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

Study Overview
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Brief Summary
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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.

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

Conditions
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Degenerative Disc Disease

Intervention / Treatment
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* Device: rhBMP-2/BCP device
* Device: rhBMP-2/BCP device


Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cohort 1<br>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<br>* The rhBMP-2/BCP device consists of recombinant human Bone Morphogenetic Protein-2 (rhBMP-2) and the biphasic calcium phosphate (BCP) carrier.<br>* Other names: Recombinant human bone morphogenetic protein-2;|
| Experimental: Cohort 2<br>Each patient will receive 20mg of rhBMP-2 in rhBMP-2/BCP device and implant bilaterally. | Device: rhBMP-2/BCP device<br>* The rhBMP-2/BCP device consists of recombinant human Bone Morphogenetic Protein-2 (rhBMP-2) and the biphasic calcium phosphate (BCP) carrier.<br>* Other names: recombinant human Bone Morphogenetic Protein-2;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fusion Status | Fusion will be met all of the following criteria: Evidence of bridging trabecular bone; Angular motion < 5°; Translational motion <= 3mm; No radiolucent lines spanning the entire fusion mass. | 12 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Oswestry Low Back Pain Disability Questionnaire Status |  | 12 month | 
| Neuro/Functional Status | A neurological functional questionnaire will be completed by patients prior to surgery and postoperative, including three questions pertaining to pain (severity of pain, location of pain, and leg pain side), and four questions associated with functional activities (recreational activity level, putting on shoes and socks, squatting, occupation activity level). Success will be based on a maintenance or improvement from the preoperative condition for the functional components, except that severity of pain success will be based on an improvement of at least one point on the five point scale. | 12 month | 
| Neurological Status | A scale will be used to measure neurological status. This scale focuses on reflexes, sensory, motor function, and the degree of straight leg raise reproducing pain. All of these elements are combined to give an overall score. Success will be based on a maintenance or improvement in all categories from the preoperative condition. | 12 month | 
| General Health Status (SF-36) |  | 12 month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Spinal degeneration