Evaluation of Cervical Fusion With DTRAX® Cervical Cage With DTRAX Bone Screw (NCT02694250) | Clinical Trial Compass
WithdrawnNot Applicable
Evaluation of Cervical Fusion With DTRAX® Cervical Cage With DTRAX Bone Screw
Stopped: study not started due to lack of resources
United States0Started 2015-11
Plain-language summary
This study is being conducted to assess the radiographic (x-rays and CT scans) and clinical outcomes for the use of DTRAX Cervical Cage with DTRAX Bone Screw for the treatment of degenerative disc disease at one disc level with accompanying radicular symptoms in the cervical (neck) spine.
Who can participate
Age range35 Years – 80 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Subject diagnosed with one level cervical spondylosis with radiculopathy in C3-C7, defined as follows:
✓. 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 clinically indicated sooner due to the presence of progressive symptoms or signs of nerve root in spite of combined nonoperative management.
✓. Preoperative Neck Disability Index (NDI) score of \> 30.
✓. Preoperative Neck pain or Arm pain score of \> 6 on Neck and Arm VAS Pain Scales.
✓. Subject is a male or non-pregnant, non-lactating female.
✓. Subject must have the ability to understand and voluntarily provide written, informed consent.
Exclusion criteria
✕. Any previous cervical spinal surgery.
✕. Subject has known osteoporosis, osteomalacia, spinal metastases, or metabolic bone disease OR subject has sustained a vertebral compression or nontraumatic hip or wrist fracture.
✕. Subject has overt or active spinal and/or systemic infection.
✕. Subject has cervical spondylolisthesis \> 3.5mm or rotator subluxation.
What they're measuring
1
Assess the radiographic outcome data on fusion status, device retention, and maintenance of segmental lordosis at the index level utilizing DTRAX Cervical Cage with DTRAX Bone Screw used in the treatment of cervical radiculopathy
Timeframe: Baseline throughout 24 months post-operatively
✕. Subject has radicular findings with major motor impairment.
✕. Subject has a condition that requires postoperative medications that interfere with fusion or the stability of the implant, such as steroids (ie. corticosteroids, methotrexate, immunosuppressives).