Clinical trial NCT00677950: OP-1 Putty for Posterolateral Fusions
Official title: OP-1 Putty for Posterolateral Fusions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Degenerative Lumbar Spondylolisthesis
Keywords: Degenerative Disc Disease
Lead sponsor: Olympus Biotech Corporation
Sponsor class: INDUSTRY
First posted: 2008-05-15
Enrollment: 336
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The trial was designed to demonstrate the comparability of the overall success rate in the OP-1 Putty treatment group to the autograft treatment group.

Detailed description: A controlled, open- label, blinded radiographic assessment, randomized, prospective, multicenter, multinational pivotal study in which patients with single level (L3-S1) degenerative lumbar spondylolisthesis (Grade 1 or 2) with spinal stenosis underwent decompression and spinal fusion and received OP-1 Putty or autograft. This study was a one-sided, non- inferiority trial comparing the overall success between the OP-1 Putty group and the control autograft group.

Eligibility criteria: Inclusion Criteria:

1. The subject has a diagnosis of Degenerative Lumbar Spondylolisthesis of Grade I or II with Spinal Stenosis demonstrated by medical history, physical examination a n d radiographic imaging.
2. The subject is a candidate for decompression and spinal fusion with the use of autograft from the iliac crest.
3. The subject requires one level lumbar fusion (L-3 to S-1).
4. The subject has a preoperative Oswestry Disability Index of 30-100.

Exclusion Criteria:

1. The subject has active spinal and/or systemic infection.
2. The subject is morbidly obese.
3. The subject has a known sensitivity to any component of the OP-1 Putty.
4. The subject has spinal instability measured on flexion / extension radiographs of greater than 50% translation of the vertebrae and greater than or equal to 20 degrees of angular motion.
5. The subject uses tobacco or nicotine or is prescribed steroids such as cortisone.

Primary outcomes:
measure: Overall success rate at 24 months in the OP-1 Putty and the autograft groups, radiographic demonstration of spinal fusion, ODI improvement of at least 20%, no revisions, removals or supplemental fixations
timeFrame: 3, 6, 12, 24 months
Secondary outcomes:
measure: The number of anticipated and unanticipated complications/AEs that occurred within the study population, Visual Analog Scale Results for Pain Assessment, Donor Site Pain, Medication Use
timeFrame: 3, 6, 12, 24 months
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: Newark
country: United States
state: Delaware
city: Clearwater
country: United States
state: Florida
city: Ft. Lauderdale
country: United States
state: Florida
city: Miami
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: