Degenerative Changes, Spondylosis, Stenosis
Conditions
Brief summary
The objective of this study is to prospectively evaluate the performance of Integra's OsteoStrux Collagen Ceramic Scaffold combined with bone marrow aspirate as an adjunct for instrumented posterolateral spine fusion, as compared to local autograft.
Interventions
PROCEDUREPosterolateral Fusion
Sponsors
SeaSpine, Inc.
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Are 18 (eighteen) years of age or older at the time of surgery. 2. Require spinal fusion using TLIF, PLF or PLIF, with or without the use of an interbody spacer, at 1 to 3 levels between L3-S1. 3. Are willing and able to return for the scheduled follow-up visits, follow post-operative instructions and undergo the required radiographic exams (A/P, Lateral Neutral and Lateral Flexion/Extension X-rays) for up to 4 time points between 3 weeks and 12 months post-surgery (3 months ± 2 weeks, 6±1 months, 12±2 months and if required 24±3 months post-surgery), including one CT-scan at 12±2 months. 4. Are unresponsive to conservative care over a period of at least 6 months or have signs and/or symptoms that mandate urgent surgical intervention. 5. Are willing and able to sign study specific informed consent.
Exclusion criteria
1. Are long term users of medications (i.e. steroids greater than 8 days) that are known to inhibit fusion or bone metabolism at any time within 6 months prior to surgery. Exceptions are inhaled steroids for asthma treatment (i.e. patients on inhaled steroids are allowed), or epidural steroid injections. 2. Are taking immunosuppressive agents (Cancer chemotherapy, treatment with Disease Modifying Anti-rheumatic drugs (DMARDs) or any similar immunomodulating drugs) or are treated with Growth Factors or Insulin at any time within 6 months prior to surgery. 3. Are being treated with radiotherapy. 4. Are having medical conditions, known to impact bone metabolism, such as Paget's disease, or has established osteoporosis (i.e. has had one or more fragility fractures). 5. Are pregnant, lactating or women wishing to become pregnant. 6. Are a prisoner. 7. BMI ≥ 40 8. Are smokers and/or nicotine/tobacco users 9. Are currently participating in an investigational drug or another device study that has not completed the primary endpoint or that clinically interferes with the study endpoints. 10. Had prior spine surgery at the index level except posterior decompressive surgery where the posterior elements are preserved e.g. facet saving techniques such as discectomy, laminotomy, and intradiscal procedures. 11. Use of routine prophylactic NSAIDS for 3 months post-operatively, but low dose concomitant pain medications e.g. aspirin should be continued and recorded on the Concomitant Pain Medications case report form (CRF).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Posterolateral Gutters That Have Evidence of Arthrodesis (Fusion) at 3, 6, 12, and 24 Months, as Measured by X-rays. | up to 24 months | Posterolateral fusion study in which each patient undergoes posterolateral fusion. During the posterolateral fusion, each spinal level is treated with two grafts, the symptomatic posterolateral gutter is treated with study arm (OsteoStrux) and the contralateral posterolateral gutter is treated with the control arm (local autograft). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Interbody Fusion as Determined by X-ray at 3, 6, 12 and 24 Months | upto 24 months | NA (Not Applicable): This post-market study was primarily a posterolateral fusion study. Interbody fusion was a secondary endpoint. As interbody fusion was completed per standard of care, transforaminal lumbar interbody fusion (TLIF), posterolateral fusion (PLF), or posterior lumbar interbody fusion (PLIF) with or without the use of an interbody spacer and any graft material could be used per the Investigator discretion. As interbody fusion was indistinguishable per arms, data were not collected due to a limitation in the method of analysis per protocol. Therefore data was not analyzed and outcome is NA. |
| Interbody Fusion as Determined by CT Post-surgery at Available Time-points | 12 months | NA (Not Applicable): This post-market study was primarily a posterolateral fusion study. Interbody fusion was a secondary endpoint. As interbody fusion was completed per standard of care, transforaminal lumbar interbody fusion (TLIF), posterolateral fusion (PLF), or posterior lumbar interbody fusion (PLIF) with or without the use of an interbody spacer and any graft material could be used per the Investigator discretion. As interbody fusion was not a primary endpoint and was indistinguishable per control and study arms, interbody fusion results were not analyzed. |
