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OP-1 Putty for Posterolateral Fusions

This study has been completed.
Sponsor:
Information provided by:
Olympus Biotech Corporation
ClinicalTrials.gov Identifier:
NCT00677950
First received: May 13, 2008
Last updated: June 9, 2011
Last verified: June 2011
History of Changes
  Purpose

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.


Condition Intervention
Degenerative Lumbar Spondylolisthesis
 Procedure: Spinal fusion

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: OP-1 Putty for Posterolateral Fusions

Further study details as provided by Olympus Biotech Corporation:

Primary Outcome Measures:
  • 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 [ Time Frame: 3, 6, 12, 24 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 [ Time Frame: 3, 6, 12, 24 months ] [ Designated as safety issue: No ]

Enrollment: 336
Study Start Date: October 2001
Study Completion Date: November 2005
Primary Completion Date: November 2003 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
OP-1 Putty
 Procedure: Spinal fusion
Surgical procedure for lumbar spinal posterior decompression with concomitant posterolateral intertransverse process arthrodesis
Other Name: Lumbar Spinal Fusion
Active Comparator: 2
Autograft
 Procedure: Spinal fusion
Surgical procedure for lumbar spinal posterior decompression with concomitant posterolateral intertransverse process arthrodesis
Other Name: Lumbar Spinal Fusion

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years to 85 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00677950

  Show 24 Study Locations
Sponsors and Collaborators
Olympus Biotech Corporation
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00677950     History of Changes
Other Study ID Numbers: S01-01US
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