A Prospective Pilot Study of the OP-1 Putty in Uninstrumented Posterolateral Fusions - Full Text View

Sponsored by:	Stryker Biotech
Information provided by:	Stryker Biotech
ClinicalTrials.gov Identifier:	NCT00679107

Purpose

This study will explore the use of OP-1 Putty in conjunction with surgical treatment for the treatment of spinal decompression and lumbar spinal fusion.

Condition	Intervention
Degenerative Lumbar Spondylolisthesis	Device: Use of OP-1 Putty in Uninstrumented posterolateral fusion

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Prospective, Randomized, Controlled, Multicenter, Pilot Study of the OP-1 Putty in Uninstrumented Posterolateral Fusions

Further study details as provided by Stryker Biotech:

Primary Outcome Measures:

Safety, by comparison of the complications and neurological status within the OP-1treatment groups and the control group (autograft alone). [ Time Frame: 6 weeks; 3, 6, 9, 12, and 24 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Efficacy, by comparison of overall fusion success and time to fusion along with pain / function outcome within the OP-1 treatment groups and the control group (autograft alone). [ Time Frame: 6 weeks; 3, 6, 9, 12, and 24 months ] [ Designated as safety issue: No ]

Enrollment:	48
Study Start Date:	June 1999
Study Completion Date:	July 2005
Primary Completion Date:	December 2000 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental autogenous bone graft with the addition of OP-1 Putty	Device: Use of OP-1 Putty in Uninstrumented posterolateral fusion Use of OP-1 Putty in Uninstrumented posterolateral fusion
2: Active Comparator autogenous bone graft alone	Device: Use of OP-1 Putty in Uninstrumented posterolateral fusion Use of OP-1 Putty in Uninstrumented posterolateral fusion

Detailed Description:

It is postulated that the addition of OP-1 Putty to autogenous bone will prove beneficial in the treatment of patients requiring decompression and lumbar spinal fusion. The Investigational system is intended to stimulate bone growth. It is indicated as an adjunct or a replacement for autograft in spinal fusion.

Eligibility

Ages Eligible for Study:	18 Years to 81 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

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.
The subject is a candidate for decompression and spinal fusion with the use of autograft from the iliac crest.
The subject requires one level lumbar fusion (L-3 to S-1).
The subject has a preoperative Oswestry Disability Index of 30-100.

Exclusion Criteria:

The subject has active spinal and/or systemic infection.
The subject is morbidly obese.
The subject has a known sensitivity to any component of the OP-1 Putty.
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.
The subject uses tobacco or nicotine or is prescribed steroids such as cortisone.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00679107

Locations

United States, Connecticut

New Haven, Connecticut, United States
United States, Illinois

Chicago, Illinois, United States
United States, Michigan

Royal Oak, Michigan, United States
United States, Ohio

Akron, Ohio, United States
United States, Pennsylvania

Philadelphia, Pennsylvania, United States

Sponsors and Collaborators

Stryker Biotech

Investigators

Study Director:

Frances Newton

Stryker Biotech

More Information

Responsible Party:	Stryker Biotech ( Frances Newton )
Study ID Numbers:	S99-01US
Study First Received:	May 13, 2008
Last Updated:	November 7, 2008
ClinicalTrials.gov Identifier:	NCT00679107
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