feelings that may be associated with pain. Participants rank each item on a Likert scale from 0 (not at all) to 4 (all the time). Scores range from 0 to 52; lower scores indicate lower levels of catastrophic thinking related to pain.
Time frame: Month 3 Post-Operation
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Bone Marrow Aspirate Concentrate (BMAC) + Allograft | PCS Score at Month 3 Follow-Up | 21.5 score on a scale | Standard Deviation 2.9 |
| Recombinant Human Bone Morphogenetic Protein-2 (BMP) | PCS Score at Month 3 Follow-Up | 25.8 score on a scale | Standard Deviation 3.4 |
| Autograft | PCS Score at Month 3 Follow-Up | 25.2 score on a scale | Standard Deviation 2.5 |
Primary
PCS Score at Month 6 Follow-Up
Self-report questionnaire containing 13 items that describe different thoughts and feelings that may be associated with pain. Participants rank each item on a Likert scale from 0 (not at all) to 4 (all the time). Scores range from 0 to 52; lower scores indicate lower levels of catastrophic thinking related to pain.
Time frame: Month 6 Post-Operation
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Bone Marrow Aspirate Concentrate (BMAC) + Allograft | PCS Score at Month 6 Follow-Up | 20.6 score on a scale | Standard Deviation 3.6 |
| Recombinant Human Bone Morphogenetic Protein-2 (BMP) | PCS Score at Month 6 Follow-Up | 22.2 score on a scale | Standard Deviation 3.1 |
| Autograft | PCS Score at Month 6 Follow-Up | 20.4 score on a scale | Standard Deviation 2.6 |
Primary
PCS Score at Week 6 Follow-Up
Self-report questionnaire containing 13 items that describe different thoughts and feelings that may be associated with pain. Participants rank each item on a Likert scale from 0 (not at all) to 4 (all the time). Scores range from 0 to 52; lower scores indicate lower levels of catastrophic thinking related to pain.
Time frame: Week 6 Post-Operation
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Bone Marrow Aspirate Concentrate (BMAC) + Allograft | PCS Score at Week 6 Follow-Up | 30.4 score on a scale | Standard Deviation 1.8 |
| Recombinant Human Bone Morphogenetic Protein-2 (BMP) | PCS Score at Week 6 Follow-Up | 29.6 score on a scale | Standard Deviation 2.6 |
| Autograft | PCS Score at Week 6 Follow-Up | 31.1 score on a scale | Standard Deviation 2.4 |
Primary
PROMIS Bank v1.2 - Physical Function Score at Month 12 Follow-Up
120-item self-report assessment of physical health, physical function, pain, and fatigue. Participants rank items on a 5-point Likert scale ranging from 0 to 4. The raw score is the sum of responses and ranges from 0-480; lower scores indicate higher levels of physical function. The raw score is translated to give a T-score for each participant. The T-score rescales the raw score into a standardized score ranging from 0 to 100, with a mean of 50 and a standard deviation (SD) of 10. Higher scores indicate greater physical function.
Time frame: Month 12 Post-Operation
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Bone Marrow Aspirate Concentrate (BMAC) + Allograft | PROMIS Bank v1.2 - Physical Function Score at Month 12 Follow-Up | 39.7 T-score | Standard Deviation 1.9 |
| Recombinant Human Bone Morphogenetic Protein-2 (BMP) | PROMIS Bank v1.2 - Physical Function Score at Month 12 Follow-Up | 42.4 T-score | Standard Deviation 1.5 |
| Autograft | PROMIS Bank v1.2 - Physical Function Score at Month 12 Follow-Up | 40 T-score | Standard Deviation 1.1 |
Primary
PROMIS Bank v1.2 - Physical Function Score at Month 24 Follow-Up
120-item self-report assessment of physical health, physical function, pain, and fatigue. Participants rank items on a 5-point Likert scale ranging from 0 to 4. The raw score is the sum of responses and ranges from 0-480; lower scores indicate higher levels of physical function. The raw score is translated to give a T-score for each participant. The T-score rescales the raw score into a standardized score ranging from 0 to 100, with a mean of 50 and a standard deviation (SD) of 10. Higher scores indicate greater physical function.
Time frame: Month 24 Post-Operation
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Bone Marrow Aspirate Concentrate (BMAC) + Allograft | PROMIS Bank v1.2 - Physical Function Score at Month 24 Follow-Up | 34.1 T-score | Standard Deviation 2.3 |
| Recombinant Human Bone Morphogenetic Protein-2 (BMP) | PROMIS Bank v1.2 - Physical Function Score at Month 24 Follow-Up | 37.3 T-score | Standard Deviation 2.6 |
| Autograft | PROMIS Bank v1.2 - Physical Function Score at Month 24 Follow-Up | 38 T-score | Standard Deviation 2 |
Primary
PROMIS Bank v1.2 - Physical Function Score at Month 3 Follow-Up
120-item self-report assessment of physical health, physical function, pain, and fatigue. Participants rank items on a 5-point Likert scale ranging from 0 to 4. The raw score is the sum of responses and ranges from 0-480; lower scores indicate higher levels of physical function. The raw score is translated to give a T-score for each participant. The T-score rescales the raw score into a standardized score ranging from 0 to 100, with a mean of 50 and a standard deviation (SD) of 10. Higher scores indicate greater physical function.
