A Pilot Study of rhBMP-2/ACS/Allograft Bone Dowel for Anterior Lumbar Interbody Fusion in Patients With Symptomatic 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 the device design as a method of facilitating spinal fusion.

Official Title
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A Clinical Investigation of Recombinant Human Bone Morphogenetic Protein-2 and Absorbable Collagen Sponge With Allograft Bone Dowel for Anterior Lumbar Interbody Fusion in Patients With Symptomatic Degenerative Disc Disease

Conditions
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Degenerative Disc Disease

Intervention / Treatment
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* Device: rhBMP-2/ACS/allograft bone dowel
* Device: Autogenous bone/allograft bone dowel


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Has degenerative disc disease as 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 >= 2-4mm, 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 > 35. Has no greater than Grade 1 spondylolisthesis utilizing Meyerding's Classification (Meyerding HW, 1932.). Has single-level symptomatic degenerative involvement from L4 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: Had previous anterior spinal fusion surgical procedure at the involved level. Has a condition which requires postoperative medications that interfere with fusion, such as steroids or nonsteroidal antiinflammatory drugs (this does not include low dose aspirin for prophylactic anticoagulation). Has 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 obese, i.e., weight greater than 40% over ideal for their age and height. Has fever (temperature> 101° F oral) at the time of surgery. 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. Is a tobacco user at the time of surgery. Patient has received drugs which may interfere with bone metabolism within two weeks prior to the planned date of spinal fusion surgery (e.g., steroids or methotrexate). Patient has a history of autoimmune disease (Systemic Lupus Erythematosus or Dermatomyositis). Patient has a history of exposure to injectable collagen implants. Patient's history includes hypersensitivity to protein pharmaceuticals (monoclonal antibodies or gamma globulins) or collagen. Patient 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/ACS implantation. Patient has received any previous exposure to BMP. Patient has a history of severe allergy, an allergy to bovine products, or a history of anaphylaxis. Patient 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/ACS<br> | Device: rhBMP-2/ACS/allograft bone dowel<br>* The rhBMP-2/ACS will be used in conjunction with an allograft bone dowel.<br>* Other names: Recombinant human bone morphogenetic protein-2;|
| Active Comparator: Autogenous Bone<br> | Device: Autogenous bone/allograft bone dowel<br>* An allograft bone dowel contains autogenous bone taken from the patient's iliac crest.<br>* Other names: Autograft;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Severity and Rate of Implant-Associated Adverse Events |  | 24 month | 
| Rate of Implant Revision, Removal and Supplemental Fixation Procedures |  | 24 month | 
| Incidence of Permanent Adverse Events |  | 24 month | 
| Fusion | Fusion is defined as: Bone observed connecting with the vertebral bodies above and below either through the implants; lateral to or between the implants; or anterior/posterior to the implants. Angulation < 5°. Translation < 3mm. Absence of radiolucent lines around more than 50% of either implant. | 24 month | 
| Disc Height Measurement | Disc height will be measured postoperative and compared to the preoperative measurement. Maintenance or improvement in disc height will be determined a success. | 24 month | 
| Pain/Disability Status | The self-administered Oswestry Low Back Pain Disability Questionnaire will be used. Success will be defined as pain/disability improvement postoperatively according to the following definition: Preoperative Score - Postoperative Score >= 15 | 24 month | 
| Neurological Status | Neurological status will be assessed preoperatively and postoperatively using a comprehensive neurological status scale. | 24 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Nature and Frequency of Adverse Events Not Associated with the Implants |  | 24 month | 
| Rate of Reoperation Procedures |  | 24 month | 
| Hip (Donor Site) Pain Status |  | 24 month | 
| Patient Satisfaction/Quality of Life Status (SF-36) |  | 24 month | 
| Pain Status (Numerical Rating Scale) |  | 24 month | 
| Overall Success | A patient will be considered an overall success if all of the following conditions are met: fusion disc height maintenance or improvement pain/disability (Oswestry) improvement maintenance or improvement in neurological status no permanent adverse event no additional surgical procedure classified as a failure. | 24 months | 

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