MedTrace Logo

Pilot Study of rhBMP-2/BCP in Patients With Spinal Degeneration With Instability Requiring Surgical Fusion

NCT01495234 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2023-05-17

No results posted yet for this study

Summary

This study is designed to generate data relating to patient safety, bone generating activity associated with the use of the rhBMP-2/BCP device as compared to autograft and to evaluate the feasibility of conducting a larger clinical trial in a patient population requiring spinal fusion.

Conditions

  • Degenerative Disc Disease

Interventions

DEVICE

rhBMP-2/BCP device

The rhBMP-2/BCP device consists of recombinant human Bone Morphogenetic Protein-2 (rhBMP-2) and the biphasic calcium phosphate (BCP) carrier.

DEVICE

rhBMP-2/BCP device

The rhBMP-2/BCP device consists of recombinant human Bone Morphogenetic Protein-2 (rhBMP-2) and the biphasic calcium phosphate (BCP) carrier.

Sponsors & Collaborators

  • Medtronic Spinal and Biologics

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
1996-10-31
Primary Completion
2001-06-30
Completion
2001-06-30

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01495234 on ClinicalTrials.gov