Time frame: Month 3 Post-Operation
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Bone Marrow Aspirate Concentrate (BMAC) + Allograft | PROMIS Bank v1.2 - Physical Function Score at Month 3 Follow-Up | 48.3 T-score | Standard Deviation 2.9 |
| Recombinant Human Bone Morphogenetic Protein-2 (BMP) | PROMIS Bank v1.2 - Physical Function Score at Month 3 Follow-Up | 47.7 T-score | Standard Deviation 3.2 |
| Autograft | PROMIS Bank v1.2 - Physical Function Score at Month 3 Follow-Up | 46.5 T-score | Standard Deviation 2.6 |
Primary
PROMIS Bank v1.2 - Physical Function Score at Month 6 Follow-Up
120-item self-report assessment of physical health, physical function, pain, and fatigue. Participants rank items on a 5-point Likert scale ranging from 0 to 4. The raw score is the sum of responses and ranges from 0-480; lower scores indicate higher levels of physical function. The raw score is translated to give a T-score for each participant. The T-score rescales the raw score into a standardized score ranging from 0 to 100, with a mean of 50 and a standard deviation (SD) of 10. Higher scores indicate greater physical function.
Time frame: Month 6 Post-Operation
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Bone Marrow Aspirate Concentrate (BMAC) + Allograft | PROMIS Bank v1.2 - Physical Function Score at Month 6 Follow-Up | 43.6 T-score | Standard Deviation 2.4 |
| Recombinant Human Bone Morphogenetic Protein-2 (BMP) | PROMIS Bank v1.2 - Physical Function Score at Month 6 Follow-Up | 44.9 T-score | Standard Deviation 1.8 |
| Autograft | PROMIS Bank v1.2 - Physical Function Score at Month 6 Follow-Up | 42.2 T-score | Standard Deviation 1.7 |
Primary
PROMIS Bank v1.2 - Physical Function Score at Pre-Op Visit
120-item self-report assessment of physical health, physical function, pain, and fatigue. Participants rank items on a 5-point Likert scale ranging from 0 to 4. The raw score is the sum of responses and ranges from 0-480; lower scores indicate higher levels of physical function. The raw score is translated to give a T-score for each participant. The T-score rescales the raw score into a standardized score ranging from 0 to 100, with a mean of 50 and a standard deviation (SD) of 10. Higher scores indicate greater physical function.
Time frame: Pre-Operation Visit (Day 0)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Bone Marrow Aspirate Concentrate (BMAC) + Allograft | PROMIS Bank v1.2 - Physical Function Score at Pre-Op Visit | 58.9 T-score | Standard Deviation 2.1 |
| Recombinant Human Bone Morphogenetic Protein-2 (BMP) | PROMIS Bank v1.2 - Physical Function Score at Pre-Op Visit | 60.3 T-score | Standard Deviation 3.5 |
| Autograft | PROMIS Bank v1.2 - Physical Function Score at Pre-Op Visit | 54.3 T-score | Standard Deviation 3.1 |
Primary
PROMIS Bank v1.2 - Physical Function Score at Week 6 Follow-Up
120-item self-report assessment of physical health, physical function, pain, and fatigue. Participants rank items on a 5-point Likert scale ranging from 0 to 4. The raw score is the sum of responses and ranges from 0-480; lower scores indicate higher levels of physical function. The raw score is translated to give a T-score for each participant. The T-score rescales the raw score into a standardized score ranging from 0 to 100, with a mean of 50 and a standard deviation (SD) of 10. Higher scores indicate greater physical function.
Time frame: Week 6 Post-Operation
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Bone Marrow Aspirate Concentrate (BMAC) + Allograft | PROMIS Bank v1.2 - Physical Function Score at Week 6 Follow-Up | 50.1 T-score | Standard Deviation 2.5 |
| Recombinant Human Bone Morphogenetic Protein-2 (BMP) | PROMIS Bank v1.2 - Physical Function Score at Week 6 Follow-Up | 52.6 T-score | Standard Deviation 1.8 |
| Autograft | PROMIS Bank v1.2 - Physical Function Score at Week 6 Follow-Up | 51.1 T-score | Standard Deviation 1.6 |
Primary
PROMIS Bank v2.0 - Mobility Score at Month 12 Follow-Up
15-item self-report assessment of activities of physical mobility. Each item is ranked on a 5-point Likert scale ranging from 0 to 4. The raw score is the sum of responses and ranges from 0-60; lower scores indicate higher levels of physical mobility. The raw score is translated to give a T-score for each participant. The T-score rescales the raw score into a standardized score ranging from 0-100, with a mean of 50 and a standard deviation (SD) of 10. Higher T-scores indicate greater physical mobility.