| EQ-5D Health State Visual Analog Scale (VAS) Questionnaire at All Available Time-points | upto 24 months | EQ-5D is a standardized instrument developed by the EuroQol Group as a measure of health-related quality of life that can be used in a wide range of health conditions and treatments. The EQ-5D consists of a descriptive system and the EQ VAS. The EQ-5D-5l has a descriptive system and the EQ visual analogue scale (EQ VAS).The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels which results in a 1-5 level selected for that dimension. The level when added together describes the patient's health state. The EQ VAS records the patient's self-rated health on a vertical visual analogue scale. Score is 0-100 and a lower score represents a better score. |
| Number of Posterolateral Levels With Correlation of Fusion Ratings by X-ray and CT Scan | 12 months | Correlation of x-ray with computed tomography scan analysis at the 12 month follow-up time point. |
| Number of Posterolateral Gutters Showing Evidence of Arthrodesis (Fusion) as Measured by CT | 12 months | Each posterolateral gutter was assessed for extent of fusion using computed tomography (CT) scan. |
| Medical Outcomes: Worst Leg Pain on the Visual Analog Scale (VAS) at All Available Time-points. | upto 24 months | The visual analogue scale (VAS) is a commonly used outcome measure for research studies. It is presented as a 100-mm horizontal line on which the patient's pain intensity is represented by a point between the extremes of 0/no pain at all and 100/worst pain imaginable. The study in this scale is used for the worst leg pain. A lower score represents a better score. |
| Medical Outcomes: Visual Analog Scale (VAS) Back Pain at All Available Time-points. | upto 24 months | The visual analogue scale (VAS) is a commonly used outcome measure for research studies. It is presented as a 100-mm horizontal line on which the patient's pain intensity is represented by a point between the extremes of 0/no pain at all and 100/worst pain imaginable. The study in this scale is used for back pain. A lower score represents a better score. |
| Medical Outcomes: Maintenance of Lower Extremity Neurological Function at All Available Time-points. | upto 24 months | Posterolateral fusion study in which one spinal level is treated with both the study and control arm. The symptomatic posterolateral spinal side is OsteoStrux and the contralateral posterolateral spinal side is local autograft. NA (Not Applicable): Neurological function data was not able to be analyzed as there was a limitation of the method in the ability to distinguish between posterolateral sides in a neurological function assessment. Neurological function is indistinguishable between the right and left posterolateral sides of the lower extremities using the methods in the protocol. Therefore, this outcomes measure was not applicable. |
| Medical Outcomes: Oswestry Disability Index (ODI), at All Available Time-points. | upto 24 months | The ODI is an index derived from the Oswestry Low Back Pain Questionnaire used by surgeons, clinicians and researchers to quantify disability for low back pain. The questionnaire is self-completed and covers 10 topics about pain intensity, lifting, ability to care for oneself, ability to walk, ability to sit, sexual function, ability to stand, social life, sleep quality, and ability to travel. Scores are from 0-100 and a lower score represents a better score. |
Countries
United States
Participant flow
Recruitment details
Posterolateral fusion study in which each patient undergoes posterolateral fusion. During the posterolateral fusion, each spinal level is treated with two grafts, the symptomatic posterolateral gutter is treated with study arm (OsteoStrux) and the contralateral posterolateral gutter is treated with the control arm (local autograft).
Participants by arm
| Arm | Count |
|---|---|
| All Study Participants Posterolateral fusion study in which each patient undergoes posterolateral fusion. During the posterolateral fusion, each spinal level is treated with two grafts, the symptomatic posterolateral gutter is treated with study arm (OsteoStrux) and the contralateral posterolateral gutter is treated with the control arm (local autograft). | 29 |
| Total | 29 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to Follow-up | 3 |
Baseline characteristics
| Characteristic | All Study Participants |
|---|---|
| Age, Continuous | 57 years |
| Body Mass Index (BMI) | 31.6 kg/m^2 STANDARD_DEVIATION 5 |
| Region of Enrollment United States | 29 Participants |
| Sex: Female, Male Female | 12 Participants |
| Sex: Female, Male Male | 17 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 29 |
| other Total, other adverse events | 3 / 29 |
| serious Total, serious adverse events | 5 / 29 |
Outcome results
Primary
Number of Posterolateral Gutters That Have Evidence of Arthrodesis (Fusion) at 3, 6, 12, and 24 Months, as Measured by X-rays.
Posterolateral fusion study in which each patient undergoes posterolateral fusion. During the posterolateral fusion, each spinal level is treated with two grafts, the symptomatic posterolateral gutter is treated with study arm (OsteoStrux) and the contralateral posterolateral gutter is treated with the control arm (local autograft).
