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Study of OP-1 Putty in Uninstrumented Posterolateral Fusions

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

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 ]

Secondary Outcome Measures:
  • Re-assessments of all clinical parameters from S01-01US [ Time Frame: 3+ years post-treatment from the Pivotal study S01-01US ]

Enrollment: 202
Study Start Date: May 2007
Study Completion Date: August 2007
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

Ages Eligible for Study:   18 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients treated in clinical protocol S01-01US

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
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Please refer to this study by its identifier: NCT00678353

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

Responsible Party: Shinichi Torii, Olympus Biotech Identifier: NCT00678353     History of Changes
Other Study ID Numbers: 06-UPLF-01
Study First Received: May 13, 2008
Last Updated: June 9, 2011

Keywords provided by Olympus Biotech Corporation:
Degenerative disc disease

Additional relevant MeSH terms:
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases processed this record on September 21, 2017