Time frame: Month 12 Post-Operation
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Bone Marrow Aspirate Concentrate (BMAC) + Allograft | PROMIS Bank v2.0 - Mobility Score at Month 12 Follow-Up | 42.7 T-score | Standard Deviation 2.1 |
| Recombinant Human Bone Morphogenetic Protein-2 (BMP) | PROMIS Bank v2.0 - Mobility Score at Month 12 Follow-Up | 44 T-score | Standard Deviation 3.6 |
| Autograft | PROMIS Bank v2.0 - Mobility Score at Month 12 Follow-Up | 44.8 T-score | Standard Deviation 2.5 |
Primary
PROMIS Bank v2.0 - Mobility Score at Month 24 Follow-Up
15-item self-report assessment of activities of physical mobility. Each item is ranked on a 5-point Likert scale ranging from 0 to 4. The raw score is the sum of responses and ranges from 0-60; lower scores indicate higher levels of physical mobility. The raw score is translated to give a T-score for each participant. The T-score rescales the raw score into a standardized score ranging from 0-100, with a mean of 50 and a standard deviation (SD) of 10. Higher T-scores indicate greater physical mobility.
Time frame: Month 24 Post-Operation
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Bone Marrow Aspirate Concentrate (BMAC) + Allograft | PROMIS Bank v2.0 - Mobility Score at Month 24 Follow-Up | 39.5 T-score | Standard Deviation 2.8 |
| Recombinant Human Bone Morphogenetic Protein-2 (BMP) | PROMIS Bank v2.0 - Mobility Score at Month 24 Follow-Up | 41.1 T-score | Standard Deviation 2.4 |
| Autograft | PROMIS Bank v2.0 - Mobility Score at Month 24 Follow-Up | 43 T-score | Standard Deviation 2.7 |
Primary
PROMIS Bank v2.0 - Mobility Score at Month 3 Follow-Up
15-item self-report assessment of activities of physical mobility. Each item is ranked on a 5-point Likert scale ranging from 0 to 4. The raw score is the sum of responses and ranges from 0-60; lower scores indicate higher levels of physical mobility. The raw score is translated to give a T-score for each participant. The T-score rescales the raw score into a standardized score ranging from 0-100, with a mean of 50 and a standard deviation (SD) of 10. Higher T-scores indicate greater physical mobility.
Time frame: Month 3 Post-Operation
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Bone Marrow Aspirate Concentrate (BMAC) + Allograft | PROMIS Bank v2.0 - Mobility Score at Month 3 Follow-Up | 49.8 T-score | Standard Deviation 2.6 |
| Recombinant Human Bone Morphogenetic Protein-2 (BMP) | PROMIS Bank v2.0 - Mobility Score at Month 3 Follow-Up | 51.1 T-score | Standard Deviation 2.4 |
| Autograft | PROMIS Bank v2.0 - Mobility Score at Month 3 Follow-Up | 53 T-score | Standard Deviation 2.3 |
Primary
PROMIS Bank v2.0 - Mobility Score at Month 6 Follow-Up
15-item self-report assessment of activities of physical mobility. Each item is ranked on a 5-point Likert scale ranging from 0 to 4. The raw score is the sum of responses and ranges from 0-60; lower scores indicate higher levels of physical mobility. The raw score is translated to give a T-score for each participant. The T-score rescales the raw score into a standardized score ranging from 0-100, with a mean of 50 and a standard deviation (SD) of 10. Higher T-scores indicate greater physical mobility.
Time frame: Month 6 Post-Operation
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Bone Marrow Aspirate Concentrate (BMAC) + Allograft | PROMIS Bank v2.0 - Mobility Score at Month 6 Follow-Up | 47.2 T-score | Standard Deviation 2.4 |
| Recombinant Human Bone Morphogenetic Protein-2 (BMP) | PROMIS Bank v2.0 - Mobility Score at Month 6 Follow-Up | 49.3 T-score | Standard Deviation 2.8 |
| Autograft | PROMIS Bank v2.0 - Mobility Score at Month 6 Follow-Up | 49.8 T-score | Standard Deviation 2.7 |
Primary
PROMIS Bank v2.0 - Mobility Score at Pre-Op Visit
15-item self-report assessment of activities of physical mobility. Each item is ranked on a 5-point Likert scale ranging from 0 to 4. The raw score is the sum of responses and ranges from 0-60; lower scores indicate higher levels of physical mobility. The raw score is translated to give a T-score for each participant. The T-score rescales the raw score into a standardized score ranging from 0-100, with a mean of 50 and a standard deviation (SD) of 10. Higher T-scores indicate greater physical mobility.
Time frame: Pre-Operation Visit (Day 0)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Bone Marrow Aspirate Concentrate (BMAC) + Allograft | PROMIS Bank v2.0 - Mobility Score at Pre-Op Visit | 62.1 T-score | Standard Deviation 2.8 |
| Recombinant Human Bone Morphogenetic Protein-2 (BMP) | PROMIS Bank v2.0 - Mobility Score at Pre-Op Visit | 60.7 T-score | Standard Deviation 3.5 |
| Autograft | PROMIS Bank v2.0 - Mobility Score at Pre-Op Visit | 64.3 T-score | Standard Deviation 3.2 |
Primary
PROMIS Bank v2.0 - Mobility Score at Week 6 Follow-Up
15-item self-report assessment of activities of physical mobility. Each item is ranked on a 5-point Likert scale ranging from 0 to 4. The raw score is the sum of responses and ranges from 0-60; lower scores indicate higher levels of physical mobility. The raw score is translated to give a T-score for each participant. The T-score rescales the raw score into a standardized score ranging from 0-100, with a mean of 50 and a standard deviation (SD) of 10. Higher T-scores indicate greater physical mobility.
