A Prospective Pilot Study of the OP-1 Putty in Uninstrumented Posterolateral Fusions

Study Overview
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Brief Summary
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This study will explore the use of OP-1 Putty in conjunction with surgical treatment for the treatment of spinal decompression and lumbar spinal fusion.

Detailed Description
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It is postulated that the addition of OP-1 Putty to autogenous bone will prove beneficial in the treatment of patients requiring decompression and lumbar spinal fusion. The Investigational system is intended to stimulate bone growth. It is indicated as an adjunct or a replacement for autograft in spinal fusion.

Official Title
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A Prospective, Randomized, Controlled, Multicenter, Pilot Study of the OP-1 Putty in Uninstrumented Posterolateral Fusions

Conditions
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Degenerative Lumbar Spondylolisthesis

Intervention / Treatment
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* Device: Use of OP-1 Putty in Uninstrumented posterolateral 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: 81 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>autogenous bone graft with the addition of OP-1 Putty | Device: Use of OP-1 Putty in Uninstrumented posterolateral fusion<br>* Use of OP-1 Putty in Uninstrumented posterolateral fusion<br>* Other names: Uninstrumented posterolateral fusion;|
| Active Comparator: 2<br>autogenous bone graft alone | Device: Use of OP-1 Putty in Uninstrumented posterolateral fusion<br>* Use of OP-1 Putty in Uninstrumented posterolateral fusion<br>* Other names: Uninstrumented posterolateral fusion;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety, by comparison of the complications and neurological status within the OP-1treatment groups and the control group (autograft alone). |  | 6 weeks; 3, 6, 9, 12, and 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy, by comparison of overall fusion success and time to fusion along with pain / function outcome within the OP-1 treatment groups and the control group (autograft alone). |  | 6 weeks; 3, 6, 9, 12, and 24 months | 

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