OsteoStrux™ Collagen Ceramic Scaffold in Instrumented Lumbar Spine Fusion

Study Overview
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Brief Summary
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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.

Official Title
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Efficacy and Safety of OsteoStrux™ Collagen Ceramic Scaffold in Instrumented Lumbar Spine Fusion

Conditions
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Degenerative Changes, Stenosis, Spondylosis

Intervention / Treatment
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* Procedure: Posterolateral Fusion


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Are 18 (eighteen) years of age or older at the time of surgery. 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. 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. Are unresponsive to conservative care over a period of at least 6 months or have signs and/or symptoms that mandate urgent surgical intervention. Are willing and able to sign study specific informed consent. Exclusion Criteria: 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. 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. Are being treated with radiotherapy. 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). Are pregnant, lactating or women wishing to become pregnant. Are a prisoner. BMI ≥ 40 Are smokers and/or nicotine/tobacco users 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. 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. 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).

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: OsteoStrux Collagen Ceramic Scaffold<br>OsteoStrux Collagen Ceramic Scaffold (posterolateral gutter at the symptomatic side) | Procedure: Posterolateral Fusion<br> <br> |
| Active Comparator: Local autograft<br>Local autograft (posterolateral gutter at the contralateral side) | Procedure: Posterolateral Fusion<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | up to 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 12 months | 
| 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. | upto 24 months | 
| 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. | 12 months | 
| 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. | upto 24 months | 
| 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. | 12 months | 
| 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. | upto 24 months | 
| 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. | upto 24 months | 
| 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. | upto 24 months | 
| 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. | upto 24 months |