Pilot Study of ZetaFuseâ„¢ Bone Graft for the Treatment of Cervical Degenerative Disc Disease (NCT05971329) | Clinical Trial Compass
RecruitingNot Applicable
Pilot Study of ZetaFuseâ„¢ Bone Graft for the Treatment of Cervical Degenerative Disc Disease
Australia10 participantsStarted 2026-09
Plain-language summary
The goal of this pilot clinical trial is to test the safety and preliminary performance of the ZetaFuse Bone Graft in patient requiring fusion of the C3-C7 vertebral bones due to pain or loss of neurological function.
Participants will be treated with ZetaFuse during surgical intervention to reduce pain and the loss of neurological function.
Who can participate
Age range22 Years – 75 Years
SexALL
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Inclusion criteria
✓. Age 22 to 75 years (inclusive) at the time of enrollment.
✓. Diagnosis of radiculopathy and/or myelopathy of the cervical spine, with pain, paresthesias or paralysis in a specific nerve root distribution C3 through C7, including at least one of the following:
✓. Symptomatic at one or two contiguous levels from C3 to C7.
✓. Radiographically determined pathology at the level to be treated correlating to primary symptoms including at least one of the following:
✓. Neck Disability Index Score ≥ 30/100.
✓. Unresponsive to non-operative treatment (e.g., rest, heat, physical therapy, chiropractor, massage, pain medication) for approximately six weeks from the symptom onset; or has the presence of progressive symptoms or signs of nerve root/spinal cord compression in the face of continued non-operative management.
✓. No previous surgical intervention at the involved levels or any subsequent, planned/staged surgical procedure at the involved or adjacent levels.
✓. Appropriate for treatment using an anterior surgical approach.
Exclusion criteria
✕. A cervical spinal condition other than symptomatic cervical degenerative disc disease requiring surgical treatment at the involved levels.
✕. Documented or diagnosed cervical instability relative to adjacent segments at either level, defined by dynamic (flexion/extension) radiographs showing sagittal plane translation \>3.5 mm or sagittal plane angulation \> 20°.
What they're measuring
1
Subjects with Radiologic Determination of Bone Fusion of the Treated Cervical Vertebral Bones