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

May 23, 2024 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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
180

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

16 years to 65 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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
National Taiwan University Hospital

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 3, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 30, 2023

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 30, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 2, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 9, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 16, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 24, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 23, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

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