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

This study has been completed.
Sponsor:
Information provided by:
Olympus Biotech Corporation
ClinicalTrials.gov Identifier:
NCT00679107
First received: May 13, 2008
Last updated: June 9, 2011
Last verified: June 2011
  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:

  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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Bone Diseases
Musculoskeletal Diseases
Spinal Diseases
Spondylolysis
Spondylosis

ClinicalTrials.gov processed this record on November 25, 2014