Degenerative Disc Disease
Conditions
Brief summary
The purpose of this study is to evaluate the safety and effectiveness of the investigational implant (INFUSE® Bone Graft/PEEK Interbody Spacer/Anterior Cervical Plate) as a method of facilitating spinal fusion at a single level from C3-C7 in patients with symptomatic cervical degenerative disc disease.
Detailed description
This pivotal clinical trial is being conducted to evaluate the safety and effectiveness of INFUSE® Bone Graft with the PEEK Interbody Spacer and Anterior Cervical Plate in patients with symptomatic cervical degenerative disc disease (DDD). The implant under investigation in this clinical trial is INFUSE® Bone Graft, the PEEK Interbody Spacer, and Anterior Cervical Plate. The device will be implanted using an anterior surgical approach. Safety and effectiveness data for patients in this study will be compared to that of historical controls. Historical control data will be taken from the control arms of the following Medtronic studies: (1) the Artificial Cervical Disc (also known as PRESTIGE® Cervical Disc System) pivotal IDE trial (NCT00642876) and (2) the BRYAN® Cervical Disc System pivotal IDE trial (NCT00437190).
Interventions
DEVICEINFUSE® Bone Graft/PEEK Spacer/Anterior Cervical Plate
All patients enrolled in this study will receive the investigational device.
Sponsors
Medtronic Spinal and Biologics
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* INCLUSION: 1. Single-level cervical degenerative disc disease (from C3-C7) requiring surgical treatment and involving intractable radiculopathy and/or myelopathy. 2. Herniated disc and/or osteophyte formation at the level to be treated that is producing symptomatic nerve root and/or spinal cord compression. 3. Unresponsive to non-operative treatment for six weeks or has the presence of progressive symptoms or signs of nerve root/spinal cord compression in the face of continued non-operative management. 4. At least 18 years of age and skeletally mature at the time of surgery. 5. A preoperative Neck Disability Index (NDI) score ≥30. 6. A preoperative neck pain score (pain intensity + pain frequency) ≥8 (out of 20) based on the preoperative Neck and Arm Pain Questionnaire. 7. If a female of childbearing potential, patient is not pregnant or nursing and agrees not to become pregnant for one year following surgery. 8. Is willing and able to comply with the study plan and able to understand and sign the Patient Informed Consent Form.
Exclusion criteria
* EXCLUSION: 1. A cervical spinal condition other than symptomatic cervical degenerative disc disease requiring surgical treatment at the involved level. 2. Documented or diagnosed cervical instability at the target level, defined by dynamic (flexion/extension) radiographs. 3. Previous surgical intervention at the involved level. 4. Any subsequent planned/staged surgical procedure at the involved or adjacent level(s). 5. Fused level adjacent to the level to be treated. 6. Severe pathology of the facet joints of the involved vertebral bodies. 7. Has osteoporosis, osteopenia, or osteomalacia as determined by DEXA scan. 8. Presence of active malignancy or prior history of malignancy (except for basal cell carcinoma of the skin). 9. Overt or active bacterial infection, either local or systemic. 10. Insulin dependent diabetes. 11. Chronic or acute renal failure or prior history of renal disease. 12. Documented allergy or intolerance to stainless steel, titanium, titanium alloy, polyetheretherketone (PEEK), or tantalum. 13. Is mentally incompetent. (if questionable, obtain psychiatric consult.) 14. Is a prisoner. 15. Is an alcohol and/or drug abuser as defined by currently undergoing treatment for alcohol and/or drug abuse. 16. On oral or injectable steroids for 6 weeks or more at the time of enrollment. 17. A history of autoimmune disease. 18. History of exposure to injectable collagen or silicone implants. 19. History of hypersensitivity to protein pharmaceuticals (monoclonal antibodies or gamma globulins) or collagen. 20. Received any previous exposure to any/all BMPs either human or animal extraction. 21. History of allergy to bovine products. 22. History of any allergy resulting in anaphylaxis. 23. History of an endocrine or metabolic disorder known to affect osteogenesis (e.g., Paget's Disease, renal osteodystrophy, Ehlers-Danlos Syndrome, or osteogenesis imperfecta). 