Degenerative Disc Disease, Spinal Stenosis, Spondylolisthesis
Conditions
Keywords
Spinal stenosis, Spondylolisthesis, Degenerative disc disease, Spinal fusion, Allograft, Interbody fusion
Brief summary
The purpose of this study is to evaluate fusion status and patient outcomes observed from use of the VESUVIUS Demineralized Fibers with the EVEREST Spinal System as compared to the literature reported outcomes of spinal fusion using autograft with posterior stabilization.
Interventions
None listed
Sponsors
K2M, Inc.
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Diagnosis of non-cervical spinal stenosis; spondylolisthesis (grade 1 or 2); and/or degenerative disc disease (DDD) with one or two contiguous levels requiring surgical intervention between L1-S1. Qualified patients will be confirmed for inclusion by patient history and radiographic studies * Willing and able to comply with the requirements of the protocol including follow-up requirements * Willing and able to sign a study specific informed consent * Skeletally mature and I 18 years old at time of enrollment
Exclusion criteria
* Previous spine surgery at the index level * Previous posterior spine surgery (e.g., posterior decompression) that destabilizes the lumbar spine * Active systemic infection or infection at the operative site * Co-morbid medical conditions of the spine or upper/lower extremities that may affect the lumbar spine neurological and/or pain assessment * Metabolic bone disease such as osteoporosis and osteopenia that contradicts spinal surgery * History of an osteoporotic fracture * History of an endocrine or metabolic disorder (e.g., Paget's disease) known to affect bone and mineral metabolism * Taking medications that may interfere with bony/soft tissue healing including chronic steroid use * Known allergy to titanium or cobalt chrome * Rheumatoid arthritis or other autoimmune disease or a systemic disorder such as HIV, active hepatitis B or C, or fibromyalgia * Insulin-dependent type 1 or type 2 diabetes * Medical condition (e.g., unstable cardiac disease, cancer) that may result in patient death or have an effect on outcomes prior to study completion * Pregnant, or intends to become pregnant, during the course of the study * Severe obesity (Body Mass Index \> 40) * Physical or mental condition (e.g., psychiatric disorder, senile dementia, Alzheimer's disease, alcohol or drug addiction) that would interfere with patient self-assessment of function, pain, or quality of life. * Involved in current or pending spinal litigation where permanent disability benefits are being sought * Incarcerated at the time of study enrollment * Current participation in an investigational study that may impact study outcomes
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Adverse Events | 24 months | All adverse events will be documented including device related, procedure related and additional serious adverse events. |
| Fusion Status on CT at 12 Months | 12 months | Fusion is categorized as Partial consolidation and Bridging/Fusion. Partial consolidation is defined as consolidation of bone graft material with no complete bridging seen. Bridging/Fusion is defined as clear evidence of solid bridging bone between posterolateral gutters, facet joints and/or transverse processes. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Pain Scores on the Visual Analog Scale (VAS) at 24 Months | Baseline (up to 8 weeks post-operatively) to 24 months | VAS scale ranged from 0 to 100mm with the 100mm accounting for the highest level of pain |
| Change From Baseline in Quality of Life Scores on the SF-12v2 at 24 Months | Baseline (up to 8 weeks post-operatively) to 24 months | SF-12v2 ranged between 0 and 100 points. The higher the points the better the self-assessed quality of life. |
| Patient Satisfaction | 12 months, 24 months | Patient Satisfaction at 12 Mo and 24 Mo |
| Length of Surgery Time | At time of surgery | The length of the surgical procedure from the initial incision to final closure. |
| Radiographic Assessments | 12m | X-rays at pre-operative and post operative include: AP& Lateral; Flex/Ext & Oblique X-rays. Radiographic assessments being performed include: * Posterior/Transverse process fusion, Right side (by level) * Posterior/Transverse process fusion, Left side (by level) * Anterior fusion, if TLIF procedure done, by level * Overall fusion by level * Device Condition * Device Subsidence * Device Migration |
| Estimated Blood Loss | At time of surgery | The amount of blood loss over the entire length of the surgery |
| Length of Hospital Stay | Admission to discharge | The length of the hospital stay from the date of admission to the date of discharge . |
| Time to Return to Work/School | Pre-Op to 24 months | The ability to and the time it takes for the subject to be cleared to return to work/school from the date of surgery by looking at the percentage increase of participants who were able to return to work without any restrictions. |
| Use of Narcotics Post-surgery | Pre-Op to 24 months | The types and dosages of any narcotics taken by the patient post-surgery will be documented. |
| Length of Anesthesia Time | At time of surgery | The length of time the patient is under anesthesia. |
| Change From Baseline in Daily Functional Ability Scores on the Oswestry Disability Index (ODI) | Baseline (Pre-Op), 24 months | This patient-reported outcome measure is a 10 item questionnaire that evaluates disability and functional impairment associated with back problems. Each item is scored from 0 up to 5, with higher scores corresponding to greater disability. A total ODI score is determined by adding the scores of the individual questions and dividing that total by the maximum possible score (i.e., 50 if all questions are answered) to yield a percentage. Therefore, the ODI score ranges from 0% to 100%. |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Demographics and Baseline Characteristics Demographics and Baseline Characteristics (Patient Population) | 108 |
| Total | 108 |
Baseline characteristics
| Characteristic | Demographics and Baseline Characteristics |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 45 Participants |
| Age, Categorical Between 18 and 65 years | 63 Participants |
| Age, Continuous | 59.45 years STANDARD_DEVIATION 13.31 |
| Body Mass Index (BMI) | 29.61 lbs/(in^2)*703 STANDARD_DEVIATION 4.86 |
| Height | 66.57 inches STANDARD_DEVIATION 4.09 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 0 Participants |
| Region of Enrollment United States | 108 participants |
| Sex: Female, Male Female | 56 Participants |
| Sex: Female, Male Male | 52 Participants |
| Tobacco Use Currently Use | 16 Participants |
| Tobacco Use Missing | 0 Participants |
| Tobacco Use Never | 47 Participants |
| Tobacco Use Quit | 45 Participants |
| Weight | 187.19 pounds STANDARD_DEVIATION 37.67 |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 108 |
| other Total, other adverse events | 73 / 108 |
| serious Total, serious adverse events | 25 / 108 |
Outcome results
Primary
Fusion Status on CT at 12 Months
Fusion is categorized as Partial consolidation and Bridging/Fusion. Partial consolidation is defined as consolidation of bone graft material with no complete bridging seen. Bridging/Fusion is defined as clear evidence of solid bridging bone between posterolateral gutters, facet joints and/or transverse processes.
