Study of OP-1 Putty in Uninstrumented Posterolateral Fusions - Full Text View

Sponsored by:	Stryker Biotech
Information provided by:	Stryker Biotech
ClinicalTrials.gov Identifier:	NCT00678353

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

U.S. FDA Resources

Study Type:	Observational
Study Design:	Case-Only, 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 Stryker Biotech:

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 ]

Biospecimen Retention: None Retained

Biospecimen Description:

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:

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00678353

Show 22 Study Locations

Sponsors and Collaborators

Stryker Biotech

Investigators

Study Director:

Monique Duncan

Stryker Biotech

More Information

Responsible Party:	Stryker Biotech ( Monique Duncan )
Study ID Numbers:	06-UPLF-01
Study First Received:	May 13, 2008
Last Updated:	November 7, 2008
ClinicalTrials.gov Identifier:	NCT00678353
Health Authority:	United States: Food and Drug Administration

Keywords provided by Stryker Biotech:

Degenerative disc disease

Study placed in the following topic categories:

Spinal Diseases
Musculoskeletal Diseases
Spondylolisthesis
Bone Diseases

ClinicalTrials.gov processed this record on January 15, 2009