Clinical trial NCT00678353: Study of OP-1 Putty in Uninstrumented Posterolateral Fusions
Official title: Prospective Data Collection From the Stryker Biotech Pivotal IDE Study of OP-1 Putty in Uninstrumented Posterolateral Fusions
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Degenerative Lumbar Spondylolisthesis
Keywords: Degenerative disc disease
Lead sponsor: Olympus Biotech Corporation
Sponsor class: INDUSTRY
First posted: 2008-05-15
Enrollment: 202
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients treated in clinical protocol S01-01US

Brief 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.

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 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.

Primary outcomes:
measure: Evidence of bone by CT scan
timeFrame: 3+ years post-treatment from the Pivotal study S01-01US
Secondary outcomes:
measure: Re-assessments of all clinical parameters from S01-01US
timeFrame: 3+ years post-treatment from the Pivotal study S01-01US
Other outcomes:
Locations:
city: Santa Monica
country: United States
state: California
city: Stanford
country: United States
state: California
city: Denver
country: United States
state: Colorado
city: Clearwater
country: United States
state: Florida
city: Ft. Lauderdale
country: United States
state: Florida
city: Chicago
country: United States
state: Illinois
city: Kalamazoo
country: United States
state: Michigan
city: Southfield
country: United States
state: Michigan
city: St. Louis
country: United States
state: Missouri
city: New York
country: United States
state: New York
city: Rochester
country: United States
state: New York
city: Charlotte
country: United States
state: North Carolina
city: Akron
country: United States
state: Ohio
city: Philadelphia
country: United States
state: Pennsylvania
city: Pittsburgh
country: United States
state: Pennsylvania
city: Germantown
country: United States
state: Tennessee
city: San Antonio
country: United States
state: Texas
city: Charlottesville
country: United States
state: Virginia
city: Fairfax
country: United States
state: Virginia
city: Halifax
country: Canada
state: Nova Scotia
city: London
country: Canada
state: Ontario
city: Toronto
country: Canada
state: Ontario
Study officials:
References: