A Phase 4 interventional study of Z-Brace interbody fusion device and PEEK interbody fusion device in Cervical Disc Degeneration, sponsored by National Taiwan University Hospital. Recruiting at 13 sites in Taiwan. Open to participants aged 20 Years to 69 Years. Per ClinicalTrials.gov, last updated 2024-05-24.
Sponsored by National Taiwan University Hospital · Phase 4, Interventional, and Treatment
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.
This study is a randomized, prospective, multicenter clinical trial comparing rigid (PEEK) interbody fusion device with non-rigid (Titanium Alloy, Z-Brace, Baui Biotech) interbody fusion device in ACDF surgery at 11 clinical sites. ACDF was performed with stand-alone interbody fusion device and artificial bone graft (hydroxyapatite/tricalcium phosphate). Patients have 1-level or 2-level cervical degenerative disc disease approved for ACDF surgery by National Health Insurance, which is the blind, third-party, administrative approved and insurance reimbursement for surgical indication. Total 180 patients were enrolled, and 180 patients were randomized into either investigational device (non-rigid) group or the control (rigid) group in a 2:1 ratio. After confirming a patient's eligibility and having the patient sign an informed consent form, the site investigator or study coordinator call the coordinator at National Taiwan University Hospital for the randomization. Each patient will be then assigned to 1 of the treatment group according to a randomized schedule. Patient were evaluated preoperatively, one month postoperatively, and 3, 6, 12, 18, and 24 months postoperatively. Measured outcomes included overall success, Neck Disability Index (NDI), VAS neck and arm pain, adjacent range of motion, patient satisfaction, anxiety score, SF-12 MCS/PCS, major complications, subsequent surgery rate, and subsidence and fusion rate on radiological examinations. The primary endpoint was a FDA composite definition of success comprising clinical improvement and absence of major complications and secondary surgery events.
464 studies on the registry are indexed under Intervertebral Disc Degeneration; 98 are open to participants now.
This study's planned enrollment of 180 is above the median of 60 across 261 interventional studies indexed under Intervertebral Disc Degeneration.
Browse Intervertebral Disc Degeneration studies →National Taiwan University Hospital is the lead sponsor of 2,563 studies on the registry; 569 are open to participants now.
Of its 11 completed or terminated interventional studies of FDA-regulated products, 2 (18%) have results posted.
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Exclusion Criteria:
Use non-rigid (Titanium Alloy, Z-Brace, Baui Biotech) interbody fusion device.
Combination Product: Z-Brace interbody fusion device
Use rigid (PEEK) interbody fusion device .
Combination Product: PEEK interbody fusion device
Use non-rigid (Titanium Alloy, Z-Brace, Baui Biotech) interbody fusion device in Anterior Cervical Discectomy and Fusion (ACDF) surgery
Use rigid (PEEK) interbody fusion device in Anterior Cervical Discectomy and Fusion (ACDF) surgery
Change from baseline postoperative condition (if patients have major complications)
No adverse events (AEs) classified as major complications by Research Ethics Committee.
Time frame: Patient were evaluated one month postoperatively, and 3, 6, 12, 18, and 24 months postoperatively.
Change from baseline postoperative condition (if patients have subsequent surgeries)
No subsequent surgical intervention.
Time frame: Patient were evaluated one month postoperatively, and 3, 6, 12, 18, and 24 months postoperatively.
Change from baseline Subsidence and Fusion rate
Subsidence and fusion rate on radiological.
Time frame: Patient were evaluated one month postoperatively, and 3, 6, 12, 18, and 24 months postoperatively.
Change from baseline Adjacent range of motion
Adjacent range of motion on radiological.
Time frame: Patient were evaluated preoperatively, one month postoperatively, and 3, 6, 12, 18, and 24 months postoperatively.
Change from baseline Neck Disability Index (NDI)
An improvement in Neck Disability Index (NDI) score of at least 30 points for a patient with a preoperative NDI score of 60 or greater; or an improvement of at least 50% of preoperative NDI score for patients with a preoperative score of less than 60.
Time frame: Patient were evaluated preoperatively, one month postoperatively, and 3, 6, 12, 18, and 24 months postoperatively.
Visual analogue scale (neck and arm and chest pain)
Patient will be evaluated by Visual analogue scale(VAS) for their neck, arm and chest pain. The minimum value is 0 and the maximum value is 10. Higher score means a worse outcome.
Time frame: Patient were evaluated preoperatively, one month postoperatively, and 3, 6, 12, 18, and 24 months postoperatively.
Patient Satisfaction Questionnaire
Patients will be surveyed by Patient Satisfaction Questionnaire. There are two questions on the questionnaire to evaluate if they are satisfied with their treatment and if they will recommend their respective surgery to a friend.
Time frame: Patient were evaluated one month postoperatively, and 3, 6, 12, 18, and 24 months postoperatively.
Anxiety score
The Beck Anxiety Inventory (BAI). The minimum value is 0 and the maximum value is 63. Higher scores mean a worse outcome.
Time frame: Patient were evaluated preoperatively, one month postoperatively, and 3, 6, 12, 18, and 24 months postoperatively.
Short form-12 mental component scale and physical component scale (SF-12 MCS/PCS) score
Short form-12 mental component scale and physical component scale. The minimum value of physical component scale (PCS-12) is 18.4 and the maximum value of PCS-12 is 57.8. The minimum value of mental component scale (MCS-12) is 18.7 and the maximum value of MCS-12 is 65.2. Higher scores mean a better outcome.
Time frame: Patient were evaluated preoperatively, one month postoperatively, and 3, 6, 12, 18, and 24 months postoperatively.
Number of days using Non-steroidal anti-inflammatory analgesics(NSAIDs)
Number of days using Non-steroidal anti-inflammatory analgesics(NSAIDs)
Time frame: Patient were evaluated preoperatively, one month postoperatively, and 3, 6, 12, 18, and 24 months postoperatively.
Depression Score
Beck Depression Inventory(BDI). The minimum value is 0 and the maximum value is 63. Higher scores mean a worse outcome.
Time frame: Patient were evaluated preoperatively, one month postoperatively, and 3, 6, 12, 18, and 24 months postoperatively.
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National Taiwan University Hospital