A Prospective Pilot Study of the OP-1 Putty in Uninstrumented Posterolateral Fusions
This study has been completed.
Sponsor:
Olympus Biotech Corporation
Information provided by:
Olympus Biotech Corporation
ClinicalTrials.gov Identifier:
NCT00679107
First received: May 13, 2008
Last updated: June 9, 2011
Last verified: June 2011
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Degenerative Lumbar Spondylolisthesis |
Device: Use of OP-1 Putty in Uninstrumented posterolateral fusion |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Prospective, Randomized, Controlled, Multicenter, Pilot Study of the OP-1 Putty in Uninstrumented Posterolateral Fusions |
Further study details as provided by Olympus Biotech Corporation:
Primary Outcome Measures:
- Safety, by comparison of the complications and neurological status within the OP-1treatment groups and the control group (autograft alone). [ Time Frame: 6 weeks; 3, 6, 9, 12, and 24 months ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- 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). [ Time Frame: 6 weeks; 3, 6, 9, 12, and 24 months ] [ Designated as safety issue: No ]
| Enrollment: | 48 |
| Study Start Date: | June 1999 |
| Study Completion Date: | July 2005 |
| Primary Completion Date: | December 2000 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
autogenous bone graft with the addition of OP-1 Putty
|
Device: Use of OP-1 Putty in Uninstrumented posterolateral fusion
Use of OP-1 Putty in Uninstrumented posterolateral fusion
Other Name: Uninstrumented posterolateral fusion
|
|
Active Comparator: 2
autogenous bone graft alone
|
Device: Use of OP-1 Putty in Uninstrumented posterolateral fusion
Use of OP-1 Putty in Uninstrumented posterolateral fusion
Other Name: Uninstrumented posterolateral fusion
|
Detailed Description:
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.
Eligibility| Ages Eligible for Study: | 18 Years to 81 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00679107
Locations
| United States, Connecticut | |
| New Haven, Connecticut, United States | |
| United States, Illinois | |
| Chicago, Illinois, United States | |
| United States, Michigan | |
| Royal Oak, Michigan, United States | |
| United States, Ohio | |
| Akron, Ohio, United States | |
| United States, Pennsylvania | |
| Philadelphia, Pennsylvania, United States | |
Sponsors and Collaborators
Olympus Biotech Corporation
More Information
No publications provided
| ClinicalTrials.gov Identifier: | NCT00679107 History of Changes |
| Other Study ID Numbers: | S99-01US |
| Study First Received: | May 13, 2008 |
| Last Updated: | June 9, 2011 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Olympus Biotech Corporation:
|
Degenerative Disc Disease |
Additional relevant MeSH terms:
|
Spondylolisthesis Spondylolysis Spondylosis |
Spinal Diseases Bone Diseases Musculoskeletal Diseases |
ClinicalTrials.gov processed this record on June 18, 2013