Time frame: Week 6 Post-Operation
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Bone Marrow Aspirate Concentrate (BMAC) + Allograft | PROMIS Bank v2.0 - Mobility Score at Week 6 Follow-Up | 53.6 T-score | Standard Deviation 3.5 |
| Recombinant Human Bone Morphogenetic Protein-2 (BMP) | PROMIS Bank v2.0 - Mobility Score at Week 6 Follow-Up | 55 T-score | Standard Deviation 2.8 |
| Autograft | PROMIS Bank v2.0 - Mobility Score at Week 6 Follow-Up | 56.7 T-score | Standard Deviation 2.7 |
Primary
PROMIS Item Bank v1.1 - Pain Interference Score at Month 12 Follow-Up
40-item self-report assessing the negative effects of pain on functioning in the range experienced by the vast majority of people who have pain. Participants rank items on a 5-point Likert scale ranging from 0 to 4. The raw score is the sum of responses and ranges from 0-160; lower scores indicate lower interference from pain. The raw score is translated to give a T-score for each participant. The T-score rescales the raw score into a standardized score ranging from 0 to 100, with a mean of 50 and a standard deviation (SD) of 10. Higher T-scores indicate greater interference from pain.
Time frame: Month 12 Post-Operation
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Bone Marrow Aspirate Concentrate (BMAC) + Allograft | PROMIS Item Bank v1.1 - Pain Interference Score at Month 12 Follow-Up | 41.3 T-score | Standard Deviation 2.8 |
| Recombinant Human Bone Morphogenetic Protein-2 (BMP) | PROMIS Item Bank v1.1 - Pain Interference Score at Month 12 Follow-Up | 43.7 T-score | Standard Deviation 2.5 |
| Autograft | PROMIS Item Bank v1.1 - Pain Interference Score at Month 12 Follow-Up | 43.5 T-score | Standard Deviation 2.1 |
Primary
PROMIS Item Bank v1.1 - Pain Interference Score at Month 24 Follow-Up
40-item self-report assessing the negative effects of pain on functioning in the range experienced by the vast majority of people who have pain. Participants rank items on a 5-point Likert scale ranging from 0 to 4. The raw score is the sum of responses and ranges from 0-160; lower scores indicate lower interference from pain. The raw score is translated to give a T-score for each participant. The T-score rescales the raw score into a standardized score ranging from 0 to 100, with a mean of 50 and a standard deviation (SD) of 10. Higher T-scores indicate greater interference from pain.
Time frame: Month 24 Post-Operation
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Bone Marrow Aspirate Concentrate (BMAC) + Allograft | PROMIS Item Bank v1.1 - Pain Interference Score at Month 24 Follow-Up | 33.8 T-score | Standard Deviation 2.4 |
| Recombinant Human Bone Morphogenetic Protein-2 (BMP) | PROMIS Item Bank v1.1 - Pain Interference Score at Month 24 Follow-Up | 32.9 T-score | Standard Deviation 2.9 |
| Autograft | PROMIS Item Bank v1.1 - Pain Interference Score at Month 24 Follow-Up | 35.4 T-score | Standard Deviation 2.1 |
Primary
PROMIS Item Bank v1.1 - Pain Interference Score at Month 3 Follow-Up
40-item self-report assessing the negative effects of pain on functioning in the range experienced by the vast majority of people who have pain. Participants rank items on a 5-point Likert scale ranging from 0 to 4. The raw score is the sum of responses and ranges from 0-160; lower scores indicate lower interference from pain. The raw score is translated to give a T-score for each participant. The T-score rescales the raw score into a standardized score ranging from 0 to 100, with a mean of 50 and a standard deviation (SD) of 10. Higher T-scores indicate greater interference from pain.
Time frame: Month 3 Post-Operation
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Bone Marrow Aspirate Concentrate (BMAC) + Allograft | PROMIS Item Bank v1.1 - Pain Interference Score at Month 3 Follow-Up | 50.8 T-score | Standard Deviation 3.7 |
| Recombinant Human Bone Morphogenetic Protein-2 (BMP) | PROMIS Item Bank v1.1 - Pain Interference Score at Month 3 Follow-Up | 49.7 T-score | Standard Deviation 2.5 |
| Autograft | PROMIS Item Bank v1.1 - Pain Interference Score at Month 3 Follow-Up | 51.4 T-score | Standard Deviation 2.1 |
Primary
PROMIS Item Bank v1.1 - Pain Interference Score at Month 6 Follow-Up
40-item self-report assessing the negative effects of pain on functioning in the range experienced by the vast majority of people who have pain. Participants rank items on a 5-point Likert scale ranging from 0 to 4. The raw score is the sum of responses and ranges from 0-160; lower scores indicate lower interference from pain. The raw score is translated to give a T-score for each participant. The T-score rescales the raw score into a standardized score ranging from 0 to 100, with a mean of 50 and a standard deviation (SD) of 10. Higher T-scores indicate greater interference from pain.