24. Condition that requires postoperative medications that interfere with the stability of the implant, such as steroids. 25. Received treatment with an investigational therapy (drug, device, or biologic) within 28 days prior to implantation surgery or such treatment is planned during the 24-month period following the study surgery.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of Overall Success | 24 months post-operation | Rate of overall success is reported as the percentage of participants who met all of the following criteria: 1. fusion at the treated level; 2. pain/disability (Neck Disability Index) success; 3. neurological status success; 4. no serious adverse event classified as implant associated or implant/surgical procedure associated; 5. no additional surgical procedure classified as a failure. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Patients Who Had Secondary Surgeries at the Index Level | 24 months post-operation | Secondary surgical procedures at the index level included revisions, removal, supplemental fixation and reoperations. |
| Arm Pain Success Rate | 24 months post-operation | Arm pain success rate is reported as the percentage of participants whose arm pain improvement met: Preoperative Score - Postoperative Score \> 0. |
| Success Rate of SF-36 PCS | 24 months post-operation | Success rate of SF-36 Health Survey include two components: the success rate of a physical component summary (PCS) and the success rate of a mental component summary (MCS). The success rate of SF-36 PCS was defined as: Post Score - Pre Score \>= 0. |
| Success Rate of SF-36 MCS | 24 months post-operation | Success rate of SF-36 Health Survey include two components: the success rate of a physical component summary (PCS) and the success rate of a mental component summary (MCS). The success rates of SF-36 MCS were defined as: Post Score - Pre Score \>= 0. |
| Operative Time | Time of operation, approximately 1.5 hrs. | Operative time was recorded from skin incision to wound closure. |
| Blood Loss | During the time of operation, approximately 1.5 hours. | — |
| Hospital Stay | During the time of hospital stay, average of 1 day. | — |
| Success Rate of Fusion | 24 months post-operation | Success Rate of Fusion is reported as percent of participants who met the following fusion criteria: 1. Evidence of bridging bone. This is based on the evidence of a continuous bony connection from the superior vertebral body to the inferior vertebral body in at least one of the following areas: lateral, anterior, posterior and/or through the PEEK spacer. 2. No evidence of radiolucency at greater than 50% of the superior or inferior PEEK spacer-vertebra interface. 3. No evidence of motion as defined by ≤ 4º of angular motion (based on flexion-extension lateral plain radiographs). |
| Success Rate of Neck Disability Index | 24 months post-operation | Success rate of Neck Disability Index is reported as the percentage of participants whose neck disability index score met: Pre-treatment Score - Post-treatment Score ≥ 15. |
| Success Rate of Neurological Status | 24 months post-operation | Success rate of neurological status is reported as the percentage of participants who met neurological success defined as maintenance or improvement in all sections (motor, sensory, and reflexes) for the time period evaluated. In order for a section to be considered a success, each element in the section must remain the same or improve from the time of the preoperative evaluation to the time period evaluated. |
| Neck Pain Success Rate | 24 months post-operation | Neck pain success rate is reported as the percentage of participants whose neck pain improvement met: Preoperative Score - Postoperative Score \> 0. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Neck Pain Score | 24 months post-operation | Numerical rating scales are used to evaluate neck pain intensity and frequency. Patients rate their neck pain intensity on a scale from 0-10, with a score of 0 representing no pain and a score of 10 representing pain as bad as it could be. Similarly, patients record their neck pain frequency on a scale from 0-10, with a score of 0 being pain none of the time and a score of 10 being pain all of the time. The total neck pain score is the sum of pain intensity and frequency scores. |