Time frame: 12 months
Population: Image Assessed at Visit
| Arm | Measure | Category | Value (COUNT_OF_UNITS) |
|---|---|---|---|
| Up to Post Operative | Fusion Status on CT at 12 Months | Fused | 63 Number of Image Assessed |
| Up to Post Operative | Fusion Status on CT at 12 Months | Not Fused | 17 Number of Image Assessed |
Primary
Number of Participants With Adverse Events
All adverse events will be documented including device related, procedure related and additional serious adverse events.
Time frame: 24 months
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Up to Post Operative | Number of Participants With Adverse Events | Any SAE: Mild | 3 participants |
| Up to Post Operative | Number of Participants With Adverse Events | Any AE | 51 participants |
| Up to Post Operative | Number of Participants With Adverse Events | Any SAE: Device Related | 2 participants |
| Up to Post Operative | Number of Participants With Adverse Events | Any AE: Procedure Related | 28 participants |
| Up to Post Operative | Number of Participants With Adverse Events | Any SAE: Procedure Related | 10 participants |
| Up to Post Operative | Number of Participants With Adverse Events | Any AE: Severe | 10 participants |
| Up to Post Operative | Number of Participants With Adverse Events | Any SAE: Moderate | 6 participants |
| Up to Post Operative | Number of Participants With Adverse Events | Any AE: Moderate | 34 participants |
| Up to Post Operative | Number of Participants With Adverse Events | Any AE: Mild | 21 participants |
| Up to Post Operative | Number of Participants With Adverse Events | Any AE: Device Related | 2 participants |
| Up to Post Operative | Number of Participants With Adverse Events | Any SAE: Severe | 7 participants |
| Up to Post Operative | Number of Participants With Adverse Events | Any SAE | 16 participants |
| Post-Operative to 3 Months | Number of Participants With Adverse Events | Any SAE: Severe | 0 participants |
| Post-Operative to 3 Months | Number of Participants With Adverse Events | Any AE: Severe | 0 participants |
| Post-Operative to 3 Months | Number of Participants With Adverse Events | Any AE: Mild | 5 participants |
| Post-Operative to 3 Months | Number of Participants With Adverse Events | Any SAE: Mild | 0 participants |
| Post-Operative to 3 Months | Number of Participants With Adverse Events | Any SAE: Procedure Related | 0 participants |
| Post-Operative to 3 Months | Number of Participants With Adverse Events | Any AE: Moderate | 10 participants |
| Post-Operative to 3 Months | Number of Participants With Adverse Events | Any SAE: Moderate | 0 participants |
| Post-Operative to 3 Months | Number of Participants With Adverse Events | Any AE | 15 participants |
| Post-Operative to 3 Months | Number of Participants With Adverse Events | Any AE: Procedure Related | 0 participants |
| Post-Operative to 3 Months | Number of Participants With Adverse Events | Any SAE | 0 participants |
| Post-Operative to 3 Months | Number of Participants With Adverse Events | Any SAE: Device Related | 0 participants |
| Post-Operative to 3 Months | Number of Participants With Adverse Events | Any AE: Device Related | 0 participants |
| 3 to 6 Months | Number of Participants With Adverse Events | Any AE: Moderate | 14 participants |
| 3 to 6 Months | Number of Participants With Adverse Events | Any AE: Severe | 4 participants |
| 3 to 6 Months | Number of Participants With Adverse Events | Any SAE: Moderate | 2 participants |
| 3 to 6 Months | Number of Participants With Adverse Events | Any AE: Procedure Related | 1 participants |
| 3 to 6 Months | Number of Participants With Adverse Events | Any AE | 19 participants |
| 3 to 6 Months | Number of Participants With Adverse Events | Any SAE: Device Related | 0 participants |
| 3 to 6 Months | Number of Participants With Adverse Events | Any AE: Device Related | 0 participants |
| 3 to 6 Months | Number of Participants With Adverse Events | Any SAE: Severe | 1 participants |
| 3 to 6 Months | Number of Participants With Adverse Events | Any SAE: Procedure Related | 0 participants |
| 3 to 6 Months | Number of Participants With Adverse Events | Any AE: Mild | 4 participants |
| 3 to 6 Months | Number of Participants With Adverse Events | Any SAE: Mild | 0 participants |
| 3 to 6 Months | Number of Participants With Adverse Events | Any SAE | 4 participants |
| 6 to 12 Months | Number of Participants With Adverse Events | Any AE: Procedure Related | 1 participants |
| 6 to 12 Months | Number of Participants With Adverse Events | Any AE | 23 participants |
| 6 to 12 Months | Number of Participants With Adverse Events | Any AE: Moderate | 17 participants |
| 6 to 12 Months | Number of Participants With Adverse Events | Any SAE: Moderate | 2 participants |
| 6 to 12 Months | Number of Participants With Adverse Events | Any AE: Device Related | 0 participants |
| 6 to 12 Months | Number of Participants With Adverse Events | Any AE: Mild | 5 participants |
| 6 to 12 Months | Number of Participants With Adverse Events | Any AE: Severe | 4 participants |
| 6 to 12 Months | Number of Participants With Adverse Events | Any SAE | 5 participants |
| 6 to 12 Months | Number of Participants With Adverse Events | Any SAE: Procedure Related | 0 participants |
| 6 to 12 Months | Number of Participants With Adverse Events | Any SAE: Device Related | 0 participants |
| 6 to 12 Months | Number of Participants With Adverse Events | Any SAE: Mild | 0 participants |
| 6 to 12 Months | Number of Participants With Adverse Events | Any SAE: Severe | 3 participants |
| 12 to 24+ Months | Number of Participants With Adverse Events | Any AE: Mild | 8 participants |
| 12 to 24+ Months | Number of Participants With Adverse Events | Any AE: Device Related | 1 participants |
| 12 to 24+ Months | Number of Participants With Adverse Events | Any SAE: Moderate | 1 participants |
| 12 to 24+ Months | Number of Participants With Adverse Events | Any AE: Moderate | 17 participants |
| 12 to 24+ Months | Number of Participants With Adverse Events | Any SAE: Severe | 2 participants |
| 12 to 24+ Months | Number of Participants With Adverse Events | Any SAE: Mild | 0 participants |
| 12 to 24+ Months | Number of Participants With Adverse Events | Any AE | 24 participants |
| 12 to 24+ Months | Number of Participants With Adverse Events | Any AE: Procedure Related | 4 participants |
| 12 to 24+ Months | Number of Participants With Adverse Events | Any AE: Severe | 2 participants |
| 12 to 24+ Months | Number of Participants With Adverse Events | Any SAE: Procedure Related | 1 participants |
| 12 to 24+ Months | Number of Participants With Adverse Events | Any SAE: Device Related | 0 participants |
| 12 to 24+ Months | Number of Participants With Adverse Events | Any SAE | 3 participants |
| Overall | Number of Participants With Adverse Events | Any SAE: Device Related | 2 participants |
| Overall | Number of Participants With Adverse Events | Any AE: Mild | 36 participants |
| Overall | Number of Participants With Adverse Events | Any AE: Device Related | 3 participants |
| Overall | Number of Participants With Adverse Events | Any SAE: Procedure Related | 11 participants |
| Overall | Number of Participants With Adverse Events | Any AE: Procedure Related | 50 participants |
| Overall | Number of Participants With Adverse Events | Any SAE: Severe | 12 participants |
| Overall | Number of Participants With Adverse Events | Any SAE | 25 participants |
| Overall | Number of Participants With Adverse Events | Any SAE: Moderate | 11 participants |
| Overall | Number of Participants With Adverse Events | Any SAE: Mild | 3 participants |
| Overall | Number of Participants With Adverse Events | Any AE: Severe | 19 participants |
| Overall | Number of Participants With Adverse Events | Any AE: Moderate | 60 participants |
| Overall | Number of Participants With Adverse Events | Any AE | 76 participants |
Secondary
Change From Baseline in Daily Functional Ability Scores on the Oswestry Disability Index (ODI)
This patient-reported outcome measure is a 10 item questionnaire that evaluates disability and functional impairment associated with back problems. Each item is scored from 0 up to 5, with higher scores corresponding to greater disability. A total ODI score is determined by adding the scores of the individual questions and dividing that total by the maximum possible score (i.e., 50 if all questions are answered) to yield a percentage. Therefore, the ODI score ranges from 0% to 100%.
