OP-1 Putty for Posterolateral Fusions

Degenerative Lumbar Spondylolisthesis Clinical Trial

Official title:

OP-1 Putty for Posterolateral Fusions

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00677950
• Other study ID #: S01-01US
• Status: Completed
• Phase: N/A
• First received: May 13, 2008
• Last updated: June 9, 2011
• Start date: October 2001
• Est. completion date: November 2005

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: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 336
• Est. completion date: November 2005
• Est. primary completion date: November 2003
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Degenerative Lumbar Spondylolisthesis
• Spondylolisthesis

Intervention

Procedure:
• Spinal fusion
Surgical procedure for lumbar spinal posterior decompression with concomitant posterolateral intertransverse process arthrodesis

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	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		3, 6, 12, 24 months	No
Secondary	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		3, 6, 12, 24 months	No