Time frame: Month 6 Post-Operation
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Bone Marrow Aspirate Concentrate (BMAC) + Allograft | PROMIS Item Bank v1.1 - Pain Interference Score at Month 6 Follow-Up | 47.4 T-score | Standard Deviation 2.4 |
| Recombinant Human Bone Morphogenetic Protein-2 (BMP) | PROMIS Item Bank v1.1 - Pain Interference Score at Month 6 Follow-Up | 47.6 T-score | Standard Deviation 3.1 |
| Autograft | PROMIS Item Bank v1.1 - Pain Interference Score at Month 6 Follow-Up | 49.3 T-score | Standard Deviation 2.8 |
Primary
PROMIS Item Bank v1.1 - Pain Interference Score at Week 6 Follow-Up
40-item self-report assessing the negative effects of pain on functioning in the range experienced by the vast majority of people who have pain. Participants rank items on a 5-point Likert scale ranging from 0 to 4. The raw score is the sum of responses and ranges from 0-160; lower scores indicate lower interference from pain. The raw score is translated to give a T-score for each participant. The T-score rescales the raw score into a standardized score ranging from 0 to 100, with a mean of 50 and a standard deviation (SD) of 10. Higher T-scores indicate greater interference from pain.
Time frame: Week 6 Post-Operation
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Bone Marrow Aspirate Concentrate (BMAC) + Allograft | PROMIS Item Bank v1.1 - Pain Interference Score at Week 6 Follow-Up | 54.3 T-score | Standard Deviation 2.7 |
| Recombinant Human Bone Morphogenetic Protein-2 (BMP) | PROMIS Item Bank v1.1 - Pain Interference Score at Week 6 Follow-Up | 51.1 T-score | Standard Deviation 2.4 |
| Autograft | PROMIS Item Bank v1.1 - Pain Interference Score at Week 6 Follow-Up | 55.5 T-score | Standard Deviation 3.3 |
Primary
PROMIS Scale v1.0 - Pain Intensity 3a Score at Month 12 Follow-Up
3-item self-report assessment of how much a participant hurts. Participants rank items on a 5-point Likert scale ranging from 0 (Had no pain) to 4 (Very severe). The raw score is the sum of responses and ranges from 0-12; lower scores indicate lower levels of pain. The raw score is translated to give a T-score for each participant. The T-score rescales the raw score into a standardized score ranging from 0-100, with a mean of 50 and a standard deviation (SD) of 10. Higher T-scores indicate higher intensity of pain.
Time frame: Month 12 Post-Operation
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Bone Marrow Aspirate Concentrate (BMAC) + Allograft | PROMIS Scale v1.0 - Pain Intensity 3a Score at Month 12 Follow-Up | 33.2 T-score | Standard Deviation 1.9 |
| Recombinant Human Bone Morphogenetic Protein-2 (BMP) | PROMIS Scale v1.0 - Pain Intensity 3a Score at Month 12 Follow-Up | 35.5 T-score | Standard Deviation 1.5 |
| Autograft | PROMIS Scale v1.0 - Pain Intensity 3a Score at Month 12 Follow-Up | 38.6 T-score | Standard Deviation 2.3 |
Primary
PROMIS Scale v1.0 - Pain Intensity 3a Score at Month 24 Follow-Up
3-item self-report assessment of how much a participant hurts. Participants rank items on a 5-point Likert scale ranging from 0 (Had no pain) to 4 (Very severe). The raw score is the sum of responses and ranges from 0-12; lower scores indicate lower levels of pain. The raw score is translated to give a T-score for each participant. The T-score rescales the raw score into a standardized score ranging from 0-100, with a mean of 50 and a standard deviation (SD) of 10. Higher T-scores indicate higher intensity of pain.
Time frame: Month 24 Post-Operation
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Bone Marrow Aspirate Concentrate (BMAC) + Allograft | PROMIS Scale v1.0 - Pain Intensity 3a Score at Month 24 Follow-Up | 25.3 T-score | Standard Deviation 2.4 |
| Recombinant Human Bone Morphogenetic Protein-2 (BMP) | PROMIS Scale v1.0 - Pain Intensity 3a Score at Month 24 Follow-Up | 20.1 T-score | Standard Deviation 2.8 |
| Autograft | PROMIS Scale v1.0 - Pain Intensity 3a Score at Month 24 Follow-Up | 23.4 T-score | Standard Deviation 3.1 |
Primary
PROMIS Scale v1.0 - Pain Intensity 3a Score at Month 3 Follow-Up
3-item self-report assessment of how much a participant hurts. Participants rank items on a 5-point Likert scale ranging from 0 (Had no pain) to 4 (Very severe). The raw score is the sum of responses and ranges from 0-12; lower scores indicate lower levels of pain. The raw score is translated to give a T-score for each participant. The T-score rescales the raw score into a standardized score ranging from 0-100, with a mean of 50 and a standard deviation (SD) of 10. Higher T-scores indicate higher intensity of pain.