| Arm Pain Score | 24 months post-operation | Numerical rating scales are used to evaluate arm pain intensity and frequency. Patients rate their arm pain intensity on a scale from 0-10, with a score of 0 representing no pain and a score of 10 representing pain as bad as it could be. Similarly, patients record their arm pain frequency on a scale from 0-10, with a score of 0 being pain none of the time and a score of 10 being pain all of the time. The total arm pain score will be the sum of pain intensity and frequency scores. |
| General Health Status -- SF-36 PCS | 24 months post-operation | The Medical Outcomes Study 36-Item Short Form Health Survey (SF-36) was used to assess general health status. The SF-36 results are summarized into two components, a physical component summary (PCS) and a mental component summary (MCS). The score for PCS is between 0 and 100, with higher scores denoting better quality of life. |
| General Health Status -- SF-36 MCS | 24 months post-operation | The Medical Outcomes Study 36-Item Short Form Health Survey (SF-36) was used to assess general health status. The SF-36 results are summarized into two components, a physical component summary (PCS) and a mental component summary (MCS). The score for MCS is between 0 and 100, with higher scores denoting better quality of life. |
| Ossification in the Region of Target Level | 24 months post-operation | Ossification in the region of target level is reported as the percentage of the patients who had ossification in the region of the target level. The region of target level included the index level, the superior and inferior adjacent disc spaces, and the superior and inferior adjacent vertebral bodies. |
| Neck Disability Index Score | 24 months post-operation | The self-administered Neck Disability Index (NDI) Questionnaire was used to assess patient neck pain and ability to function. The NDI scale ranges from 0-100. The best score is 0 (no disability) and worst is 100 (maximum disability). |
Countries
United States
Participant flow
Recruitment details
Five subjects in investigational group and 4 subjects in control group died within 24 months postoperatively. Among them, however, one investigational subject who died at 20 months and one control subject who died at 23 months reported some data that were included as the 24-month evaluation. Thus, they were counted as evaluated at 24 months.
Participants by arm
| Arm | Count |
|---|---|
| INFUSE® Bone Graft In this arm, patients received implant with INFUSE® Bone Graft/PEEK Spacer/Anterior Cervical Plate. | 224 |
| Historical Control Historical control was pooled from the control arms of the following Medtronic studies: (1) the Artificial Cervical Disc (also known as PRESTIGE® Cervical Disc System) pivotal IDE trial (NCT00642876) and (2) the BRYAN® Cervical Disc System pivotal IDE trial (NCT00437190). | 486 |
| Total | 710 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Death | 4 | 3 |
| Overall Study | Lost to Follow-up | 32 | 61 |
Baseline characteristics
| Characteristic | Historical Control | Total | INFUSE® Bone Graft |
|---|---|---|---|
| Age Continuous | 44.2 years STANDARD_DEVIATION 8.7 | 45.0 years STANDARD_DEVIATION 9.3 | 46.8 years STANDARD_DEVIATION 10.2 |
| Alcohol Used No | 336 participants | 449 participants | 113 participants |
| Alcohol Used Yes | 150 participants | 261 participants | 111 participants |
| Education Level < high School | 29 participants | 39 participants | 10 participants |
| Education Level > high School | 314 participants | 448 participants | 134 participants |
| Education Level High School | 142 participants | 222 participants | 80 participants |
| Height | 67.5 in. STANDARD_DEVIATION 4 | 67.5 in. STANDARD_DEVIATION 4.1 | 67.5 in. STANDARD_DEVIATION 4.2 |
| Marital Status Divorced | 44 participants | 65 participants | 21 participants |
| Marital Status Married | 373 participants | 536 participants | 163 participants |
| Marital Status Separated | 4 participants | 11 participants | 7 participants |
| Marital Status Single | 61 participants | 91 participants | 30 participants |
| Marital Status Widowed | 4 participants | 7 participants | 3 participants |
| Preop Work Status No | 176 participants | 247 participants | 71 participants |
| Preop Work Status Yes | 309 participants | 462 participants | 153 participants |
| Race/Ethnicity, Customized Asian | 4 participants | 6 participants | 2 participants |
| Race/Ethnicity, Customized Black | 18 participants | 38 participants | 20 participants |
