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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

1999-06-30

Study Completion Date

2005-07-31

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.

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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.

Conditions

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Degenerative Lumbar Spondylolisthesis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

autogenous bone graft with the addition of OP-1 Putty

Group Type EXPERIMENTAL

Use of OP-1 Putty in Uninstrumented posterolateral fusion

Intervention Type DEVICE

Use of OP-1 Putty in Uninstrumented posterolateral fusion

2

autogenous bone graft alone

Group Type ACTIVE_COMPARATOR

Use of OP-1 Putty in Uninstrumented posterolateral fusion

Intervention Type DEVICE

Use of OP-1 Putty in Uninstrumented posterolateral fusion

Interventions

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Use of OP-1 Putty in Uninstrumented posterolateral fusion

Intervention Type DEVICE

Other Intervention Names

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Uninstrumented posterolateral fusion

Eligibility Criteria

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Inclusion Criteria

1. 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.
2. The subject is a candidate for decompression and spinal fusion with the use of autograft from the iliac crest.
3. The subject requires one level lumbar fusion (L-3 to S-1).
4. The subject has a preoperative Oswestry Disability Index of 30-100.

Exclusion Criteria

1. The subject has active spinal and/or systemic infection.
2. The subject is morbidly obese.
3. The subject has a known sensitivity to any component of the OP-1 Putty.
4. 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.
5. The subject uses tobacco or nicotine or is prescribed steroids such as cortisone.

Minimum Eligible Age

18 Years

Maximum Eligible Age

81 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No