A Clinical Study of Recombinant Human Bone Morphogenetic Protein-2 and Biphasic Calcium Phosphate With Either the TSRH® Spinal System or the CD Horizon® Spinal System for Posterolateral Lumbar Fusion in Patients With DDD
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Degenerative Disc Disease
- Sponsor
- Medtronic Spinal and Biologics
- Enrollment
- 197
- Primary Endpoint
- Pain/Disability Status
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
This study is designed to assess the safety and effectiveness of the rhBMP/BCP/TRSH Spinal System in treatment of the patients with degenerative disc disease.
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° translation \>= 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 one or two adjacent levels from L1 to S1 requiring fusion.
Exclusion Criteria
- •Has primary diagnosis of a spinal disorder other than degenerative disc disease with Grade 1 spondylolisthesis at the involved levels.
- •Had previous spinal fusion surgical procedure at the involved levels.
- •Has a condition that 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 or prior history of malignancy (except for basal cell carcinoma of the skin).
- •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.
Outcomes
Primary Outcomes
Pain/Disability Status
Time Frame: 24 month
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
Fusion
Time Frame: 24 month
Fusion is defined as: 1. Evidence of bridging trabecular bone. 2. No evidence of motion as defined by: a. No more than 3mm difference in translation on the lateral flexion/extension radiographs as 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; 3. Absence of radiolucent lines completely through the fusion mass.
Secondary Outcomes
- Patient global perceived effect(24 month)
- Neurological status(24 month)
- General health status (SF-36)(24 month)
- Patient satisfaction(24 month)
- Hip (Donor Site) pain(24 month)
- Pain status (back pain, leg pain)(24 month)