| Race/Ethnicity, Customized Caucasian | 447 participants | 645 participants | 198 participants |
| Race/Ethnicity, Customized Hispanic | 13 participants | 16 participants | 3 participants |
| Race/Ethnicity, Customized Other | 4 participants | 5 participants | 1 participants |
| Sex: Female, Male Female | 251 Participants | 369 Participants | 118 Participants |
| Sex: Female, Male Male | 235 Participants | 341 Participants | 106 Participants |
| Tobacco Used No | 341 participants | 498 participants | 157 participants |
| Tobacco Used Yes | 145 participants | 211 participants | 66 participants |
| Unresolved Spinal Litigation No | 448 participants | 644 participants | 196 participants |
| Unresolved Spinal Litigation Yes | 38 participants | 66 participants | 28 participants |
| Weight | 182.5 lbs. STANDARD_DEVIATION 40.4 | 184.5 lbs. STANDARD_DEVIATION 41.5 | 188.8 lbs. STANDARD_DEVIATION 43.6 |
| Worker's Compensation No | 440 participants | 659 participants | 219 participants |
| Worker's Compensation Yes | 46 participants | 51 participants | 5 participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 186 / 224 | 371 / 486 |
| serious Total, serious adverse events | 71 / 224 | 159 / 486 |
Outcome results
Primary
Rate of Overall Success
Rate of overall success is reported as the percentage of participants who met all of the following criteria: 1. fusion at the treated level; 2. pain/disability (Neck Disability Index) success; 3. neurological status success; 4. no serious adverse event classified as implant associated or implant/surgical procedure associated; 5. no additional surgical procedure classified as a failure.
Time frame: 24 months post-operation
Population: Primary dataset (including all subjects who received study devices. Missing observations were not imputed.)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| INFUSE® Bone Graft | Rate of Overall Success | 80.9 percentage of participants |
| Historical Control | Rate of Overall Success | 59.9 percentage of participants |
p-value: <0.001Regression, Logistic
Comparison: Superiority comparison of success rates in two treatment groups was a secondary objective of this trial. Superiority analysis was performed if non-inferiority was demonstrated.p-value: <0.001Regression, Logistic
Secondary
Arm Pain Success Rate
Arm pain success rate is reported as the percentage of participants whose arm pain improvement met: Preoperative Score - Postoperative Score \> 0.
Time frame: 24 months post-operation
Population: Primary dataset.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| INFUSE® Bone Graft | Arm Pain Success Rate | 90.9 percentage of participants |
| Historical Control | Arm Pain Success Rate | 88.6 percentage of participants |
p-value: <0.001Regression, Logistic
Comparison: Superiority analysis was performed if non-inferiority was demonstrated.p-value: 0.017Regression, Logistic
Secondary
Blood Loss
Time frame: During the time of operation, approximately 1.5 hours.
Population: Primary dataset.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| INFUSE® Bone Graft | Blood Loss | 40.1 ml | Standard Deviation 54.1 |
| Historical Control | Blood Loss | 58.4 ml | Standard Deviation 59.9 |
p-value: <0.001ANCOVA
Secondary
Hospital Stay
Time frame: During the time of hospital stay, average of 1 day.
Population: Primary dataset.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| INFUSE® Bone Graft | Hospital Stay | 1.0 days | Standard Deviation 0.7 |
| Historical Control | Hospital Stay | 1.0 days | Standard Deviation 0.6 |
p-value: 0.341ANCOVA
Secondary
Neck Pain Success Rate
Neck pain success rate is reported as the percentage of participants whose neck pain improvement met: Preoperative Score - Postoperative Score \> 0.
Time frame: 24 months post-operation
Population: Primary dataset.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| INFUSE® Bone Graft | Neck Pain Success Rate | 96.0 percentage of participants |
| Historical Control | Neck Pain Success Rate | 92.7 percentage of participants |
p-value: 0.001Regression, Logistic
Comparison: Superiority analysis was performed if non-inferiority was demonstrated.p-value: 0.414Regression, Logistic
Secondary
Number of Patients Who Had Secondary Surgeries at the Index Level
Secondary surgical procedures at the index level included revisions, removal, supplemental fixation and reoperations.
