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
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Degenerative Disc Disease
- Sponsor
- Medtronic Spinal and Biologics
- Enrollment
- 46
- Primary Endpoint
- Severity and Rate of Implant-Associated Adverse Events
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
The purpose of this pilot clinical trial is to evaluate the device design as a method of facilitating spinal fusion.
Investigators
Eligibility Criteria
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 \>
- •Has no greater than Grade 1 spondylolisthesis utilizing Meyerding's Classification (Meyerding HW, 1932.).
- •Has single-level symptomatic degenerative involvement from L4 to S
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.
Outcomes
Primary Outcomes
Severity and Rate of Implant-Associated Adverse Events
Time Frame: 24 month
Rate of Implant Revision, Removal and Supplemental Fixation Procedures
Time Frame: 24 month
Incidence of Permanent Adverse Events
Time Frame: 24 month
Fusion
Time Frame: 24 month
Fusion is defined as: 1. 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. 2. Angulation \< 5°. 3. Translation \< 3mm. 4. Absence of radiolucent lines around more than 50% of either implant.
Disc Height Measurement
Time Frame: 24 month
Disc height will be measured postoperative and compared to the preoperative measurement. Maintenance or improvement in disc height will be determined a success.
Pain/Disability Status
Time Frame: 24 month
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
Neurological Status
Time Frame: 24 month
Neurological status will be assessed preoperatively and postoperatively using a comprehensive neurological status scale.
Secondary Outcomes
- Patient Satisfaction/Quality of Life Status (SF-36)(24 month)
- 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)
- Pain Status (Numerical Rating Scale)(24 month)
- Overall Success(24 months)