NCT01494441

Pilot Study of rhBMP/BCP With or Without the TSRH® Spinal System for Posterolateral Lumbar Fusion in Patients With Degenerative Disc Disease

A Pilot Study of Recombinant Human Bone Morphogenetic Protein-2 and Biphasic Calcium Phosphate With or Without the TSRH® Spinal System for Posterolateral Lumbar Fusion in Patients With Symptomatic Degenerative Disc Disease

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 27 (actual)
• Sponsor: Medtronic Spinal and Biologics · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this pilot clinical trial is to evaluate both device designs (rhBMP-2/BCP and rhBMP-2/BCP/TSRH® spinal System) as methods of facilitating spinal fusion as compared to instrumented fusion with autograft in patients with symptomatic degenerative disc disease.

Conditions

• Degenerative Disc Disease

Interventions

Type	Name	Description
PROCEDURE	rhBMP-2/BCP	The rhBMP-2/BCP device component consists of recombinant human Bone Morphogenetic Protein-2 ( rhBMP-2) and the biphasic calcium phosphate (BCP) carrier.
DEVICE	rhBMP-2/BCP/TSRH® Spinal System	rhBMP-2/BCP device will be used in conjunction with the posterior spinal fixation system, the TSRH® Spinal System.
DEVICE	Autograft/TSRH® Spinal System	The control device will be autogenous bone from the iliac crest of the patient used in conjunction with the TSRH® spinal System.

Timeline

• Start date: 1999-05-01
• Primary completion: 2003-03-01
• Completion: 2003-03-01
• First posted: 2011-12-19
• Last updated: 2023-05-17