Comparison of Rigid and Non-Rigid Interbody Fusion Device for Cervical Degenerative Disc Disease in Adults

December 20, 2023 updated by: National Taiwan University Hospital

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Estimated)

180

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Taiwan
      • Hsinchu, Taiwan, 300
        • Recruiting
        • National Taiwan University Hospital Hsin-Chu Branch
        • Contact:
        • Principal Investigator:
          • Huan-Chih Wang
      • Taichung, Taiwan, 404332
        • Recruiting
        • China Medical University Hospital
        • Contact:
          • Chao-Hsuan Chen
          • Phone Number: +886-4-22052121
        • Contact:
          • Sung-Tai Wei
          • Phone Number: +886-4-22052121
        • Principal Investigator:
          • Chao-Hsuan Chen
        • Sub-Investigator:
          • Sung-Tai Wei
      • Taichung, Taiwan, 412
        • Recruiting
        • Jen-Ai Hospital Dali Branch
        • Contact:
          • Yu-Tung Shih
        • Principal Investigator:
          • Yu-Tung Shih
      • Tainan, Taiwan
        • Not yet recruiting
        • National Cheng Kung University Hospital
        • Contact:
          • Cheng-Li Lin
        • Principal Investigator:
          • Cheng-Li Lin
      • Taoyuan, Taiwan
        • Not yet recruiting
        • Chang Gung Memorial Hospital
        • Contact:
          • Yu-Cheng Yeh
          • Phone Number: 03-319-6200
        • Principal Investigator:
          • Yu-Cheng Yeh
        • Sub-Investigator:
          • Po-Liang Lai
      • Taoyuan, Taiwan, 330
        • Recruiting
        • Min-Sheng General Hospital
        • Contact:
        • Contact:
        • Principal Investigator:
          • Ming Yuan Chang
        • Sub-Investigator:
          • Shao-Hua Ko
    • South Dist.
      • Taichung, South Dist., Taiwan, 402
        • Recruiting
        • Chung Shan Medical University Hospital
        • Contact:
          • Se-Yi Chen
        • Principal Investigator:
          • Se-Yi Chen
    • Taishan District
      • New Taipei City, Taishan District, Taiwan, 243
        • Recruiting
        • Fu Jen Catholic University Hospital
        • Contact:
        • Principal Investigator:
          • Wei-Lung Tseng
    • Wenshan Dist.
      • Taipei City, Wenshan Dist., Taiwan, 116
        • Not yet recruiting
        • Taipei Municipal Wan Fang Hospital
        • Contact:
        • Contact:
          • Ming-Hong Chen
        • Principal Investigator:
          • Yi-Jie Kuo
        • Sub-Investigator:
          • Ming-Hong Chen
    • Yunlin County
      • Douliu, Yunlin County, Taiwan, 640
        • Recruiting
        • National Taiwan University Hospital Yunlin Branch
        • Contact:
          • Yuan-Sen Chen
          • Phone Number: +886-5-5323911
        • Principal Investigator:
          • Yuan-Sen Chen
    • Zhonghe District
      • New Taipei, Zhonghe District, Taiwan, 23561
        • Recruiting
        • Taipei Medical University-Shuang Ho Hospital,Ministry of Health and Welfare
        • Contact:
          • Chang-Jung Chiang
        • Principal Investigator:
          • Chang-Jung Chiang
    • Zhongshan
      • Taipei City, Zhongshan, Taiwan, 10449
        • Recruiting
        • Mackay Memorial Hospital
        • Contact:
        • Principal Investigator:
          • Hsu-Chao Chen
    • Zhongzheng Dist.
      • Taipei, Zhongzheng Dist., Taiwan, 100
        • Recruiting
        • National Taiwan University Hospital
        • Principal Investigator:
          • Dar-Ming Lai
        • Contact:
        • Contact:
        • Sub-Investigator:
          • Fon-Yih Tsuang
        • Sub-Investigator:
          • Furen Xiao
        • Sub-Investigator:
          • Shih-Hung Yang