Time frame: Month 3 Post-Operation
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Bone Marrow Aspirate Concentrate (BMAC) + Allograft | PROMIS Scale v1.0 - Pain Intensity 3a Score at Month 3 Follow-Up | 52.8 T-score | Standard Deviation 2.7 |
| Recombinant Human Bone Morphogenetic Protein-2 (BMP) | PROMIS Scale v1.0 - Pain Intensity 3a Score at Month 3 Follow-Up | 51.9 T-score | Standard Deviation 2.9 |
| Autograft | PROMIS Scale v1.0 - Pain Intensity 3a Score at Month 3 Follow-Up | 54.2 T-score | Standard Deviation 3.2 |
Primary
PROMIS Scale v1.0 - Pain Intensity 3a Score at Month 6 Follow-Up
3-item self-report assessment of how much a participant hurts. Participants rank items on a 5-point Likert scale ranging from 0 (Had no pain) to 4 (Very severe). The raw score is the sum of responses and ranges from 0-12; lower scores indicate lower levels of pain. The raw score is translated to give a T-score for each participant. The T-score rescales the raw score into a standardized score ranging from 0-100, with a mean of 50 and a standard deviation (SD) of 10. Higher T-scores indicate higher intensity of pain.
Time frame: Month 6 Post-Operation
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Bone Marrow Aspirate Concentrate (BMAC) + Allograft | PROMIS Scale v1.0 - Pain Intensity 3a Score at Month 6 Follow-Up | 50.6 T-score | Standard Deviation 2.5 |
| Recombinant Human Bone Morphogenetic Protein-2 (BMP) | PROMIS Scale v1.0 - Pain Intensity 3a Score at Month 6 Follow-Up | 51.3 T-score | Standard Deviation 1.9 |
| Autograft | PROMIS Scale v1.0 - Pain Intensity 3a Score at Month 6 Follow-Up | 52.8 T-score | Standard Deviation 2.8 |
Primary
PROMIS Scale v1.0 - Pain Intensity 3a Score at Pre-Op Visit
3-item self-report assessment of how much a participant hurts. Participants rank items on a 5-point Likert scale ranging from 0 (Had no pain) to 4 (Very severe). The raw score is the sum of responses and ranges from 0-12; lower scores indicate lower levels of pain. The raw score is translated to give a T-score for each participant. The T-score rescales the raw score into a standardized score ranging from 0-100, with a mean of 50 and a standard deviation (SD) of 10. Higher T-scores indicate higher intensity of pain.
Time frame: Pre-Operation Visit (Day 0)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Bone Marrow Aspirate Concentrate (BMAC) + Allograft | PROMIS Scale v1.0 - Pain Intensity 3a Score at Pre-Op Visit | 68.7 T-score | Standard Deviation 1.8 |
| Recombinant Human Bone Morphogenetic Protein-2 (BMP) | PROMIS Scale v1.0 - Pain Intensity 3a Score at Pre-Op Visit | 69.5 T-score | Standard Deviation 1.4 |
| Autograft | PROMIS Scale v1.0 - Pain Intensity 3a Score at Pre-Op Visit | 70.4 T-score | Standard Deviation 2.5 |
Primary
PROMIS Scale v1.0 - Pain Intensity 3a Score at Week 6 Follow-Up
3-item self-report assessment of how much a participant hurts. Participants rank items on a 5-point Likert scale ranging from 0 (Had no pain) to 4 (Very severe). The raw score is the sum of responses and ranges from 0-12; lower scores indicate lower levels of pain. The raw score is translated to give a T-score for each participant. The T-score rescales the raw score into a standardized score ranging from 0-100, with a mean of 50 and a standard deviation (SD) of 10. Higher T-scores indicate higher intensity of pain.
Time frame: Week 6 Post-Operation
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Bone Marrow Aspirate Concentrate (BMAC) + Allograft | PROMIS Scale v1.0 - Pain Intensity 3a Score at Week 6 Follow-Up | 61.3 T-score | Standard Deviation 3.4 |
| Recombinant Human Bone Morphogenetic Protein-2 (BMP) | PROMIS Scale v1.0 - Pain Intensity 3a Score at Week 6 Follow-Up | 62.4 T-score | Standard Deviation 2.9 |
| Autograft | PROMIS Scale v1.0 - Pain Intensity 3a Score at Week 6 Follow-Up | 60.1 T-score | Standard Deviation 3.3 |
Primary
SF-12 - MCS Score at Month 12 Follow-Up
The SF-12 MCS is a mental component summary score from the Short Form 12 (SF-12) health survey. The MCS portion of the survey comprises 6 items; the item scores are standardized to a final t-score. The final score ranges from 0-100 with a mean of 50. Higher scores indicate greater mental quality of life.
Time frame: Month 12 Post-Operation
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Bone Marrow Aspirate Concentrate (BMAC) + Allograft | SF-12 - MCS Score at Month 12 Follow-Up | 69.4 score on a scale | Standard Deviation 0.8 |
| Recombinant Human Bone Morphogenetic Protein-2 (BMP) | SF-12 - MCS Score at Month 12 Follow-Up | 67.7 score on a scale | Standard Deviation 2.9 |
| Autograft | SF-12 - MCS Score at Month 12 Follow-Up | 68.8 score on a scale | Standard Deviation 2.5 |
Primary
SF-12 - MCS Score at Month 24 Follow-Up
The SF-12 MCS is a mental component summary score from the Short Form 12 (SF-12) health survey. The MCS portion of the survey comprises 6 items; the item scores are standardized to a final t-score. The final score ranges from 0-100 with a mean of 50. Higher scores indicate greater mental quality of life.