Time frame: Baseline (Pre-Op), 24 months
Population: While 53 participants completed the study, 1 patient did not complete the survey at 24 Month.~2 patient did not complete the survey at 12 Month. 5 patient did not complete the survey at 6 Month. 4 patient did not complete the survey at 3 Month. 2 patient did not complete the survey at Initial Post-Op.~1 patient did not complete the survey at Pre-Op.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Up to Post Operative | Change From Baseline in Daily Functional Ability Scores on the Oswestry Disability Index (ODI) | Baseline | 45.1 score on a scale | Standard Deviation 17.2 |
| Up to Post Operative | Change From Baseline in Daily Functional Ability Scores on the Oswestry Disability Index (ODI) | Change from Baseline | NA score on a scale | — |
| Post-Operative to 3 Months | Change From Baseline in Daily Functional Ability Scores on the Oswestry Disability Index (ODI) | Baseline | 36.4 score on a scale | Standard Deviation 19.5 |
| Post-Operative to 3 Months | Change From Baseline in Daily Functional Ability Scores on the Oswestry Disability Index (ODI) | Change from Baseline | -8.0 score on a scale | Standard Deviation 20.9 |
| 3 to 6 Months | Change From Baseline in Daily Functional Ability Scores on the Oswestry Disability Index (ODI) | Baseline | 24.3 score on a scale | Standard Deviation 18.3 |
| 3 to 6 Months | Change From Baseline in Daily Functional Ability Scores on the Oswestry Disability Index (ODI) | Change from Baseline | -20.3 score on a scale | Standard Deviation 19.9 |
| 6 to 12 Months | Change From Baseline in Daily Functional Ability Scores on the Oswestry Disability Index (ODI) | Baseline | 20.5 score on a scale | Standard Deviation 18.2 |
| 6 to 12 Months | Change From Baseline in Daily Functional Ability Scores on the Oswestry Disability Index (ODI) | Change from Baseline | -24.4 score on a scale | Standard Deviation 19.7 |
| 12 to 24+ Months | Change From Baseline in Daily Functional Ability Scores on the Oswestry Disability Index (ODI) | Baseline | 18.0 score on a scale | Standard Deviation 18.3 |
| 12 to 24+ Months | Change From Baseline in Daily Functional Ability Scores on the Oswestry Disability Index (ODI) | Change from Baseline | -25.8 score on a scale | Standard Deviation 18.9 |
| Overall | Change From Baseline in Daily Functional Ability Scores on the Oswestry Disability Index (ODI) | Baseline | 16.6 score on a scale | Standard Deviation 18.4 |
| Overall | Change From Baseline in Daily Functional Ability Scores on the Oswestry Disability Index (ODI) | Change from Baseline | -26.3 score on a scale | Standard Deviation 21 |
Secondary
Change From Baseline in Pain Scores on the Visual Analog Scale (VAS) at 24 Months
VAS scale ranged from 0 to 100mm with the 100mm accounting for the highest level of pain
Time frame: Baseline (up to 8 weeks post-operatively) to 24 months
Population: While 53 participants completed the study, 1-2 patients did not complete the survey
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Up to Post Operative | Change From Baseline in Pain Scores on the Visual Analog Scale (VAS) at 24 Months | -44.3 score on a scale | Standard Deviation 30.51 |
| Post-Operative to 3 Months | Change From Baseline in Pain Scores on the Visual Analog Scale (VAS) at 24 Months | -38.6 score on a scale | Standard Deviation 35.82 |
| 3 to 6 Months | Change From Baseline in Pain Scores on the Visual Analog Scale (VAS) at 24 Months | -27.9 score on a scale | Standard Deviation 39.02 |
| 6 to 12 Months | Change From Baseline in Pain Scores on the Visual Analog Scale (VAS) at 24 Months | -37.9 score on a scale | Standard Deviation 38.9 |
| 12 to 24+ Months | Change From Baseline in Pain Scores on the Visual Analog Scale (VAS) at 24 Months | -36.1 score on a scale | Standard Deviation 42.9 |
Secondary
Change From Baseline in Quality of Life Scores on the SF-12v2 at 24 Months
SF-12v2 ranged between 0 and 100 points. The higher the points the better the self-assessed quality of life.
Time frame: Baseline (up to 8 weeks post-operatively) to 24 months
Population: While 53 participants completed the study, 1 patient did not complete the survey.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Up to Post Operative | Change From Baseline in Quality of Life Scores on the SF-12v2 at 24 Months | 4.603 score on a scale | Standard Deviation 10.257 |
| Post-Operative to 3 Months | Change From Baseline in Quality of Life Scores on the SF-12v2 at 24 Months | 11.734 score on a scale | Standard Deviation 10.042 |
Secondary
Estimated Blood Loss
The amount of blood loss over the entire length of the surgery
Time frame: At time of surgery
Population: 1 Subject did not have the amount of blood loss recorded
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Up to Post Operative | Estimated Blood Loss | 250.50 Cubic Centimeters | Standard Deviation 238.79 |
Secondary
Length of Anesthesia Time
The length of time the patient is under anesthesia.
Time frame: At time of surgery
Population: 6 Subjects did not have anesthesia time recorded
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Up to Post Operative | Length of Anesthesia Time | 4.23 Hours | Standard Deviation 1.4 |
Secondary
Length of Hospital Stay
The length of the hospital stay from the date of admission to the date of discharge .