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 67 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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;

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Investigational device (non-rigid) group
Use non-rigid (Titanium Alloy, Z-Brace, Baui Biotech) interbody fusion device.
Combination product: Z-Brace interbody fusion device
Use non-rigid (Titanium Alloy, Z-Brace, Baui Biotech) interbody fusion device in Anterior Cervical Discectomy and Fusion (ACDF) surgery
Active Comparator: Control device (rigid) group
Use rigid (PEEK) interbody fusion device .
Combination product: PEEK interbody fusion device
Use rigid (PEEK) interbody fusion device in Anterior Cervical Discectomy and Fusion (ACDF) surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline postoperative condition (if patients have major complications)
Time Frame: Patient were evaluated one month postoperatively, and 3, 6, 12, 18, and 24 months postoperatively.
No adverse events (AEs) classified as major complications by Research Ethics Committee.
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)
Time Frame: Patient were evaluated one month postoperatively, and 3, 6, 12, 18, and 24 months postoperatively.
No subsequent surgical intervention.
Patient were evaluated one month postoperatively, and 3, 6, 12, 18, and 24 months postoperatively.
Change from baseline Subsidence and Fusion rate
Time Frame: Patient were evaluated one month postoperatively, and 3, 6, 12, 18, and 24 months postoperatively.
Subsidence and fusion rate on radiological.
Patient were evaluated one month postoperatively, and 3, 6, 12, 18, and 24 months postoperatively.
Change from baseline Adjacent range of motion
Time Frame: Patient were evaluated preoperatively, one month postoperatively, and 3, 6, 12, 18, and 24 months postoperatively.
Adjacent range of motion on radiological.
Patient were evaluated preoperatively, one month postoperatively, and 3, 6, 12, 18, and 24 months postoperatively.
Change from baseline Neck Disability Index (NDI)
Time Frame: Patient were evaluated preoperatively, one month postoperatively, and 3, 6, 12, 18, and 24 months postoperatively.
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.
Patient were evaluated preoperatively, one month postoperatively, and 3, 6, 12, 18, and 24 months postoperatively.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Visual analogue scale (neck and arm and chest pain)
Time Frame: Patient were evaluated preoperatively, one month postoperatively, and 3, 6, 12, 18, and 24 months postoperatively.

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.
Patient were evaluated preoperatively, one month postoperatively, and 3, 6, 12, 18, and 24 months postoperatively.
Patient Satisfaction Questionnaire
Time Frame: Patient were evaluated one month postoperatively, and 3, 6, 12, 18, and 24 months postoperatively.
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.
Patient were evaluated one month postoperatively, and 3, 6, 12, 18, and 24 months postoperatively.
Anxiety score
Time Frame: Patient were evaluated preoperatively, one month postoperatively, and 3, 6, 12, 18, and 24 months postoperatively.
The Beck Anxiety Inventory (BAI). The minimum value is 0 and the maximum value is 63. Higher scores mean a worse outcome.
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
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. 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.
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)
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)
Patient were evaluated preoperatively, one month postoperatively, and 3, 6, 12, 18, and 24 months postoperatively.
Depression Score
Time Frame: Patient were evaluated preoperatively, one month postoperatively, and 3, 6, 12, 18, and 24 months postoperatively.
Beck Depression Inventory(BDI). The minimum value is 0 and the maximum value is 63. Higher scores mean a worse outcome.
Patient were evaluated preoperatively, one month postoperatively, and 3, 6, 12, 18, and 24 months postoperatively.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Taiwan University Hospital

Collaborators

Baui Biotech Co., Ltd.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 3, 2020

Primary Completion (Actual)

June 30, 2023

Study Completion (Estimated)

June 30, 2025

Study Registration Dates

First Submitted

September 2, 2020

First Submitted That Met QC Criteria

September 9, 2020

First Posted (Actual)

September 16, 2020

Study Record Updates

Last Update Posted (Actual)

December 22, 2023

Last Update Submitted That Met QC Criteria

December 20, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 202006012RIPD

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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