NCT01494441View on ClinicalTrials.gov

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

NACompletedINTERVENTIONAL
Enrollment

27

Participants

Timeline

Start Date

May 31, 1999

Primary Completion Date

March 31, 2003

Study Completion Date

March 31, 2003

Conditions
Degenerative Disc Disease
Interventions
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.

All Listed Sponsors
lead

Medtronic Spinal and Biologics

INDUSTRY

NCT01494441 - Pilot Study of rhBMP/BCP With or Without the TSRH® Spinal System for Posterolateral Lumbar Fusion in Patients With Degenerative Disc Disease | Biotech Hunter | Biotech Hunter