Time frame: Month 12 Post-Operation
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Bone Marrow Aspirate Concentrate (BMAC) + Allograft | SF-12 - MCS Score at Month 24 Follow-Up | 74.2 score on a scale | Standard Deviation 2.4 |
| Recombinant Human Bone Morphogenetic Protein-2 (BMP) | SF-12 - MCS Score at Month 24 Follow-Up | 75.6 score on a scale | Standard Deviation 3.1 |
| Autograft | SF-12 - MCS Score at Month 24 Follow-Up | 75.2 score on a scale | Standard Deviation 2 |
Primary
SF-12 - MCS Score at Month 3 Follow-Up
The SF-12 MCS is a mental component summary score from the Short Form 12 (SF-12) health survey. The MCS portion of the survey comprises 6 items; the item scores are standardized to a final t-score. The final score ranges from 0-100 with a mean of 50. Higher scores indicate greater mental quality of life.
Time frame: Month 3 Follow-Up Post-Operation
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Bone Marrow Aspirate Concentrate (BMAC) + Allograft | SF-12 - MCS Score at Month 3 Follow-Up | 58.9 score on a scale | Standard Deviation 1.5 |
| Recombinant Human Bone Morphogenetic Protein-2 (BMP) | SF-12 - MCS Score at Month 3 Follow-Up | 57.7 score on a scale | Standard Deviation 1.3 |
| Autograft | SF-12 - MCS Score at Month 3 Follow-Up | 57.8 score on a scale | Standard Deviation 1.1 |
Primary
SF-12 - MCS Score at Month 6 Follow-Up
The SF-12 MCS is a mental component summary score from the Short Form 12 (SF-12) health survey. The MCS portion of the survey comprises 6 items; the item scores are standardized to a final t-score. The final score ranges from 0-100 with a mean of 50. Higher scores indicate greater mental quality of life.
Time frame: Month 6 Post-Operation
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Bone Marrow Aspirate Concentrate (BMAC) + Allograft | SF-12 - MCS Score at Month 6 Follow-Up | 63.1 score on a scale | Standard Deviation 1.5 |
| Recombinant Human Bone Morphogenetic Protein-2 (BMP) | SF-12 - MCS Score at Month 6 Follow-Up | 65.5 score on a scale | Standard Deviation 1.2 |
| Autograft | SF-12 - MCS Score at Month 6 Follow-Up | 65.2 score on a scale | Standard Deviation 0.9 |
Primary
SF-12 - MCS Score at Week 6 Follow-Up
The SF-12 MCS is a mental component summary score from the Short Form 12 (SF-12) health survey. The MCS portion of the survey comprises 6 items; the item scores are standardized to a final t-score. The final score ranges from 0-100 with a mean of 50. Higher scores indicate greater mental quality of life.
Time frame: Week 6 Post-Operation
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Bone Marrow Aspirate Concentrate (BMAC) + Allograft | SF-12 - MCS Score at Week 6 Follow-Up | 58.6 score on a scale | Standard Deviation 1.1 |
| Recombinant Human Bone Morphogenetic Protein-2 (BMP) | SF-12 - MCS Score at Week 6 Follow-Up | 57.5 score on a scale | Standard Deviation 0.8 |
| Autograft | SF-12 - MCS Score at Week 6 Follow-Up | 58.1 score on a scale | Standard Deviation 1.7 |
Primary
SF-12 - Mental Component Summary (MCS) Score at Pre-Op Visit
The SF-12 MCS is a mental component summary score from the Short Form 12 (SF-12) health survey. The MCS portion of the survey comprises 6 items; the item scores are standardized to a final t-score. The final score ranges from 0-100 with a mean of 50. Higher scores indicate greater mental quality of life.
Time frame: Pre-Operation Visit (Day 0)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Bone Marrow Aspirate Concentrate (BMAC) + Allograft | SF-12 - Mental Component Summary (MCS) Score at Pre-Op Visit | 51.9 score on a scale | Standard Deviation 2.6 |
| Recombinant Human Bone Morphogenetic Protein-2 (BMP) | SF-12 - Mental Component Summary (MCS) Score at Pre-Op Visit | 53.4 score on a scale | Standard Deviation 1.7 |
| Autograft | SF-12 - Mental Component Summary (MCS) Score at Pre-Op Visit | 55.1 score on a scale | Standard Deviation 1.9 |
Primary
SF-12 - PCS Score at Month 12 Follow-Up
The SF-12 PCS is a physical component summary score from the Short Form 12 (SF-12) health survey. The PCS portion of the survey comprises 6 items; the item scores are standardized to a final t-score. The final score ranges from 0-100 with a mean of 50. Higher scores indicate greater physical quality of life.