Time frame: 24 months post-operation
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| INFUSE® Bone Graft | Number of Patients Who Had Secondary Surgeries at the Index Level | 6 participants |
| Historical Control | Number of Patients Who Had Secondary Surgeries at the Index Level | 27 participants |
p-value: 0.479Regression, Cox
Secondary
Operative Time
Operative time was recorded from skin incision to wound closure.
Time frame: Time of operation, approximately 1.5 hrs.
Population: Primary dataset.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| INFUSE® Bone Graft | Operative Time | 1.0 hrs | Standard Deviation 0.5 |
| Historical Control | Operative Time | 1.4 hrs | Standard Deviation 0.6 |
p-value: <0.001ANCOVA
Secondary
Success Rate of Fusion
Success Rate of Fusion is reported as percent of participants who met the following fusion criteria: 1. Evidence of bridging bone. This is based on the evidence of a continuous bony connection from the superior vertebral body to the inferior vertebral body in at least one of the following areas: lateral, anterior, posterior and/or through the PEEK spacer. 2. No evidence of radiolucency at greater than 50% of the superior or inferior PEEK spacer-vertebra interface. 3. No evidence of motion as defined by ≤ 4º of angular motion (based on flexion-extension lateral plain radiographs).
Time frame: 24 months post-operation
Population: Primary dataset.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| INFUSE® Bone Graft | Success Rate of Fusion | 99.4 percentage of participants |
| Historical Control | Success Rate of Fusion | 87.2 percentage of participants |
p-value: <0.001Regression, Logistic
Comparison: Superiority analysis was performed if non-inferiority was demonstrated.p-value: 0.002Regression, Logistic
Secondary
Success Rate of Neck Disability Index
Success rate of Neck Disability Index is reported as the percentage of participants whose neck disability index score met: Pre-treatment Score - Post-treatment Score ≥ 15.
Time frame: 24 months post-operation
Population: Primary dataset.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| INFUSE® Bone Graft | Success Rate of Neck Disability Index | 85.8 percentage of participants |
| Historical Control | Success Rate of Neck Disability Index | 79.9 percentage of participants |
p-value: <0.001Regression, Logistic
Comparison: Superiority analysis was performed if non-inferiority was demonstrated.p-value: 0.011Regression, Logistic
Secondary
Success Rate of Neurological Status
Success rate of neurological status is reported as the percentage of participants who met neurological success defined as maintenance or improvement in all sections (motor, sensory, and reflexes) for the time period evaluated. In order for a section to be considered a success, each element in the section must remain the same or improve from the time of the preoperative evaluation to the time period evaluated.
Time frame: 24 months post-operation
Population: Primary dataset.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| INFUSE® Bone Graft | Success Rate of Neurological Status | 93.8 percentage of participants |
| Historical Control | Success Rate of Neurological Status | 85.0 percentage of participants |
p-value: <0.001Regression, Logistic
Comparison: Superiority analysis was performed if non-inferiority was demonstrated.p-value: <0.001Regression, Logistic
Secondary
Success Rate of SF-36 MCS
Success rate of SF-36 Health Survey include two components: the success rate of a physical component summary (PCS) and the success rate of a mental component summary (MCS). The success rates of SF-36 MCS were defined as: Post Score - Pre Score \>= 0.
Time frame: 24 months post-operation
Population: Primary dataset.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| INFUSE® Bone Graft | Success Rate of SF-36 MCS | 75.0 percentage of participants |
| Historical Control | Success Rate of SF-36 MCS | 71.3 percentage of participants |
p-value: <0.001Regression, Logistic
Comparison: Superiority analysis was performed if non-inferiority was demonstrated.p-value: 0.133Regression, Logistic
Secondary
Success Rate of SF-36 PCS
Success rate of SF-36 Health Survey include two components: the success rate of a physical component summary (PCS) and the success rate of a mental component summary (MCS). The success rate of SF-36 PCS was defined as: Post Score - Pre Score \>= 0.
