Exploratory Study of 3D Printed Biodegradable Cervical Interbody Fusion Cage (NCT04167878) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Exploratory Study of 3D Printed Biodegradable Cervical Interbody Fusion Cage
China10 participantsStarted 2019-12-01
Plain-language summary
A small sample, single center, non-randomized, noninferiority clinical trial to evaluate the safety and effectiveness of 3D printed biodegradable cervical interbody fusion cage in anterior cervical discectomy and fusion (ACDF) for treating patients with a symptomatic degenerative cervical disc disease at one level from C2/C4 to C7/T1.
Who can participate
Age range25 Years – 85 Years
SexALL
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Inclusion criteria
✓. Skeletally mature patients aged between 25 and 85 years (inclusive);
✓. Symptomatic cervical disc disease (SCDD) in the vertebral level between C2/C3 to C7/T1, correlated with radiculopathy or myelopathy;
✓. Radiographic confirmation (by CT, MRI, x-ray, etc.) of any of the following: herniated nucleus pulposus, spondylosis or loss of disc height;
✓. Requires only one cervical vertebral level to be surgically treated;
✓. Failed at least 12 weeks of conservative treatment;
✓. Patient must understand and sign the Informed Consent document that has been approved by the Ethics committee;
✓. No significant restrictions showed by the pre-surgical routine test and examination.
Exclusion criteria
✕. Skeletally immature patients;
✕. Prior radiation history at anterior cervical area;
✕. Prior surgery at the level to be treated;
✕. More than one vertebral level requiring treatment, confirmed radiologically by X-ray, CT, or MRI
✕. Complication of ossification of the ligamentum flavum, and Ossification of the posterior longitudinal ligament;