Time frame: Month 12 Post-Operation
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Bone Marrow Aspirate Concentrate (BMAC) + Allograft | SF-12 - PCS Score at Month 12 Follow-Up | 64.2 score on a scale | Standard Deviation 1.7 |
| Recombinant Human Bone Morphogenetic Protein-2 (BMP) | SF-12 - PCS Score at Month 12 Follow-Up | 61.6 score on a scale | Standard Deviation 1.5 |
| Autograft | SF-12 - PCS Score at Month 12 Follow-Up | 62.8 score on a scale | Standard Deviation 0.9 |
Primary
SF-12 - PCS Score at Month 24 Follow-Up
The SF-12 PCS is a physical component summary score from the Short Form 12 (SF-12) health survey. The PCS portion of the survey comprises 6 items; the item scores are standardized to a final t-score. The final score ranges from 0-100 with a mean of 50. Higher scores indicate greater physical quality of life.
Time frame: Month 24 Post-Operation
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Bone Marrow Aspirate Concentrate (BMAC) + Allograft | SF-12 - PCS Score at Month 24 Follow-Up | 69.4 score on a scale | Standard Deviation 0.8 |
| Recombinant Human Bone Morphogenetic Protein-2 (BMP) | SF-12 - PCS Score at Month 24 Follow-Up | 67.7 score on a scale | Standard Deviation 1.5 |
| Autograft | SF-12 - PCS Score at Month 24 Follow-Up | 70.2 score on a scale | Standard Deviation 1.2 |
Primary
SF-12 - PCS Score at Month 3 Follow-Up
The SF-12 PCS is a physical component summary score from the Short Form 12 (SF-12) health survey. The PCS portion of the survey comprises 6 items; the item scores are standardized to a final t-score. The final score ranges from 0-100 with a mean of 50. Higher scores indicate greater physical quality of life.
Time frame: Month 3 Post-Operation
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Bone Marrow Aspirate Concentrate (BMAC) + Allograft | SF-12 - PCS Score at Month 3 Follow-Up | 44.5 score on a scale | Standard Deviation 1.3 |
| Recombinant Human Bone Morphogenetic Protein-2 (BMP) | SF-12 - PCS Score at Month 3 Follow-Up | 48.4 score on a scale | Standard Deviation 0.8 |
| Autograft | SF-12 - PCS Score at Month 3 Follow-Up | 47.2 score on a scale | Standard Deviation 1 |
Primary
SF-12 - PCS Score at Month 6 Follow-Up
The SF-12 PCS is a physical component summary score from the Short Form 12 (SF-12) health survey. The PCS portion of the survey comprises 6 items; the item scores are standardized to a final t-score. The final score ranges from 0-100 with a mean of 50. Higher scores indicate greater physical quality of life.
Time frame: Month 6 Post-Operation
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Bone Marrow Aspirate Concentrate (BMAC) + Allograft | SF-12 - PCS Score at Month 6 Follow-Up | 49.5 score on a scale | Standard Deviation 0.9 |
| Recombinant Human Bone Morphogenetic Protein-2 (BMP) | SF-12 - PCS Score at Month 6 Follow-Up | 50.1 score on a scale | Standard Deviation 1.2 |
| Autograft | SF-12 - PCS Score at Month 6 Follow-Up | 48.8 score on a scale | Standard Deviation 1 |
Primary
SF-12 - PCS Score at Week 6 Follow-Up
The SF-12 PCS is a physical component summary score from the Short Form 12 (SF-12) health survey. The PCS portion of the survey comprises 6 items; the item scores are standardized to a final t-score. The final score ranges from 0-100 with a mean of 50. Higher scores indicate greater physical quality of life.
Time frame: Week 6 Post-Operation
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Bone Marrow Aspirate Concentrate (BMAC) + Allograft | SF-12 - PCS Score at Week 6 Follow-Up | 44.5 score on a scale | Standard Deviation 1.3 |
| Recombinant Human Bone Morphogenetic Protein-2 (BMP) | SF-12 - PCS Score at Week 6 Follow-Up | 48.4 score on a scale | Standard Deviation 0.8 |
| Autograft | SF-12 - PCS Score at Week 6 Follow-Up | 47.2 score on a scale | Standard Deviation 1 |
Primary
Short Form 12 (SF-12) - Physical Component Summary (PCS) Score at Pre-Op Visit
The SF-12 PCS is a physical component summary score from the Short Form 12 (SF-12) health survey. The PCS portion of the survey comprises 6 items; the item scores are standardized to a final t-score. The final score ranges from 0-100 with a mean of 50. Higher scores indicate greater physical quality of life.
Time frame: Pre-Operation Visit (Day 0)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Bone Marrow Aspirate Concentrate (BMAC) + Allograft | Short Form 12 (SF-12) - Physical Component Summary (PCS) Score at Pre-Op Visit | 42.5 score on a scale | Standard Deviation 0.9 |
| Recombinant Human Bone Morphogenetic Protein-2 (BMP) | Short Form 12 (SF-12) - Physical Component Summary (PCS) Score at Pre-Op Visit | 47.6 score on a scale | Standard Deviation 2.4 |
| Autograft | Short Form 12 (SF-12) - Physical Component Summary (PCS) Score at Pre-Op Visit | 45.8 score on a scale | Standard Deviation 1.8 |