Time frame: Admission to discharge
Population: All patients are accounted for
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Up to Post Operative | Length of Hospital Stay | 4.15 Days | Standard Deviation 1.83 |
Secondary
Length of Surgery Time
The length of the surgical procedure from the initial incision to final closure.
Time frame: At time of surgery
Population: 5 Subjects did not have a surgical time recorded
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Up to Post Operative | Length of Surgery Time | 3.12 Hours | Standard Deviation 1.29 |
Secondary
Patient Satisfaction
Patient Satisfaction at 12 Mo and 24 Mo
Time frame: 12 months, 24 months
Population: All participants for both intervals filled out the surveys
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Up to Post Operative | Patient Satisfaction | Repeat Procedure | No | 5 Participants |
| Up to Post Operative | Patient Satisfaction | Satisfied | Not Reported | 8 Participants |
| Up to Post Operative | Patient Satisfaction | Satisfied | Yes | 72 Participants |
| Up to Post Operative | Patient Satisfaction | Repeat Procedure | Yes | 71 Participants |
| Up to Post Operative | Patient Satisfaction | Repeat Procedure | Not Reported | 9 Participants |
| Up to Post Operative | Patient Satisfaction | Satisfied | No | 5 Participants |
| Post-Operative to 3 Months | Patient Satisfaction | Repeat Procedure | Not Reported | 4 Participants |
| Post-Operative to 3 Months | Patient Satisfaction | Satisfied | Yes | 43 Participants |
| Post-Operative to 3 Months | Patient Satisfaction | Satisfied | No | 6 Participants |
| Post-Operative to 3 Months | Patient Satisfaction | Satisfied | Not Reported | 4 Participants |
| Post-Operative to 3 Months | Patient Satisfaction | Repeat Procedure | Yes | 45 Participants |
| Post-Operative to 3 Months | Patient Satisfaction | Repeat Procedure | No | 4 Participants |
Secondary
Radiographic Assessments
X-rays at post operative include: AP& Lateral; Flex/Ext & Oblique X-rays. Radiographic assessments being performed include: Device Condition Device Subsidence Device Migration
Time frame: 12 Months and 24 Months
Population: The participants data analyzed differ from the overall number of participants for the Arms. Cages were optional per protocol as such the decrease in the number of participants.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Up to Post Operative | Radiographic Assessments | 24 Mo Hardware Condition | Unable to assess | 2 Participants |
| Up to Post Operative | Radiographic Assessments | 12 Mo Cage Condition | Bridging/Fusion | 10 Participants |
| Up to Post Operative | Radiographic Assessments | 12 Mo Hardware Condition | Unable to assess | 0 Participants |
| Up to Post Operative | Radiographic Assessments | 12 Mo Cage Condition | Unable to assess | 1 Participants |
| Up to Post Operative | Radiographic Assessments | 24 Mo Cage Condition | Intact | 0 Participants |
| Up to Post Operative | Radiographic Assessments | 12 Mo Hardware Condition | Fracture | 1 Participants |
| Up to Post Operative | Radiographic Assessments | 24 Mo Cage Condition | Loosening | 0 Participants |
| Up to Post Operative | Radiographic Assessments | 24 Mo Hardware Condition | Intact | 32 Participants |
| Up to Post Operative | Radiographic Assessments | 24 Mo Cage Condition | Fracture | 0 Participants |
| Up to Post Operative | Radiographic Assessments | 24 Mo Cage Condition | Absent | 3 Participants |
| Up to Post Operative | Radiographic Assessments | 24 Mo Cage Condition | Partial Consolidation | 1 Participants |
| Up to Post Operative | Radiographic Assessments | 24 Mo Hardware Condition | Loosening | 4 Participants |
| Up to Post Operative | Radiographic Assessments | 24 Mo Cage Condition | Bridging/Fusion | 12 Participants |
| Up to Post Operative | Radiographic Assessments | 24 Mo Cage Condition | Unable to assess | 1 Participants |
| Up to Post Operative | Radiographic Assessments | 12 Mo Hardware Condition | Intact | 51 Participants |
| Up to Post Operative | Radiographic Assessments | 24 Mo Hardware Condition | Fracture | 1 Participants |
| Up to Post Operative | Radiographic Assessments | 12 Mo Hardware Condition | Absent | 0 Participants |
| Up to Post Operative | Radiographic Assessments | 24 Mo Hardware Condition | Absent | 0 Participants |
| Up to Post Operative | Radiographic Assessments | 24 Mo Hardware Condition | Partial Consolidation | 0 Participants |
| Up to Post Operative | Radiographic Assessments | 12 Mo Hardware Condition | Loosening | 12 Participants |
| Up to Post Operative | Radiographic Assessments | 24 Mo Hardware Condition | Bridging/Fusion | 0 Participants |
| Up to Post Operative | Radiographic Assessments | 12 Mo Hardware Condition | Partial Consolidation | 0 Participants |
| Up to Post Operative | Radiographic Assessments | 12 Mo Cage Condition | Intact | 0 Participants |
| Up to Post Operative | Radiographic Assessments | 12 Mo Cage Condition | Loosening | 0 Participants |
| Up to Post Operative | Radiographic Assessments | 12 Mo Hardware Condition | Bridging/Fusion | 0 Participants |
| Up to Post Operative | Radiographic Assessments | 12 Mo Cage Condition | Fracture | 0 Participants |
| Up to Post Operative | Radiographic Assessments | 12 Mo Cage Condition | Absent | 8 Participants |
| Up to Post Operative | Radiographic Assessments | 12 Mo Cage Condition | Partial Consolidation | 3 Participants |
| Post-Operative to 3 Months | Radiographic Assessments | 24 Mo Hardware Condition | Unable to assess | 0 Participants |
| Post-Operative to 3 Months | Radiographic Assessments | 12 Mo Hardware Condition | Intact | 16 Participants |
| Post-Operative to 3 Months | Radiographic Assessments | 12 Mo Hardware Condition | Partial Consolidation | 0 Participants |
| Post-Operative to 3 Months | Radiographic Assessments | 12 Mo Cage Condition | Bridging/Fusion | 2 Participants |
| Post-Operative to 3 Months | Radiographic Assessments | 24 Mo Hardware Condition | Fracture | 0 Participants |
| Post-Operative to 3 Months | Radiographic Assessments | 12 Mo Cage Condition | Absent | 2 Participants |
| Post-Operative to 3 Months | Radiographic Assessments | 12 Mo Cage Condition | Unable to assess | 1 Participants |
| Post-Operative to 3 Months | Radiographic Assessments | 12 Mo Hardware Condition | Unable to assess | 1 Participants |
| Post-Operative to 3 Months | Radiographic Assessments | 12 Mo Cage Condition | Intact | 0 Participants |
| Post-Operative to 3 Months | Radiographic Assessments | 24 Mo Cage Condition | Intact | 0 Participants |
