Evaluation of DTRAX Graft in Patients With Cervical Degenerative Disc Disease (NCT01616719) | Clinical Trial Compass
WithdrawnNot Applicable
Evaluation of DTRAX Graft in Patients With Cervical Degenerative Disc Disease
Stopped: study was never started due to lack of resources
United States0Started 2012-05
Plain-language summary
DTRAX Graft is used to relieve nerve pressure in the neck in order to provide relief for Cervical Degenerative Disc Disease. This study is being conducted to determine the effectiveness of the graft, and to find out whether or not it provides better results or faster healing than traditional ways of performing surgery for Cervical Degenerative Disc Disease.
Who can participate
Age range35 Years – 80 Years
SexALL
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Inclusion criteria
✓. Subject diagnosed with DDD in C3-C7, defined as follows:
✓. Subject has single-level disease, OR multi-level disease demonstrated radiographically, and confirmed to be symptomatic by one of the following methods:
✓. Subject has dynamic stenosis relieved by traction and made worse by a Spurlings maneuver.
✓. Subject is 35-80 years of age, inclusive.
✓. Subject is unresponsive to 6 weeks conservative, nonoperative treatment, or has the presence of progressive symptoms or signs of nerve root compression in face of combined nonoperative management.
✓. Preoperative NDI score of ≥ 30.
✓. Preoperative neck pain and arm pain score of ≥ 6 on Neck and Arm Pain Scales.
✓. Patient is a male or non-pregnant, non-lactating female.
Exclusion criteria
✕. Subject has severe osteopenia, osteoporosis, osteomalacia, spinal metastases, or metabolic bone disease OR the level of BMD is a T score of -2.5 or below OR patient has sustained a vertebral compression or nontraumatic hip or wrist fracture.
✕. Subject has overt or active spinal and/or systemic infection.
✕. Subject has spondylolisthesis ≥ 3.5mm or rotator subluxation.
✕. Subject has cervical myelopathy.
What they're measuring
1
Gather clinical outcome data on DTRAX Graft.
Timeframe: Baseline throughout 12 months post-operatively