A Pilot Investigation of Recombinant Human Bone Morphogenetic Protein- 2/Biphasic Calcium Phosphate in Patients With Spinal Degeneration With Instability Requiring Surgical Fusion

Medtronic Spinal and Biologics0 sites15 target enrollmentOctober 1996

ConditionsDegenerative Disc Disease

Overview

Phase: N/A
Intervention: Not specified
Conditions: Degenerative Disc Disease
Sponsor: Medtronic Spinal and Biologics
Enrollment: 15
Primary Endpoint: Fusion Status
Status: Completed
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief 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.

Registry

clinicaltrials.gov

Start Date

October 1996

End Date

June 2001

Last Updated

2 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Medtronic Spinal and Biologics

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Subject has radiographically documented spinal degeneration with instability as documented by the presence of translation \>= 4mm or angulation \>= 5°.
•Subject has intractable back pain which does not respond to conservative treatment and in the investigator's opinion, requires surgical spinal fusion.
•Subject's pain is predominantly associated with the back.
•Subject has only one level involvement at L3-L4, L4-L5, or L5-S
•Subject is 18 years of age or greater at the time consent is given to participate in the study.
•Subject is willing to comply with the study plan and sign the informed consent.
•Subject is male or a non-pregnant, non-nursing female. All females of child-bearing age must agree to use adequate contraception for a period of no less than 16 weeks following surgery.

Exclusion Criteria

•Subject has primary spinal diagnosis of a disorder other than spinal degeneration with instability at the involved surgical level.
•Subject has spinal stenosis or condition which requires a full laminectomy procedure.
•Subject has had a previous fusion, discectomy or laminectomy procedure at L3-L4, L4-L5 or L5-S
•Subject has received drugs which may interfere with bone metabolism within two weeks prior to the planned date of spinal fusion surgery (e.g., steroids, methotrexate) or has a condition which requires postoperative medications that interfere with fusion (e.g., steroids, nonsteroidal antiinflammatory drugs, or methotrexate).
•Subject has overt or active infection near the operative spinal region.
•Subject has active systemic infection.
•Subject has history of autoimmune disease (Systemic Lupus Erythematosus or Dermatomyositis).
•Subject's history includes hypersensitivity to protein pharmaceuticals (monoclonal antibodies or gamma globulins).
•Subject has received treatment with an investigational therapy within 28 days prior to implantation surgery or such treatment is planned during the 16 weeks following rhBMP-2/BCP implantation.
•The subject requires electrical bone growth stimulation, allograft, or bone substitute as part of treatment.

Outcomes

Primary Outcomes

Fusion Status

Time Frame: 12 month

Fusion will be met all of the following criteria: 1. Evidence of bridging trabecular bone; 2. Angular motion \< 5°; 3. Translational motion \<= 3mm; 4. No radiolucent lines spanning the entire fusion mass.