| Post-Operative to 3 Months | Radiographic Assessments | 24 Mo Hardware Condition | Absent | 0 Participants |
| Post-Operative to 3 Months | Radiographic Assessments | 12 Mo Hardware Condition | Absent | 0 Participants |
| Post-Operative to 3 Months | Radiographic Assessments | 24 Mo Cage Condition | Loosening | 0 Participants |
| Post-Operative to 3 Months | Radiographic Assessments | 12 Mo Hardware Condition | Loosening | 4 Participants |
| Post-Operative to 3 Months | Radiographic Assessments | 24 Mo Hardware Condition | Partial Consolidation | 0 Participants |
| Post-Operative to 3 Months | Radiographic Assessments | 24 Mo Cage Condition | Fracture | 0 Participants |
| Post-Operative to 3 Months | Radiographic Assessments | 24 Mo Hardware Condition | Intact | 10 Participants |
| Post-Operative to 3 Months | Radiographic Assessments | 12 Mo Cage Condition | Fracture | 0 Participants |
| Post-Operative to 3 Months | Radiographic Assessments | 24 Mo Cage Condition | Absent | 1 Participants |
| Post-Operative to 3 Months | Radiographic Assessments | 12 Mo Hardware Condition | Fracture | 0 Participants |
| Post-Operative to 3 Months | Radiographic Assessments | 12 Mo Cage Condition | Loosening | 0 Participants |
| Post-Operative to 3 Months | Radiographic Assessments | 24 Mo Cage Condition | Partial Consolidation | 2 Participants |
| Post-Operative to 3 Months | Radiographic Assessments | 24 Mo Hardware Condition | Bridging/Fusion | 0 Participants |
| Post-Operative to 3 Months | Radiographic Assessments | 12 Mo Hardware Condition | Bridging/Fusion | 0 Participants |
| Post-Operative to 3 Months | Radiographic Assessments | 24 Mo Cage Condition | Bridging/Fusion | 2 Participants |
| Post-Operative to 3 Months | Radiographic Assessments | 12 Mo Cage Condition | Partial Consolidation | 5 Participants |
| Post-Operative to 3 Months | Radiographic Assessments | 24 Mo Cage Condition | Unable to assess | 1 Participants |
| Post-Operative to 3 Months | Radiographic Assessments | 24 Mo Hardware Condition | Loosening | 4 Participants |
| 3 to 6 Months | Radiographic Assessments | 24 Mo Cage Condition | Unable to assess | 1 Participants |
| 3 to 6 Months | Radiographic Assessments | 12 Mo Cage Condition | Absent | 4 Participants |
| 3 to 6 Months | Radiographic Assessments | 12 Mo Hardware Condition | Intact | 19 Participants |
| 3 to 6 Months | Radiographic Assessments | 12 Mo Hardware Condition | Loosening | 1 Participants |
| 3 to 6 Months | Radiographic Assessments | 12 Mo Hardware Condition | Fracture | 0 Participants |
| 3 to 6 Months | Radiographic Assessments | 12 Mo Hardware Condition | Absent | 0 Participants |
| 3 to 6 Months | Radiographic Assessments | 12 Mo Hardware Condition | Partial Consolidation | 0 Participants |
| 3 to 6 Months | Radiographic Assessments | 12 Mo Hardware Condition | Bridging/Fusion | 0 Participants |
| 3 to 6 Months | Radiographic Assessments | 12 Mo Hardware Condition | Unable to assess | 1 Participants |
| 3 to 6 Months | Radiographic Assessments | 24 Mo Hardware Condition | Intact | 13 Participants |
| 3 to 6 Months | Radiographic Assessments | 24 Mo Hardware Condition | Loosening | 1 Participants |
| 3 to 6 Months | Radiographic Assessments | 24 Mo Hardware Condition | Fracture | 0 Participants |
| 3 to 6 Months | Radiographic Assessments | 24 Mo Hardware Condition | Absent | 0 Participants |
| 3 to 6 Months | Radiographic Assessments | 24 Mo Hardware Condition | Partial Consolidation | 0 Participants |
| 3 to 6 Months | Radiographic Assessments | 24 Mo Hardware Condition | Bridging/Fusion | 0 Participants |
| 3 to 6 Months | Radiographic Assessments | 24 Mo Hardware Condition | Unable to assess | 0 Participants |
| 3 to 6 Months | Radiographic Assessments | 12 Mo Cage Condition | Intact | 0 Participants |
| 3 to 6 Months | Radiographic Assessments | 12 Mo Cage Condition | Loosening | 0 Participants |
| 3 to 6 Months | Radiographic Assessments | 12 Mo Cage Condition | Fracture | 0 Participants |
| 3 to 6 Months | Radiographic Assessments | 12 Mo Cage Condition | Partial Consolidation | 4 Participants |
| 3 to 6 Months | Radiographic Assessments | 12 Mo Cage Condition | Bridging/Fusion | 3 Participants |
| 3 to 6 Months | Radiographic Assessments | 12 Mo Cage Condition | Unable to assess | 1 Participants |
| 3 to 6 Months | Radiographic Assessments | 24 Mo Cage Condition | Intact | 0 Participants |
| 3 to 6 Months | Radiographic Assessments | 24 Mo Cage Condition | Loosening | 0 Participants |
| 3 to 6 Months | Radiographic Assessments | 24 Mo Cage Condition | Fracture | 0 Participants |
| 3 to 6 Months | Radiographic Assessments | 24 Mo Cage Condition | Absent | 1 Participants |
| 3 to 6 Months | Radiographic Assessments | 24 Mo Cage Condition | Partial Consolidation | 2 Participants |
| 3 to 6 Months | Radiographic Assessments | 24 Mo Cage Condition | Bridging/Fusion | 3 Participants |
Secondary
Radiographic Assessments
X-rays at pre-operative and post operative include: AP& Lateral; Flex/Ext & Oblique X-rays. Radiographic assessments being performed include: * Posterior/Transverse process fusion, Right side (by level) * Posterior/Transverse process fusion, Left side (by level) * Anterior fusion, if TLIF procedure done, by level * Overall fusion by level * Device Condition * Device Subsidence * Device Migration
Time frame: 12m
Population: Each Arm/group has different overall number of participants assessed.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Up to Post Operative | Radiographic Assessments | 3:2 (Vesuvius Fibers: BMA) | Bridging/Fusion | 13 Participants |
| Up to Post Operative | Radiographic Assessments | 3:2 (Vesuvius Fibers: BMA) | Partial Consolidation | 13 Participants |
| Up to Post Operative | Radiographic Assessments | 3:2 (Vesuvius Fibers: BMA) | Absent | 4 Participants |
| Up to Post Operative | Radiographic Assessments | 3:2 (Vesuvius Fibers: BMA) | Unknown | 1 Participants |
| Up to Post Operative | Radiographic Assessments | 1:1 (Vesuvius Fibers: BMA) | Bridging/Fusion | 7 Participants |
| Up to Post Operative | Radiographic Assessments | 1:1 (Vesuvius Fibers: BMA) | Partial Consolidation | 9 Participants |
| Up to Post Operative | Radiographic Assessments | 1:1 (Vesuvius Fibers: BMA) | Absent | 9 Participants |
| Up to Post Operative | Radiographic Assessments | 1:1 (Vesuvius Fibers: BMA) | Unknown | 1 Participants |
| Up to Post Operative | Radiographic Assessments | Other | Bridging/Fusion | 11 Participants |
| Up to Post Operative | Radiographic Assessments | Other | Partial Consolidation | 9 Participants |
