Study of OP-1 Putty in Uninstrumented Posterolateral Fusions

This study has been completed.
Sponsor:
Information provided by:
Olympus Biotech Corporation
ClinicalTrials.gov Identifier:
NCT00678353
First received: May 13, 2008
Last updated: June 9, 2011
Last verified: June 2011
  Purpose

This study is to provide additional data to support the safety and efficacy of OP-1 Putty as a replacement for autograft in patients undergoing posterolateral spinal fusion.


Condition
Degenerative Lumbar Spondylolisthesis

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Prospective Data Collection From the Stryker Biotech Pivotal IDE Study of OP-1 Putty in Uninstrumented Posterolateral Fusions

Further study details as provided by Olympus Biotech Corporation:

Primary Outcome Measures:
  • Evidence of bone by CT scan [ Time Frame: 3+ years post-treatment from the Pivotal study S01-01US ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Re-assessments of all clinical parameters from S01-01US [ Time Frame: 3+ years post-treatment from the Pivotal study S01-01US ] [ Designated as safety issue: No ]

Enrollment: 202
Study Start Date: May 2007
Study Completion Date: August 2007
Groups/Cohorts
1
Follow-up to S01-01US, conducted to expand information

Detailed Description:

Follow-up study 06-UPLF-01 was a prospective collection of longer-term data on the patient population from pivotal study S01-01US, and was conducted to expand the information regarding efficacy, particularly with regard to radiographic assessment of fusion, as well as the longer-term safety of OP-1 Putty in uninstrumented posterolateral fusion (PLF) as compared to autograft

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients treated in clinical protocol S01-01US

Criteria

Inclusion Criteria:

  1. The patient was treated in Stryker Biotech clinical protocol S01-01US (Pivotal IDE study) and not a retreatment failure at the time of completion.
  2. The patient or legal guardian is willing and able to understand, sign and date the study specific Patient Informed Consent.
  3. The patient agrees to complete the necessary clinical and radiographic evaluations.

Exclusion Criteria:

1. There are no exclusion criteria for participation in this protocol.

  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: NCT00678353

  Show 22 Study Locations
Sponsors and Collaborators
Olympus Biotech Corporation
  More Information

No publications provided

Responsible Party: Shinichi Torii, Olympus Biotech
ClinicalTrials.gov Identifier: NCT00678353     History of Changes
Other Study ID Numbers: 06-UPLF-01
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 September 22, 2014