Time frame: up to 24 months
Population: Posterolateral fusion study in which each patient undergoes posterolateral fusion. During the posterolateral fusion, each spinal level is treated with two grafts, the symptomatic posterolateral gutter is treated with study arm (OsteoStrux) and the contralateral posterolateral gutter is treated with the control arm (local autograft).
| Arm | Measure | Group | Value (COUNT_OF_UNITS) |
|---|---|---|---|
| All Patients | Number of Posterolateral Gutters That Have Evidence of Arthrodesis (Fusion) at 3, 6, 12, and 24 Months, as Measured by X-rays. | 3 Month: OsteoStux (symptomatic) | 39 Posterolateral Gutters |
| All Patients | Number of Posterolateral Gutters That Have Evidence of Arthrodesis (Fusion) at 3, 6, 12, and 24 Months, as Measured by X-rays. | 3 Month: Local Autograft (contralateral) | 34 Posterolateral Gutters |
| All Patients | Number of Posterolateral Gutters That Have Evidence of Arthrodesis (Fusion) at 3, 6, 12, and 24 Months, as Measured by X-rays. | 6 Month: OsteoStux (symptomatic) | 42 Posterolateral Gutters |
| All Patients | Number of Posterolateral Gutters That Have Evidence of Arthrodesis (Fusion) at 3, 6, 12, and 24 Months, as Measured by X-rays. | 6 Month : Local Autograft (contralateral) | 36 Posterolateral Gutters |
| All Patients | Number of Posterolateral Gutters That Have Evidence of Arthrodesis (Fusion) at 3, 6, 12, and 24 Months, as Measured by X-rays. | 12 Month: OsteoStux (symptomatic) | 44 Posterolateral Gutters |
| All Patients | Number of Posterolateral Gutters That Have Evidence of Arthrodesis (Fusion) at 3, 6, 12, and 24 Months, as Measured by X-rays. | 12 Month: Local Autograft (contralateral) | 32 Posterolateral Gutters |
| All Patients | Number of Posterolateral Gutters That Have Evidence of Arthrodesis (Fusion) at 3, 6, 12, and 24 Months, as Measured by X-rays. | 24 Month: OsteoStux (symptomatic) | 43 Posterolateral Gutters |
| All Patients | Number of Posterolateral Gutters That Have Evidence of Arthrodesis (Fusion) at 3, 6, 12, and 24 Months, as Measured by X-rays. | 24 Month: Local Autograft (contralateral) | 34 Posterolateral Gutters |
Secondary
EQ-5D Health State Visual Analog Scale (VAS) Questionnaire at All Available Time-points
EQ-5D is a standardized instrument developed by the EuroQol Group as a measure of health-related quality of life that can be used in a wide range of health conditions and treatments. The EQ-5D consists of a descriptive system and the EQ VAS. The EQ-5D-5l has a descriptive system and the EQ visual analogue scale (EQ VAS).The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels which results in a 1-5 level selected for that dimension. The level when added together describes the patient's health state. The EQ VAS records the patient's self-rated health on a vertical visual analogue scale. Score is 0-100 and a lower score represents a better score.
Time frame: upto 24 months
Population: Posterolateral fusion study in which one level is treated with both the study and control arm. One side is OsteoStrux combined with bone marrow aspirate (BMA) and the other side is local autograft combined with BMA. Therefore, all results per patient are the same results. All level results are the same unless specifically indicated, per side.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| All Patients | EQ-5D Health State Visual Analog Scale (VAS) Questionnaire at All Available Time-points | Baseline | 58.8 units on a scale | Standard Deviation 26.2 |
| All Patients | EQ-5D Health State Visual Analog Scale (VAS) Questionnaire at All Available Time-points | 6 Months | 79.2 units on a scale | Standard Deviation 15.6 |
| All Patients | EQ-5D Health State Visual Analog Scale (VAS) Questionnaire at All Available Time-points | 12 Months | 77.4 units on a scale | Standard Deviation 17 |
| All Patients | EQ-5D Health State Visual Analog Scale (VAS) Questionnaire at All Available Time-points | 24 Months | 72.9 units on a scale | Standard Deviation 21.1 |
Secondary
Interbody Fusion as Determined by CT Post-surgery at Available Time-points
NA (Not Applicable): This post-market study was primarily a posterolateral fusion study. Interbody fusion was a secondary endpoint. As interbody fusion was completed per standard of care, transforaminal lumbar interbody fusion (TLIF), posterolateral fusion (PLF), or posterior lumbar interbody fusion (PLIF) with or without the use of an interbody spacer and any graft material could be used per the Investigator discretion. As interbody fusion was not a primary endpoint and was indistinguishable per control and study arms, interbody fusion results were not analyzed.
