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

Medtronic

Status: Completed

Conditions: Degenerative Disc Disease

Treatments: Device: rhBMP-2/BCP device

Study type: Interventional

Funder types: Industry

Identifiers

NCT01495234

DOC#1187b BCP -Mexico

Details and patient eligibility

About

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.

Enrollment: 15 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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-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 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-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).

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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15 participants in 2 patient groups

Cohort 1

Experimental group

Description:

Each patient will receive 15mg of rhBMP-2 in rhBMP-2/BCP device and implant unilaterally during a posterolateral spinal fusion procedure. The contralateral side was fused using standard fusion techniques with autograft bone.

Treatment:

Device: rhBMP-2/BCP device

Device: rhBMP-2/BCP device

Cohort 2

Experimental group

Description:

Each patient will receive 20mg of rhBMP-2 in rhBMP-2/BCP device and implant bilaterally.

Treatment:

Device: rhBMP-2/BCP device

Device: rhBMP-2/BCP device