Pilot Study of rhBMP/BCP With or Without the TSRH® Spinal System for Posterolateral Lumbar Fusion in Patients With Degenerative Disc Disease

Study Overview
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Brief Summary
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The purpose of this pilot clinical trial is to evaluate both device designs (rhBMP-2/BCP and rhBMP-2/BCP/TSRH® spinal System) as methods of facilitating spinal fusion as compared to instrumented fusion with autograft in patients with symptomatic degenerative disc disease.

Official Title
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A Pilot Study of Recombinant Human Bone Morphogenetic Protein-2 and Biphasic Calcium Phosphate With or Without the TSRH® Spinal System for Posterolateral Lumbar Fusion in Patients With Symptomatic Degenerative Disc Disease

Conditions
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Degenerative Disc Disease

Intervention / Treatment
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* Procedure: rhBMP-2/BCP
* Device: rhBMP-2/BCP/TSRH® Spinal System
* Device: Autograft/TSRH® Spinal System


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Has degenerative disc diseases noted by back pain of discogenic origin,with or without leg pain, with degeneration of the disc confirmed by patient history ( e.g., pain [leg, back, or symptoms in the sciatic nerve distribution] function deficit and/or neurological deficit) and radiographic studies ( e.g., CT, MRl, X-Ray,etc.) to include one or more of the following: instability (defined as angular motion > 5° and/or translation > 4 mm, based on Flex/Ext radiographs); osteophyte formation; decreased disc height; thickening of ligamentous tissue; disc degeneration or herniation; and/or facet joint degeneration. Has preoperative Oswestry score > 30. Has no greater than Grade 1 spondylolisthesis utilizing Meyerding's Classification (Meyerding HW,1932.). Requires fusion of a single level disc space from L1 to S1. Is at least 18 years of age, inclusive, at the time of surgery. Has not responded to non-operative treatment ( e.g., bed rest, physical therapy, medications, spinal injections, manipulation, and/or TENS) for a period of at least 6 months. If female of child-bearing potential, who is not pregnant or nursing, and who agrees to use adequate contraception for 16 weeks following surgery. Is willing and able to comply with the study plan and sign the Patient Informed Consent Form. Exclusion Criteria: Has primary diagnosis of a spinal disorder other than degenerative disc disease with Grade1 or less spondylolisthesis at the involved level. Had previous spinal fusion surgical procedure at the involved level. Require spinal fusion at more than one lumbar level. Has a condition which requires postoperative medications that interfere with fusion, such as steroids. Has been previously diagnosed with osteopenia, osteoporosis, or osteomalacia to a degree that spinal instrumentation would be contraindicated. Has presence of active malignancy. Has overt or active bacterial infection, either local or systemic. Is grossly obese, i.e., weight > 40% over ideal for their age and height. Has fever ( temperature >101°F oral) at the time of surgery. Has a documented titanium alloy allergy or intolerance. Is mentally incompetent. If questionable, obtain psychiatric consult. Has a Waddell Signs of Inorganic Behavior score of 3 or greater. Is a prisoner. Is an alcohol and/or drug abuser as defined by currently undergoing treatment for alcohol and/or drug usage. Is a tobacco user at the time of surgery. Has received drugs which may interfere with bone metabolism within two weeks prior to the planned date of spinal fusion surgery (e.g., NSAIDS, steroids or methotrexate). Has a history of autoimmune disease (Systemic Lupus Erythematosus or Dermatomyositis). Has a history of hypersensitivity to protein pharmaceuticals (monoclonal antibodies or gamma globulins). 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. Has received any previous exposure to any/all BMPs of either human or animal extraction. Has a history of severe allergy (anaphylaxis). Has history of endocrine or metabolic disorder known to affect osteogenesis (e.g., Paget's disease, renal osteodystrophy, Ehlers- Danlos syndrome, or osteogenesis imperfecta).

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: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: rhBMP-2/BCP<br> | Procedure: rhBMP-2/BCP<br>* The rhBMP-2/BCP device component consists of recombinant human Bone Morphogenetic Protein-2 ( rhBMP-2) and the biphasic calcium phosphate (BCP) carrier.<br>* Other names: biphasic calcium phosphate;|
| Experimental: rhBMP-2/BCP/TSRH® Spinal System<br> | Device: rhBMP-2/BCP/TSRH® Spinal System<br>* rhBMP-2/BCP device will be used in conjunction with the posterior spinal fixation system, the TSRH® Spinal System.<br>* Other names: biphasic calcium phosphate;|
| Active Comparator: Autograft/TSRH® Spinal System<br> | Device: Autograft/TSRH® Spinal System<br>* The control device will be autogenous bone from the iliac crest of the patient used in conjunction with the TSRH® spinal System.<br>* Other names: Autograft;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fusion | Fusion is defined as: Evidence of bridging trabecular bone. No evidence of motion as defined by: a. No more than 3mm difference in translation on the lateral flexion/extension radiographs determined by superimposing the two views, one upon the other; b. Less than 5° difference in angular motion between flexion and extension as seen on the lateral flexion/extension radiographs; Absence of radiolucent lines completely through the fusion mass. | 24 month | 
| Pain/Disability Status | The self-administered Oswestry Low Back pain Disability Questionnaire will be used. Success for each individual patient will be defined as pain/disability improvement postoperatively according to the following definition: Preoperative Score - Postoperative Score >= 15 | 24 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Neurological Status Success | Neurological status will be assessed preoperatively and postoperatively using a comprehensive neurological status scale. Neurological status is based on four types of measurements (sections): motor, sensory, reflexes and straight leg raise. | 24 month | 
| Hip (Donor Site) Pain |  | 24 month | 
| General Health Status (SF-36) |  | 24 month | 
| Pain Status (back pain, leg pain) |  | 24 month | 
| Patient Satisfaction |  | 24 month | 
| Patient Global Perceived Effect |  | 24 month | 
| Overall Success |  | 24 month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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lumbar degenerative disc disease