Comparison of Rigid and Non-Rigid Interbody Fusion Device for Cervical Degenerative Disc Disease … (NCT04550923) | Clinical Trial Compass
RecruitingPhase 4
Comparison of Rigid and Non-Rigid Interbody Fusion Device for Cervical Degenerative Disc Disease in Adults
Taiwan180 participantsStarted 2020-12-03
Plain-language summary
Rigid interbody fusion device in bulk configuration has been widely used in anterior cervical discectomy and fusion (ACDF) surgery. It is a randomized, prospective, multicenter clinical study to compare rigid and non-rigid fusion device in ACDF for cervical degenerative disc disease.
Who can participate
Age range20 Years – 69 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
✓. Age 20 - 69 years;
✓. Symptomatic cervical degenerative disc disease in one or two levels between C3-7 with radiculopathy or myeloradiculopathy and/or decrease muscle strength and/or abnormal sensation and/or abnormal reflexes;
✓. Deficit confirmed by CT, MRI, or X-ray;
✓. NDI Score of ≥ 30/100;
✓. Unresponsive to non-operative treatment of at least 6 weeks or presence of progressive symptoms or signs of nerve root/spinal cord compression despite continued non-operative treatment;
✓. No prior surgical procedures at the operative level and non-prior fusions at any cervical level;
✓. Physically and mentally able and willing to comply with the protocol;
✓. Signed informed consent;
Exclusion criteria
✕. Patient does not meet the indication of Anterior Cervical Discectomy and Fusion (ACDF), which is under the surveillance. (Surgical indication of ACDF is approved by National Health Insurance Administration Ministry of Health and Welfare, a blinded third-party authority).
✕. More than two vertebral levels required surgery;
✕. Immobile levels between C1 and C7 from any cause;
✕. Any prior surgery at the operative level or any prior fusion at any cervical level;
What they're measuring
1
Change from baseline postoperative condition (if patients have major complications)
Timeframe: Patient were evaluated one month postoperatively, and 3, 6, 12, 18, and 24 months postoperatively.
2
Change from baseline postoperative condition (if patients have subsequent surgeries)
Timeframe: Patient were evaluated one month postoperatively, and 3, 6, 12, 18, and 24 months postoperatively.
3
Change from baseline Subsidence and Fusion rate
Timeframe: Patient were evaluated one month postoperatively, and 3, 6, 12, 18, and 24 months postoperatively.
4
Change from baseline Adjacent range of motion
Timeframe: Patient were evaluated preoperatively, one month postoperatively, and 3, 6, 12, 18, and 24 months postoperatively.
5
Change from baseline Neck Disability Index (NDI)
Timeframe: Patient were evaluated preoperatively, one month postoperatively, and 3, 6, 12, 18, and 24 months postoperatively.
✕. T-score less than -1.5 (osteoporosis evaluation)
✕. Paget's disease, osteomalacia, or any other metabolic bone disease other than osteoporosis;
✕. Active infection of surgical site or history of anticipated treatment for systemic infection including HIV
✕. Active malignancy: a history of any invasive malignancy (except carcinoma in situ and non-melanoma skin cancer), unless treated with curative intent with no clinical signs or symptoms of malignancy in the past 5 years;