| Up to Post Operative | Radiographic Assessments | Other | Absent | 5 Participants |
| Up to Post Operative | Radiographic Assessments | Other | Unknown | 2 Participants |
| Post-Operative to 3 Months | Radiographic Assessments | 1 Level | Bridging/Fusion | 27 Participants |
| Post-Operative to 3 Months | Radiographic Assessments | 1 Level | Partial Consolidation | 21 Participants |
| Post-Operative to 3 Months | Radiographic Assessments | 1 Level | Absent | 13 Participants |
| Post-Operative to 3 Months | Radiographic Assessments | 1 Level | Unknown | 3 Participants |
| Post-Operative to 3 Months | Radiographic Assessments | 2 Levels | Bridging/Fusion | 3 Participants |
| Post-Operative to 3 Months | Radiographic Assessments | 2 Levels | Partial Consolidation | 12 Participants |
| Post-Operative to 3 Months | Radiographic Assessments | 2 Levels | Absent | 4 Participants |
| Post-Operative to 3 Months | Radiographic Assessments | 2 Levels | Unknown | 1 Participants |
| 3 to 6 Months | Radiographic Assessments | L3-L4 | Bridging/Fusion | 5 Participants |
| 3 to 6 Months | Radiographic Assessments | L3-L4 | Partial Consolidation | 7 Participants |
| 3 to 6 Months | Radiographic Assessments | L3-L4 | Absent | 2 Participants |
| 3 to 6 Months | Radiographic Assessments | L3-L4 | Unknown | 0 Participants |
| 3 to 6 Months | Radiographic Assessments | L4-L5 | Bridging/Fusion | 22 Participants |
| 3 to 6 Months | Radiographic Assessments | L4-L5 | Partial Consolidation | 25 Participants |
| 3 to 6 Months | Radiographic Assessments | L4-L5 | Absent | 12 Participants |
| 3 to 6 Months | Radiographic Assessments | L4-L5 | Unknown | 4 Participants |
| 3 to 6 Months | Radiographic Assessments | L5-S1 | Bridging/Fusion | 7 Participants |
| 3 to 6 Months | Radiographic Assessments | L5-S1 | Partial Consolidation | 11 Participants |
| 3 to 6 Months | Radiographic Assessments | L5-S1 | Absent | 8 Participants |
| 3 to 6 Months | Radiographic Assessments | L5-S1 | Unknown | 1 Participants |
Secondary
Time to Return to Work/School
The ability to and the time it takes for the subject to be cleared to return to work/school from the date of surgery by looking at the percentage increase of participants who were able to return to work without any restrictions.
Time frame: Pre-Op to 24 months
Population: Includes all participants who returned for each visit interval with those who did not respond to this question accounted for in the missing row.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Up to Post Operative | Time to Return to Work/School | Unemployment, unrelated to back/leg conditions | 21 Participants |
| Up to Post Operative | Time to Return to Work/School | Not attending work/school by choice | 22 Participants |
| Up to Post Operative | Time to Return to Work/School | Unable to go due to back/leg pain/conditions | 14 Participants |
| Up to Post Operative | Time to Return to Work/School | Attending work/school with some restrictions | 20 Participants |
| Up to Post Operative | Time to Return to Work/School | Attending work/school with no restrictions | 31 Participants |
| Up to Post Operative | Time to Return to Work/School | Missing | 0 Participants |
| Post-Operative to 3 Months | Time to Return to Work/School | Not attending work/school by choice | 24 Participants |
| Post-Operative to 3 Months | Time to Return to Work/School | Attending work/school with some restrictions | 15 Participants |
| Post-Operative to 3 Months | Time to Return to Work/School | Missing | 0 Participants |
| Post-Operative to 3 Months | Time to Return to Work/School | Unemployment, unrelated to back/leg conditions | 19 Participants |
| Post-Operative to 3 Months | Time to Return to Work/School | Unable to go due to back/leg pain/conditions | 43 Participants |
| Post-Operative to 3 Months | Time to Return to Work/School | Attending work/school with no restrictions | 2 Participants |
| 3 to 6 Months | Time to Return to Work/School | Missing | 0 Participants |
| 3 to 6 Months | Time to Return to Work/School | Attending work/school with no restrictions | 19 Participants |
| 3 to 6 Months | Time to Return to Work/School | Attending work/school with some restrictions | 24 Participants |
| 3 to 6 Months | Time to Return to Work/School | Unable to go due to back/leg pain/conditions | 15 Participants |
| 3 to 6 Months | Time to Return to Work/School | Unemployment, unrelated to back/leg conditions | 20 Participants |
| 3 to 6 Months | Time to Return to Work/School | Not attending work/school by choice | 22 Participants |
| 6 to 12 Months | Time to Return to Work/School | Attending work/school with some restrictions | 18 Participants |
| 6 to 12 Months | Time to Return to Work/School | Not attending work/school by choice | 19 Participants |
| 6 to 12 Months | Time to Return to Work/School | Unable to go due to back/leg pain/conditions | 3 Participants |
| 6 to 12 Months | Time to Return to Work/School | Missing | 4 Participants |
| 6 to 12 Months | Time to Return to Work/School | Attending work/school with no restrictions | 28 Participants |
| 6 to 12 Months | Time to Return to Work/School | Unemployment, unrelated to back/leg conditions | 23 Participants |
| 12 to 24+ Months | Time to Return to Work/School | Unemployment, unrelated to back/leg conditions | 15 Participants |
| 12 to 24+ Months | Time to Return to Work/School | Attending work/school with no restrictions | 36 Participants |
| 12 to 24+ Months | Time to Return to Work/School | Not attending work/school by choice | 17 Participants |
| 12 to 24+ Months | Time to Return to Work/School | Unable to go due to back/leg pain/conditions | 4 Participants |
| 12 to 24+ Months | Time to Return to Work/School | Attending work/school with some restrictions | 10 Participants |
| 12 to 24+ Months | Time to Return to Work/School | Missing | 3 Participants |
| Overall | Time to Return to Work/School | Attending work/school with some restrictions | 1 Participants |
| Overall | Time to Return to Work/School | Unable to go due to back/leg pain/conditions | 5 Participants |
| Overall | Time to Return to Work/School | Attending work/school with no restrictions | 28 Participants |
| Overall | Time to Return to Work/School | Missing | 1 Participants |
| Overall | Time to Return to Work/School | Not attending work/school by choice | 16 Participants |
| Overall | Time to Return to Work/School | Unemployment, unrelated to back/leg conditions | 2 Participants |
Secondary
Use of Narcotics Post-surgery
The types and dosages of any narcotics taken by the patient post-surgery will be documented.