Time frame: 12 months
Population: NA (Not Applicable): As interbody fusion was not a primary endpoint and was indistinguishable per control and study arms, interbody fusion results were not analyzed.
Secondary
Interbody Fusion as Determined by X-ray at 3, 6, 12 and 24 Months
NA (Not Applicable): This post-market study was primarily a posterolateral fusion study. Interbody fusion was a secondary endpoint. As interbody fusion was completed per standard of care, transforaminal lumbar interbody fusion (TLIF), posterolateral fusion (PLF), or posterior lumbar interbody fusion (PLIF) with or without the use of an interbody spacer and any graft material could be used per the Investigator discretion. As interbody fusion was indistinguishable per arms, data were not collected due to a limitation in the method of analysis per protocol. Therefore data was not analyzed and outcome is NA.
Time frame: upto 24 months
Population: NA (Not Applicable): As interbody fusion was not a primary endpoint and was indistinguishable per control and study arms, interbody fusion results were not analyzed.
Secondary
Medical Outcomes: Maintenance of Lower Extremity Neurological Function at All Available Time-points.
Posterolateral fusion study in which one spinal level is treated with both the study and control arm. The symptomatic posterolateral spinal side is OsteoStrux and the contralateral posterolateral spinal side is local autograft. NA (Not Applicable): Neurological function data was not able to be analyzed as there was a limitation of the method in the ability to distinguish between posterolateral sides in a neurological function assessment. Neurological function is indistinguishable between the right and left posterolateral sides of the lower extremities using the methods in the protocol. Therefore, this outcomes measure was not applicable.
Time frame: upto 24 months
Population: NA (Not Applicable): Neurological function data was not able to be analyzed as there was a limitation of the method in the ability to distinguish between posterolateral sides in a neurological function assessment.
Secondary
Medical Outcomes: Oswestry Disability Index (ODI), at All Available Time-points.
The ODI is an index derived from the Oswestry Low Back Pain Questionnaire used by surgeons, clinicians and researchers to quantify disability for low back pain. The questionnaire is self-completed and covers 10 topics about pain intensity, lifting, ability to care for oneself, ability to walk, ability to sit, sexual function, ability to stand, social life, sleep quality, and ability to travel. Scores are from 0-100 and a lower score represents a better score.
Time frame: upto 24 months
Population: Posterolateral fusion study in which one level is treated with both the study and control arm. One side is OsteoStrux combined with bone marrow aspirate (BMA) and the other side is local autograft combined with BMA. Therefore, all results per patient are the same results. All level results are the same unless specifically indicated, per side.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| All Patients | Medical Outcomes: Oswestry Disability Index (ODI), at All Available Time-points. | Baseline | 50.0 units on a scale | Standard Deviation 17.3 |
| All Patients | Medical Outcomes: Oswestry Disability Index (ODI), at All Available Time-points. | 6 Months | 39.3 units on a scale | Standard Deviation 24.6 |
| All Patients | Medical Outcomes: Oswestry Disability Index (ODI), at All Available Time-points. | 12 Months | 34.6 units on a scale | Standard Deviation 22.7 |
| All Patients | Medical Outcomes: Oswestry Disability Index (ODI), at All Available Time-points. | 24 Months | 33.7 units on a scale | Standard Deviation 25.4 |
Secondary
Medical Outcomes: Visual Analog Scale (VAS) Back Pain at All Available Time-points.
The visual analogue scale (VAS) is a commonly used outcome measure for research studies. It is presented as a 100-mm horizontal line on which the patient's pain intensity is represented by a point between the extremes of 0/no pain at all and 100/worst pain imaginable. The study in this scale is used for back pain. A lower score represents a better score.
