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

NCT01495234 | Completed

• 1 other identifier: DOC#1187b BCP -Mexico
• Study Type: interventional
• Target: 15
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Degenerative Disc Disease

Keywords

Spinal degeneration

Outcome Measures

Primary Outcomes (1)

• Fusion Status

  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.

  12 month

Secondary Outcomes (4)

• Oswestry Low Back Pain Disability Questionnaire Status

  12 month

• Neuro/Functional Status

  12 month

• Neurological Status

  12 month

• General Health Status (SF-36)

  12 month

Study Arms (2)

Cohort 1

EXPERIMENTAL

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.

Device: rhBMP-2/BCP device

Cohort 2

EXPERIMENTAL

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

Device: rhBMP-2/BCP device

Interventions

rhBMP-2/BCP device DEVICE

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

Also known as: Recombinant human bone morphogenetic protein-2

Cohort 1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Medtronic Spinal and Biologics: lead

MeSH Terms

Conditions

Intervertebral Disc Degeneration

Condition Hierarchy (Ancestors)

Spinal Diseases; Bone Diseases; Musculoskeletal Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 12, 2011
• First Posted: December 19, 2011
• Study Start: October 1, 1996
• Primary Completion: June 1, 2001
• Study Completion: June 1, 2001
• Last Updated: May 17, 2023

Record last verified: 2023-05