Time frame: Pre-Op to 24 months
Population: Includes all participants who returned for each visit interval with those who did not respond to this question accounted for in the missing row.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Up to Post Operative | Use of Narcotics Post-surgery | Back Meds | Chronic daily long-acting narcotics | 5 Participants |
| Up to Post Operative | Use of Narcotics Post-surgery | Back Meds | Non-narcotics or NSAIDs | 42 Participants |
| Up to Post Operative | Use of Narcotics Post-surgery | Back Meds | Intermittent short-acting narcotics | 20 Participants |
| Up to Post Operative | Use of Narcotics Post-surgery | Back Meds | Chronic daily short-acting narcotics | 26 Participants |
| Up to Post Operative | Use of Narcotics Post-surgery | Back Meds | None | 11 Participants |
| Up to Post Operative | Use of Narcotics Post-surgery | Back Meds | IV or injected narcotics | 1 Participants |
| Up to Post Operative | Use of Narcotics Post-surgery | Back Meds | Epidural/Facet injections | 3 Participants |
| Up to Post Operative | Use of Narcotics Post-surgery | Back Meds | Missing | 0 Participants |
| Up to Post Operative | Use of Narcotics Post-surgery | Non-Back Meds | None | 79 Participants |
| Up to Post Operative | Use of Narcotics Post-surgery | Non-Back Meds | Non-narcotics or NSAIDs | 20 Participants |
| Up to Post Operative | Use of Narcotics Post-surgery | Non-Back Meds | Intermittent short-acting narcotics | 6 Participants |
| Up to Post Operative | Use of Narcotics Post-surgery | Non-Back Meds | Chronic daily short-acting narcotics | 2 Participants |
| Up to Post Operative | Use of Narcotics Post-surgery | Non-Back Meds | Chronic daily long-acting narcotics | 1 Participants |
| Up to Post Operative | Use of Narcotics Post-surgery | Non-Back Meds | IV or injected narcotics | 0 Participants |
| Up to Post Operative | Use of Narcotics Post-surgery | Non-Back Meds | Epidural/Facet injections | 0 Participants |
| Up to Post Operative | Use of Narcotics Post-surgery | Non-Back Meds | Missing | 0 Participants |
| Post-Operative to 3 Months | Use of Narcotics Post-surgery | Back Meds | Chronic daily short-acting narcotics | 36 Participants |
| Post-Operative to 3 Months | Use of Narcotics Post-surgery | Non-Back Meds | None | 80 Participants |
| Post-Operative to 3 Months | Use of Narcotics Post-surgery | Back Meds | Missing | 0 Participants |
| Post-Operative to 3 Months | Use of Narcotics Post-surgery | Back Meds | Epidural/Facet injections | 0 Participants |
| Post-Operative to 3 Months | Use of Narcotics Post-surgery | Back Meds | Intermittent short-acting narcotics | 37 Participants |
| Post-Operative to 3 Months | Use of Narcotics Post-surgery | Back Meds | None | 9 Participants |
| Post-Operative to 3 Months | Use of Narcotics Post-surgery | Non-Back Meds | IV or injected narcotics | 0 Participants |
| Post-Operative to 3 Months | Use of Narcotics Post-surgery | Non-Back Meds | Chronic daily long-acting narcotics | 1 Participants |
| Post-Operative to 3 Months | Use of Narcotics Post-surgery | Non-Back Meds | Chronic daily short-acting narcotics | 0 Participants |
| Post-Operative to 3 Months | Use of Narcotics Post-surgery | Back Meds | Chronic daily long-acting narcotics | 6 Participants |
| Post-Operative to 3 Months | Use of Narcotics Post-surgery | Back Meds | Non-narcotics or NSAIDs | 15 Participants |
| Post-Operative to 3 Months | Use of Narcotics Post-surgery | Non-Back Meds | Missing | 0 Participants |
| Post-Operative to 3 Months | Use of Narcotics Post-surgery | Non-Back Meds | Intermittent short-acting narcotics | 7 Participants |
| Post-Operative to 3 Months | Use of Narcotics Post-surgery | Non-Back Meds | Non-narcotics or NSAIDs | 15 Participants |
| Post-Operative to 3 Months | Use of Narcotics Post-surgery | Non-Back Meds | Epidural/Facet injections | 0 Participants |
| Post-Operative to 3 Months | Use of Narcotics Post-surgery | Back Meds | IV or injected narcotics | 0 Participants |
| 3 to 6 Months | Use of Narcotics Post-surgery | Non-Back Meds | Epidural/Facet injections | 0 Participants |
| 3 to 6 Months | Use of Narcotics Post-surgery | Back Meds | Chronic daily short-acting narcotics | 16 Participants |
| 3 to 6 Months | Use of Narcotics Post-surgery | Back Meds | Chronic daily long-acting narcotics | 5 Participants |
| 3 to 6 Months | Use of Narcotics Post-surgery | Back Meds | IV or injected narcotics | 0 Participants |
| 3 to 6 Months | Use of Narcotics Post-surgery | Back Meds | Epidural/Facet injections | 0 Participants |
| 3 to 6 Months | Use of Narcotics Post-surgery | Back Meds | Missing | 0 Participants |
| 3 to 6 Months | Use of Narcotics Post-surgery | Non-Back Meds | None | 81 Participants |
| 3 to 6 Months | Use of Narcotics Post-surgery | Non-Back Meds | Non-narcotics or NSAIDs | 14 Participants |
| 3 to 6 Months | Use of Narcotics Post-surgery | Non-Back Meds | Intermittent short-acting narcotics | 2 Participants |
| 3 to 6 Months | Use of Narcotics Post-surgery | Non-Back Meds | Chronic daily short-acting narcotics | 2 Participants |
| 3 to 6 Months | Use of Narcotics Post-surgery | Non-Back Meds | Missing | 0 Participants |
| 3 to 6 Months | Use of Narcotics Post-surgery | Non-Back Meds | Chronic daily long-acting narcotics | 1 Participants |
| 3 to 6 Months | Use of Narcotics Post-surgery | Non-Back Meds | IV or injected narcotics | 0 Participants |
