Comparing two types of devices for cervical spine surgery

Comparison of Rigid and Non-Rigid Interbody Fusion Device for Cervical Degenerative Disc Disease in Adults - A Randomized, Prospective, Multicenter Clinical Trial

This study is testing whether a rigid or a non-rigid device works better for helping adults with neck problems recover after cervical spine surgery.

Quick facts

• Phase: Phase 4
• Study type: Interventional
• Enrollment: 180 (estimated)
• Ages: 20 Years to 69 Years
• Sex: All
• Sponsor: National Taiwan University Hospital (Academic / other)
• Locations: 13 sites (Taichung, South Dist. and 12 other locations)
• Trial ID: NCT04550923 on ClinicalTrials.gov

What this trial studies

This clinical trial is a randomized, prospective, multicenter study that compares the effectiveness of rigid and non-rigid interbody fusion devices used in anterior cervical discectomy and fusion (ACDF) surgery for adults with cervical degenerative disc disease. A total of 180 patients will be enrolled and randomly assigned to receive either a PEEK rigid device or a Z-Brace non-rigid device. Patients will be evaluated at multiple time points post-surgery to assess outcomes such as pain relief, functional improvement, and overall satisfaction. The study aims to determine which device provides better results in terms of fusion success and patient recovery.

Who should consider this trial

Good fit: Ideal candidates are adults aged 20 to 69 with symptomatic cervical degenerative disc disease affecting one or two levels between C3-7.

Not a fit: Patients who have had prior surgical procedures at the operative level or do not meet the surgical indications for ACDF may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved surgical outcomes and recovery for patients undergoing ACDF for cervical degenerative disc disease.

How similar studies have performed: Other studies have shown success with similar approaches in comparing interbody fusion devices, indicating that this trial builds on existing knowledge in the field.

Eligibility criteria

Inclusion Criteria:

1. Age 20 - 69 years;
2. 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;
3. Deficit confirmed by CT, MRI, or X-ray;
4. NDI Score of ≥ 30/100;
5. 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;
6. No prior surgical procedures at the operative level and non-prior fusions at any cervical level;
7. Physically and mentally able and willing to comply with the protocol;
8. Signed informed consent;

Exclusion Criteria:

1. 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).
2. More than two vertebral levels required surgery;
3. Immobile levels between C1 and C7 from any cause;
4. Any prior surgery at the operative level or any prior fusion at any cervical level;
5. T-score less than -1.5 (osteoporosis evaluation)
6. Paget's disease, osteomalacia, or any other metabolic bone disease other than osteoporosis;
7. Active infection of surgical site or history of anticipated treatment for systemic infection including HIV
8. 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;
9. Marked instability of the cervical spine on resting lateral or flexion-extension radiographs;
10. Known allergy to device materials including titanium or polyetheretherketone (PEEK);
11. Segmental kyphosis of greater than 11 degrees at treatment or adjacent levels
12. Rheumatoid arthritis, lupus, or other autoimmune disease;
13. Any diseases or conditions that would preclude accurate clinical evaluation;
14. Daily, high-dose oral and/or inhaled steroid or a history of chronic use of high dose steroids;
15. Body Mass Index (BMI) \> 35
16. Smoking more than one pack of cigarettes per day;

Where this trial is running

Taichung, South Dist. and 12 other locations

• Chung Shan Medical University Hospital — Taichung, South Dist., Taiwan (Recruiting)
• Fu Jen Catholic University Hospital — New Taipei City, Taishan District, Taiwan (Recruiting)
• Taipei Municipal Wan Fang Hospital — Taipei, Wenshan Dist., Taiwan (Not_yet_recruiting)
• National Taiwan University Hospital Yunlin Branch — Douliu, Yunlin County, Taiwan (Recruiting)
• Taipei Medical University-Shuang Ho Hospital,Ministry of Health and Welfare — New Taipei City, Zhonghe District, Taiwan (Recruiting)
• MacKay Memorial Hospital — Taipei, Zhongshan, Taiwan (Recruiting)
• National Taiwan University Hospital — Taipei, Zhongzheng Dist., Taiwan (Recruiting)
• National Taiwan University Hospital Hsin-Chu Branch — Hsinchu, Taiwan (Recruiting)
• China Medical University Hospital — Taichung, Taiwan (Recruiting)
• Jen-Ai Hospital Dali Branch — Taichung, Taiwan (Recruiting)
• National Cheng Kung University Hospital — Tainan, Taiwan (Not_yet_recruiting)
• Min-Sheng General Hospital — Taoyuan, Taiwan (Recruiting)
• Chang Gung Memorial Hospital — Taoyuan, Taiwan (Not_yet_recruiting)

Study contacts

• Study coordinator: Dar-Ming Lai

Conditions Cervical Disc Degeneration; Cervical Spine; Interbody Fusion; Anterior Cervical Discectomy and Fusion