Status:
COMPLETED
Pilot Study of rhBMP-2/BCP in Patients With Spinal Degeneration With Instability Requiring Surgical Fusion
Lead Sponsor:
Medtronic Spinal and Biologics
Conditions:
Degenerative Disc Disease
Eligibility:
All Genders
18+ years
Phase:
NA
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 ...
Eligibility Criteria
Inclusion
- 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-S1.
- 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
- 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-S1.
- 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.
- Subject has history of endocrine or metabolic disorder known to affect osteogenesis (e.g. Paget's disease, renal osteodystrophy, Ehlers Danlos syndrome, or osteogenesis imperfecta).
- Subject has a known diagnosis of diabetes which requires treatment with medication.
- Subject has received previous radiation therapy at the site to be fused.
- Subject is unwilling to return for required follow-up visits.
- Subject is a prisoner.
- Subject has insufficient bone mass which precludes surgery (e.g., severe osteopenia or osteoporosis).
Key Trial Info
Start Date :
October 1 1996
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2001
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT01495234
Start Date
October 1 1996
End Date
June 1 2001
Last Update
May 17 2023
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