Time frame: 24 months post-operation
Population: Primary dataset.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| INFUSE® Bone Graft | Success Rate of SF-36 PCS | 89.8 percentage of participants |
| Historical Control | Success Rate of SF-36 PCS | 88.2 percentage of participants |
p-value: 0.003Regression, Logistic
Comparison: Superiority analysis was performed if non-inferiority was demonstrated.p-value: 0.466Regression, Logistic
Other Pre-specified
Arm Pain Score
Numerical rating scales are used to evaluate arm pain intensity and frequency. Patients rate their arm pain intensity on a scale from 0-10, with a score of 0 representing no pain and a score of 10 representing pain as bad as it could be. Similarly, patients record their arm pain frequency on a scale from 0-10, with a score of 0 being pain none of the time and a score of 10 being pain all of the time. The total arm pain score will be the sum of pain intensity and frequency scores.
Time frame: 24 months post-operation
Population: Primary dataset.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| INFUSE® Bone Graft | Arm Pain Score | Arm pain at baseline | 13.5 units on a scale | Standard Deviation 5.1 |
| INFUSE® Bone Graft | Arm Pain Score | Arm pain at 24 months | 3.6 units on a scale | Standard Deviation 4.9 |
| INFUSE® Bone Graft | Arm Pain Score | Arm pain change at 24 months from baseline | -10.1 units on a scale | Standard Deviation 6.3 |
| Historical Control | Arm Pain Score | Arm pain at baseline | 14.8 units on a scale | Standard Deviation 4.7 |
| Historical Control | Arm Pain Score | Arm pain at 24 months | 4.7 units on a scale | Standard Deviation 5.8 |
| Historical Control | Arm Pain Score | Arm pain change at 24 months from baseline | -10.1 units on a scale | Standard Deviation 6.9 |
p-value: 0.031ANCOVA
Other Pre-specified
General Health Status -- SF-36 MCS
The Medical Outcomes Study 36-Item Short Form Health Survey (SF-36) was used to assess general health status. The SF-36 results are summarized into two components, a physical component summary (PCS) and a mental component summary (MCS). The score for MCS is between 0 and 100, with higher scores denoting better quality of life.
Time frame: 24 months post-operation
Population: Primary dataset.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| INFUSE® Bone Graft | General Health Status -- SF-36 MCS | SF-36 MCS at baseline | 43.6 units on a scale | Standard Deviation 12 |
| INFUSE® Bone Graft | General Health Status -- SF-36 MCS | SF-36 MCS at 24 months | 51.8 units on a scale | Standard Deviation 9.5 |
| INFUSE® Bone Graft | General Health Status -- SF-36 MCS | SF-36 MCS Change at 24 months from baseline | 8.0 units on a scale | Standard Deviation 12 |
| Historical Control | General Health Status -- SF-36 MCS | SF-36 MCS at baseline | 43.6 units on a scale | Standard Deviation 12.1 |
| Historical Control | General Health Status -- SF-36 MCS | SF-36 MCS at 24 months | 50.9 units on a scale | Standard Deviation 10.8 |
| Historical Control | General Health Status -- SF-36 MCS | SF-36 MCS Change at 24 months from baseline | 7.2 units on a scale | Standard Deviation 13.4 |
p-value: 0.189ANCOVA
Other Pre-specified
General Health Status -- SF-36 PCS
The Medical Outcomes Study 36-Item Short Form Health Survey (SF-36) was used to assess general health status. The SF-36 results are summarized into two components, a physical component summary (PCS) and a mental component summary (MCS). The score for PCS is between 0 and 100, with higher scores denoting better quality of life.
