Performance of Inductigraft in Spinal Fusion

Study Overview
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Brief Summary
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This is an open-label non-randomised, prospective, post market study to evaluate the performance of Inductigraft (osteoinductive synthetic bone graft) in patients receiving posterolateral lumbar spine fusion through assessment of successful fusion at 12 months post operation using x-rays and CT scans. Quality of life questionnaires also used to assess clinical outcome measures such as pain and quality of life. Patients followed up for 24 months after surgery.

Official Title
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A Prospective Open-label Non-randomdised Multi-centre Clinical Study to Evaluate the Performance of Inductigraft in Posterolateral Fusion

Conditions
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Degenerative Disk Disease, Spinal Stenosis of Lumbar Region

Intervention / Treatment
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* Device: Inductigraft


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosed with Degenerative Disk Disease (DDD) or lumbar spinal stenosis at one or two continuous spinal level(s), including subjects with spondylolisthesis (i.e. degenerative or isthmic) Has failed at least six months of non-operative treatment prior to clinical trial enrolment and is a candidate for spinal fusion surgery over one or two vertebral levels between, and including, L2 to S1 (i.e. second lumbar to first sacral) ≥ 18 years old and skeletally mature (epiphyses closed) Is, in the Investigator's opinion, psychosocially, mentally, and physically able to fully comply with this protocol, including the post-operative regimen, required follow up visits, the filling out of required forms, and have the ability to understand and give written informed consent. Exclusion Criteria: Has diagnosis of symptomatic DDD, spondylolisthesis, or lumbar spinal stenosis at more than two levels Has had prior fusion surgery at any lumbar level Has systemic infection or infection at the surgical site History of significant metabolic bone disease such as osteomalacia, autoimmune disease including rheumatoid arthritis, renal disease, hepatic disease, peripheral vascular disease, insulin dependent diabetes, Paget's disease at the involved spinal level(s) or upper motor neuron disease (positive Babinski sign) Has a medical condition that would interfere with post-operative assessments and care (i.e. psychiatric disease, paraplegia, quadriplegia, etc.) Is in poor general health or any concurrent disease process that would place the subject in excessive risk to surgery (e.g. significant circulatory, pulmonary problems, or cardiac disease) Has a history (present or past) of substance abuse (recreational drugs, prescription drugs or alcohol) that in the Investigator's opinion may interfere with protocol assessments and/or with the subject's ability to complete the protocol required follow up Is known to be pregnant/breastfeeding at the time of enrollment, or plans to become pregnant during the course of the clinical trial Is participating in, or has completed within the last 30 days, another investigational clinical trial, which could confound results Has had three or more prior decompressive surgeries, or a prior posterior lumbar surgery resulting in significant muscle/ligament morbidity. This does NOT include facet saving techniques such as discectomy, laminotomy, and intradiscal procedures including nucleotomy, IDET procedures or annuloplasty procedures Has back or leg pain of unknown cause Morbid obesity defined as a Body Mass Index (BMI) ≥ 40 Non-discogenic or non-stenotic cause of symptoms (e.g. tumour or fracture at the involved level) Has a condition or requires post-operative medications that may interfere with bone/soft tissue healing (i.e. oral or parenteral glucocorticoids, immunosuppressives, methotrexate, etc.), or that effect the rate of bone metabolism unless they have undergone a 14 day wash out period prior to surgery Is undergoing treatment for osteoporosis (excluding osteopenia) such that in the Investigator's opinion, spinal instrumentation would be contraindicated Is involved in on-going litigation, concerning their medical condition. Has a known allergy to silicon.

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: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Inductigraft<br>open label non randomised to assess performance of synthetic bone graft using the product, Inductigraft, in posterolateral lumbar fusion | Device: Inductigraft<br>* Synthetic bone graft<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fusion rate | Assessed by x-ray and CT scan | 12 months after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fusion rate | fusion rate at 6 and 24 months by x-ray/CT scan | 6 and 24 months after surgery | 
| Clinical Outcome Measure - pain | Assessed by VAS scores | 6, 12 and 24 months | 
| Clinical Outcome measure - Quality of Life | Oswestry Disability Index | 6,12,and 24 months | 
| Clinical Outcome measure - Quality of Life | SF-36 v2 short form, health questionnaire | 6,12,and 24 months | 
| Adverse events | Assessment of Adverse events | 0-24 months after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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inductigraft, osteoinductive, synthetic bone graft, posterolateral lumbar fusion, post market, lumbar spinal stenosis