| 3 to 6 Months | Use of Narcotics Post-surgery | Back Meds | None | 24 Participants |
| 3 to 6 Months | Use of Narcotics Post-surgery | Back Meds | Non-narcotics or NSAIDs | 32 Participants |
| 3 to 6 Months | Use of Narcotics Post-surgery | Back Meds | Intermittent short-acting narcotics | 23 Participants |
| 6 to 12 Months | Use of Narcotics Post-surgery | Back Meds | Chronic daily short-acting narcotics | 12 Participants |
| 6 to 12 Months | Use of Narcotics Post-surgery | Non-Back Meds | None | 64 Participants |
| 6 to 12 Months | Use of Narcotics Post-surgery | Back Meds | Chronic daily long-acting narcotics | 1 Participants |
| 6 to 12 Months | Use of Narcotics Post-surgery | Back Meds | Intermittent short-acting narcotics | 14 Participants |
| 6 to 12 Months | Use of Narcotics Post-surgery | Back Meds | Non-narcotics or NSAIDs | 32 Participants |
| 6 to 12 Months | Use of Narcotics Post-surgery | Non-Back Meds | Chronic daily short-acting narcotics | 0 Participants |
| 6 to 12 Months | Use of Narcotics Post-surgery | Non-Back Meds | Epidural/Facet injections | 0 Participants |
| 6 to 12 Months | Use of Narcotics Post-surgery | Non-Back Meds | IV or injected narcotics | 0 Participants |
| 6 to 12 Months | Use of Narcotics Post-surgery | Non-Back Meds | Intermittent short-acting narcotics | 4 Participants |
| 6 to 12 Months | Use of Narcotics Post-surgery | Non-Back Meds | Non-narcotics or NSAIDs | 25 Participants |
| 6 to 12 Months | Use of Narcotics Post-surgery | Back Meds | Missing | 2 Participants |
| 6 to 12 Months | Use of Narcotics Post-surgery | Non-Back Meds | Chronic daily long-acting narcotics | 0 Participants |
| 6 to 12 Months | Use of Narcotics Post-surgery | Back Meds | None | 34 Participants |
| 6 to 12 Months | Use of Narcotics Post-surgery | Back Meds | IV or injected narcotics | 0 Participants |
| 6 to 12 Months | Use of Narcotics Post-surgery | Non-Back Meds | Missing | 2 Participants |
| 6 to 12 Months | Use of Narcotics Post-surgery | Back Meds | Epidural/Facet injections | 0 Participants |
| 12 to 24+ Months | Use of Narcotics Post-surgery | Back Meds | Chronic daily short-acting narcotics | 7 Participants |
| 12 to 24+ Months | Use of Narcotics Post-surgery | Back Meds | Intermittent short-acting narcotics | 7 Participants |
| 12 to 24+ Months | Use of Narcotics Post-surgery | Back Meds | Chronic daily long-acting narcotics | 3 Participants |
| 12 to 24+ Months | Use of Narcotics Post-surgery | Back Meds | None | 43 Participants |
| 12 to 24+ Months | Use of Narcotics Post-surgery | Back Meds | Epidural/Facet injections | 1 Participants |
| 12 to 24+ Months | Use of Narcotics Post-surgery | Back Meds | IV or injected narcotics | 0 Participants |
| 12 to 24+ Months | Use of Narcotics Post-surgery | Back Meds | Missing | 1 Participants |
| 12 to 24+ Months | Use of Narcotics Post-surgery | Non-Back Meds | Epidural/Facet injections | 0 Participants |
| 12 to 24+ Months | Use of Narcotics Post-surgery | Non-Back Meds | Intermittent short-acting narcotics | 5 Participants |
| 12 to 24+ Months | Use of Narcotics Post-surgery | Non-Back Meds | Missing | 1 Participants |
| 12 to 24+ Months | Use of Narcotics Post-surgery | Non-Back Meds | Chronic daily short-acting narcotics | 3 Participants |
| 12 to 24+ Months | Use of Narcotics Post-surgery | Non-Back Meds | None | 60 Participants |
| 12 to 24+ Months | Use of Narcotics Post-surgery | Back Meds | Non-narcotics or NSAIDs | 23 Participants |
| 12 to 24+ Months | Use of Narcotics Post-surgery | Non-Back Meds | Non-narcotics or NSAIDs | 16 Participants |
| 12 to 24+ Months | Use of Narcotics Post-surgery | Non-Back Meds | Chronic daily long-acting narcotics | 0 Participants |
| 12 to 24+ Months | Use of Narcotics Post-surgery | Non-Back Meds | IV or injected narcotics | 0 Participants |
| Overall | Use of Narcotics Post-surgery | Back Meds | Missing | 2 Participants |
| Overall | Use of Narcotics Post-surgery | Non-Back Meds | None | 36 Participants |
| Overall | Use of Narcotics Post-surgery | Non-Back Meds | Epidural/Facet injections | 0 Participants |
| Overall | Use of Narcotics Post-surgery | Back Meds | Chronic daily long-acting narcotics | 1 Participants |
| Overall | Use of Narcotics Post-surgery | Non-Back Meds | IV or injected narcotics | 0 Participants |
| Overall | Use of Narcotics Post-surgery | Non-Back Meds | Non-narcotics or NSAIDs | 14 Participants |
| Overall | Use of Narcotics Post-surgery | Non-Back Meds | Missing | 2 Participants |
| Overall | Use of Narcotics Post-surgery | Non-Back Meds | Intermittent short-acting narcotics | 0 Participants |
| Overall | Use of Narcotics Post-surgery | Non-Back Meds | Chronic daily short-acting narcotics | 1 Participants |
| Overall | Use of Narcotics Post-surgery | Back Meds | Chronic daily short-acting narcotics | 2 Participants |
| Overall | Use of Narcotics Post-surgery | Back Meds | Non-narcotics or NSAIDs | 19 Participants |
| Overall | Use of Narcotics Post-surgery | Non-Back Meds | Chronic daily long-acting narcotics | 0 Participants |
| Overall | Use of Narcotics Post-surgery | Back Meds | Intermittent short-acting narcotics | 2 Participants |
| Overall | Use of Narcotics Post-surgery | Back Meds | IV or injected narcotics | 0 Participants |
| Overall | Use of Narcotics Post-surgery | Back Meds | Epidural/Facet injections | 0 Participants |
| Overall | Use of Narcotics Post-surgery | Back Meds | None | 27 Participants |