Study of OP-1 Putty in Uninstrumented Posterolateral Fusions

Degenerative Lumbar Spondylolisthesis Clinical Trial

Official title:

Prospective Data Collection From the Stryker Biotech Pivotal IDE Study of OP-1 Putty in Uninstrumented Posterolateral Fusions

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00678353
• Other study ID #: 06-UPLF-01
• Status: Completed
• Phase: N/A
• First received: May 13, 2008
• Last updated: June 9, 2011
• Start date: May 2007
• Est. completion date: August 2007

Study information

• Verified date: June 2011
• Source: Olympus Biotech Corporation
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Observational

Clinical Trial Summary

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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 202
• Est. completion date: August 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

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.

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Degenerative Lumbar Spondylolisthesis
• Spondylolisthesis

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Olympus Biotech Corporation

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evidence of bone by CT scan		3+ years post-treatment from the Pivotal study S01-01US	No
Secondary	Re-assessments of all clinical parameters from S01-01US		3+ years post-treatment from the Pivotal study S01-01US	No