OP-1 Putty for Posterolateral Fusions

Study Overview
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Brief Summary
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The trial was designed to demonstrate the comparability of the overall success rate in the OP-1 Putty treatment group to the autograft treatment group.

Detailed Description
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A controlled, open- label, blinded radiographic assessment, randomized, prospective, multicenter, multinational pivotal study in which patients with single level (L3-S1) degenerative lumbar spondylolisthesis (Grade 1 or 2) with spinal stenosis underwent decompression and spinal fusion and received OP-1 Putty or autograft. This study was a one-sided, non- inferiority trial comparing the overall success between the OP-1 Putty group and the control autograft group.

Official Title
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OP-1 Putty for Posterolateral Fusions

Conditions
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Degenerative Lumbar Spondylolisthesis

Intervention / Treatment
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* Procedure: Spinal fusion


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: The subject has a diagnosis of Degenerative Lumbar Spondylolisthesis of Grade I or II with Spinal Stenosis demonstrated by medical history, physical examination a n d radiographic imaging. The subject is a candidate for decompression and spinal fusion with the use of autograft from the iliac crest. The subject requires one level lumbar fusion (L-3 to S-1). The subject has a preoperative Oswestry Disability Index of 30-100. Exclusion Criteria: The subject has active spinal and/or systemic infection. The subject is morbidly obese. The subject has a known sensitivity to any component of the OP-1 Putty. The subject has spinal instability measured on flexion / extension radiographs of greater than 50% translation of the vertebrae and greater than or equal to 20 degrees of angular motion. The subject uses tobacco or nicotine or is prescribed steroids such as cortisone.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>OP-1 Putty | Procedure: Spinal fusion<br>* Surgical procedure for lumbar spinal posterior decompression with concomitant posterolateral intertransverse process arthrodesis<br>* Other names: Lumbar Spinal Fusion;|
| Active Comparator: 2<br>Autograft | Procedure: Spinal fusion<br>* Surgical procedure for lumbar spinal posterior decompression with concomitant posterolateral intertransverse process arthrodesis<br>* Other names: Lumbar Spinal Fusion;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall success rate at 24 months in the OP-1 Putty and the autograft groups, radiographic demonstration of spinal fusion, ODI improvement of at least 20%, no revisions, removals or supplemental fixations |  | 3, 6, 12, 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The number of anticipated and unanticipated complications/AEs that occurred within the study population, Visual Analog Scale Results for Pain Assessment, Donor Site Pain, Medication Use |  | 3, 6, 12, 24 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Degenerative Disc Disease