Time frame: upto 24 months
Population: Posterolateral fusion study in which one level is treated with both the study and control arm. One side is OsteoStrux combined with bone marrow aspirate (BMA) and the other side is local autograft combined with BMA. Therefore, all results per patient are the same results. All level results are the same unless specifically indicated, per side.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| All Patients | Medical Outcomes: Visual Analog Scale (VAS) Back Pain at All Available Time-points. | 12 Months | 32.3 units on a scale | Standard Deviation 298 |
| All Patients | Medical Outcomes: Visual Analog Scale (VAS) Back Pain at All Available Time-points. | Baseline | 70.2 units on a scale | Standard Deviation 25.5 |
| All Patients | Medical Outcomes: Visual Analog Scale (VAS) Back Pain at All Available Time-points. | 6 Months | 34.7 units on a scale | Standard Deviation 30.9 |
| All Patients | Medical Outcomes: Visual Analog Scale (VAS) Back Pain at All Available Time-points. | 24 Months | 28.1 units on a scale | Standard Deviation 18.5 |
Secondary
Medical Outcomes: Worst Leg Pain on the Visual Analog Scale (VAS) at All Available Time-points.
The visual analogue scale (VAS) is a commonly used outcome measure for research studies. It is presented as a 100-mm horizontal line on which the patient's pain intensity is represented by a point between the extremes of 0/no pain at all and 100/worst pain imaginable. The study in this scale is used for the worst leg pain. A lower score represents a better score.
Time frame: upto 24 months
Population: Posterolateral fusion study in which one level is treated with both the study and control arm. One side is OsteoStrux combined with bone marrow aspirate (BMA) and the other side is local autograft combined with BMA. Therefore, all results per patient are the same results. All level results are the same unless specifically indicated, per side.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| All Patients | Medical Outcomes: Worst Leg Pain on the Visual Analog Scale (VAS) at All Available Time-points. | Baseline | 73.9 units on a scale | Standard Deviation 21.6 |
| All Patients | Medical Outcomes: Worst Leg Pain on the Visual Analog Scale (VAS) at All Available Time-points. | 6 Months | 30.5 units on a scale | Standard Deviation 34 |
| All Patients | Medical Outcomes: Worst Leg Pain on the Visual Analog Scale (VAS) at All Available Time-points. | 12 Months | 29.8 units on a scale | Standard Deviation 34.3 |
| All Patients | Medical Outcomes: Worst Leg Pain on the Visual Analog Scale (VAS) at All Available Time-points. | 24 Months | 24.4 units on a scale | Standard Deviation 30.4 |
Secondary
Number of Posterolateral Gutters Showing Evidence of Arthrodesis (Fusion) as Measured by CT
Each posterolateral gutter was assessed for extent of fusion using computed tomography (CT) scan.
Time frame: 12 months
Population: Posterolateral fusion study in which each patient undergoes posterolateral fusion. During the posterolateral fusion, each spinal level is treated with two grafts, the symptomatic posterolateral gutter is treated with study arm (OsteoStrux) and the contralateral posterolateral gutter is treated with the control arm (local autograft).
| Arm | Measure | Group | Value (COUNT_OF_UNITS) |
|---|---|---|---|
| All Patients | Number of Posterolateral Gutters Showing Evidence of Arthrodesis (Fusion) as Measured by CT | 12 Months: OsteoStrux (symptomatic) | 39 Posterolateral gutters |
| All Patients | Number of Posterolateral Gutters Showing Evidence of Arthrodesis (Fusion) as Measured by CT | 12 Months: Local Autograft (contralateral) | 32 Posterolateral gutters |
Secondary
Number of Posterolateral Levels With Correlation of Fusion Ratings by X-ray and CT Scan
Correlation of x-ray with computed tomography scan analysis at the 12 month follow-up time point.
Time frame: 12 months
| Arm | Measure | Group | Value (COUNT_OF_UNITS) |
|---|---|---|---|
| All Patients | Number of Posterolateral Levels With Correlation of Fusion Ratings by X-ray and CT Scan | OsteoStrux (symptomatic): Agree | 37 Posterolateral Gutters |
| All Patients | Number of Posterolateral Levels With Correlation of Fusion Ratings by X-ray and CT Scan | OsteoStrux (symptomatic): Disagree | 3 Posterolateral Gutters |
| All Patients | Number of Posterolateral Levels With Correlation of Fusion Ratings by X-ray and CT Scan | Local Autograft (contralateral): Agree | 32 Posterolateral Gutters |
| All Patients | Number of Posterolateral Levels With Correlation of Fusion Ratings by X-ray and CT Scan | Local Autograft (contralateral): Disagree | 8 Posterolateral Gutters |