Time frame: 24 months post-operation
Population: Primary dataset.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| INFUSE® Bone Graft | General Health Status -- SF-36 PCS | SF-36 PCS at baseline | 31.6 units on a scale | Standard Deviation 6.6 |
| INFUSE® Bone Graft | General Health Status -- SF-36 PCS | SF-36 PCS at 24 months | 47.7 units on a scale | Standard Deviation 11.1 |
| INFUSE® Bone Graft | General Health Status -- SF-36 PCS | SF-36 PCS change at 24 months from baseline | 15.6 units on a scale | Standard Deviation 10.9 |
| Historical Control | General Health Status -- SF-36 PCS | SF-36 PCS at baseline | 31.9 units on a scale | Standard Deviation 7.3 |
| Historical Control | General Health Status -- SF-36 PCS | SF-36 PCS at 24 months | 45.3 units on a scale | Standard Deviation 11.5 |
| Historical Control | General Health Status -- SF-36 PCS | SF-36 PCS change at 24 months from baseline | 13.1 units on a scale | Standard Deviation 11.2 |
p-value: 0.03ANCOVA
Other Pre-specified
Neck Disability Index Score
The self-administered Neck Disability Index (NDI) Questionnaire was used to assess patient neck pain and ability to function. The NDI scale ranges from 0-100. The best score is 0 (no disability) and worst is 100 (maximum disability).
Time frame: 24 months post-operation
Population: Primary dataset.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| INFUSE® Bone Graft | Neck Disability Index Score | NDI at baseline | 50.2 units on a scale | Standard Deviation 14.3 |
| INFUSE® Bone Graft | Neck Disability Index Score | NDI at 24 months | 14.6 units on a scale | Standard Deviation 17.1 |
| INFUSE® Bone Graft | Neck Disability Index Score | NDI change at 24 months from baseline | -34.9 units on a scale | Standard Deviation 17.3 |
| Historical Control | Neck Disability Index Score | NDI at baseline | 53.5 units on a scale | Standard Deviation 16.2 |
| Historical Control | Neck Disability Index Score | NDI at 24 months | 20.9 units on a scale | Standard Deviation 16 |
| Historical Control | Neck Disability Index Score | NDI change at 24 months from baseline | -32.3 units on a scale | Standard Deviation 20.9 |
p-value: 0.002ANCOVA
Other Pre-specified
Neck Pain Score
Numerical rating scales are used to evaluate neck pain intensity and frequency. Patients rate their neck pain intensity on a scale from 0-10, with a score of 0 representing no pain and a score of 10 representing pain as bad as it could be. Similarly, patients record their neck pain frequency on a scale from 0-10, with a score of 0 being pain none of the time and a score of 10 being pain all of the time. The total neck pain score is the sum of pain intensity and frequency scores.
Time frame: 24 months post-operation
Population: Primary dataset.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| INFUSE® Bone Graft | Neck Pain Score | Neck pain at baseline | 15.9 units on a scale | Standard Deviation 2.7 |
| INFUSE® Bone Graft | Neck Pain Score | Neck pain at 24 months | 4.5 units on a scale | Standard Deviation 5.2 |
| INFUSE® Bone Graft | Neck Pain Score | Neck pain change at 24 months from baseline | -11.2 units on a scale | Standard Deviation 5.3 |
| Historical Control | Neck Pain Score | Neck pain at baseline | 15.8 units on a scale | Standard Deviation 3.8 |
| Historical Control | Neck Pain Score | Neck pain at 24 months | 6.0 units on a scale | Standard Deviation 6.9 |
| Historical Control | Neck Pain Score | Neck pain change at 24 months from baseline | -9.8 units on a scale | Standard Deviation 7.2 |
p-value: 0.063ANCOVA
Other Pre-specified
Ossification in the Region of Target Level
Ossification in the region of target level is reported as the percentage of the patients who had ossification in the region of the target level. The region of target level included the index level, the superior and inferior adjacent disc spaces, and the superior and inferior adjacent vertebral bodies.
Time frame: 24 months post-operation
Population: Primary dataset.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| INFUSE® Bone Graft | Ossification in the Region of Target Level | Preoperative (n=220, 442) | 40.9 percentage of participants |
| INFUSE® Bone Graft | Ossification in the Region of Target Level | 24 months (n=168, 407) | 78.6 percentage of participants |
| Historical Control | Ossification in the Region of Target Level | Preoperative (n=220, 442) | 36.9 percentage of participants |
| Historical Control | Ossification in the Region of Target Level | 24 months (n=168, 407) | 59.2 percentage of participants |
Comparison: Statistical analysis at 24 months postoperation.p-value: <0.001Regression, Logistic