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

NCT04550923 | Recruiting Phase 4

• 1 other identifier: 202006012RIPD
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 13

Brief 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.

Conditions

Cervical Disc Degeneration

Keywords

Cervical Spine; Interbody Fusion; Anterior Cervical Discectomy and Fusion

Outcome Measures

Primary Outcomes (5)

• Change from baseline postoperative condition (if patients have major complications)

  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)

  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

  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

  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)

  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 Outcomes (6)

• Visual analogue scale (neck and arm and chest pain)

  Patient were evaluated preoperatively, one month postoperatively, and 3, 6, 12, 18, and 24 months postoperatively.

• Patient Satisfaction Questionnaire

  Patient were evaluated one month postoperatively, and 3, 6, 12, 18, and 24 months postoperatively.

• Anxiety score

  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

  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.

Study Arms (2)

Investigational device (non-rigid) group

EXPERIMENTAL

Use non-rigid (Titanium Alloy, Z-Brace, Baui Biotech) interbody fusion device.

Combination Product: Z-Brace interbody fusion device

Control device (rigid) group

ACTIVE COMPARATOR

Use rigid (PEEK) interbody fusion device .

Combination Product: PEEK interbody fusion device

Interventions

Z-Brace interbody fusion device COMBINATION_PRODUCT

Use non-rigid (Titanium Alloy, Z-Brace, Baui Biotech) interbody fusion device in Anterior Cervical Discectomy and Fusion (ACDF) surgery

Investigational device (non-rigid) group

PEEK interbody fusion device COMBINATION_PRODUCT

Use rigid (PEEK) interbody fusion device in Anterior Cervical Discectomy and Fusion (ACDF) surgery

Control device (rigid) group

Eligibility Criteria

• Age: 20 Years - 69 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• 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;
• 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;
• Marked instability of the cervical spine on resting lateral or flexion-extension radiographs;
• Known allergy to device materials including titanium or polyetheretherketone (PEEK);
• Segmental kyphosis of greater than 11 degrees at treatment or adjacent levels
• Rheumatoid arthritis, lupus, or other autoimmune disease;
• Any diseases or conditions that would preclude accurate clinical evaluation;
• Daily, high-dose oral and/or inhaled steroid or a history of chronic use of high dose steroids;
• Body Mass Index (BMI) \> 35

Sponsors & Collaborators

• National Taiwan University Hospital: lead
• Baui Biotech Co., Ltd.: collaborator

Study Sites (13)

Chung Shan Medical University Hospital

Taichung, South Dist., 402, Taiwan

RECRUITING

Fu Jen Catholic University Hospital

New Taipei City, Taishan District, 243, Taiwan

RECRUITING

Taipei Municipal Wan Fang Hospital

Taipei, Wenshan Dist., 116, Taiwan

NOT YET RECRUITING

National Taiwan University Hospital Yunlin Branch

Douliu, Yunlin County, 640, Taiwan

RECRUITING

Taipei Medical University-Shuang Ho Hospital,Ministry of Health and Welfare

New Taipei City, Zhonghe District, 23561, Taiwan

RECRUITING

MacKay Memorial Hospital

Taipei, Zhongshan, 10449, Taiwan

RECRUITING

National Taiwan University Hospital

Taipei, Zhongzheng Dist., 100, Taiwan

RECRUITING

National Taiwan University Hospital Hsin-Chu Branch

Hsinchu, 300, Taiwan

RECRUITING

China Medical University Hospital

Taichung, 404332, Taiwan

RECRUITING

Jen-Ai Hospital Dali Branch

Taichung, 412, Taiwan

RECRUITING

National Cheng Kung University Hospital

Tainan, Taiwan

NOT YET RECRUITING

Min-Sheng General Hospital

Taoyuan District, 330, Taiwan

RECRUITING

Chang Gung Memorial Hospital

Taoyuan District, Taiwan

NOT YET RECRUITING

Related Publications (19)

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Related Links

• W. Bonfield MW, K.E. Tanner. Interfaces in analogue biomaterials. Acta Materialia. 1998;46（7）:2509-18.
• Liu JT, Chen WC, Wei HW. Biomechanical evaluation of a dynamic fusion cage design for cervical spine: A finite element study. Advances in Mechanical Engineering. 2017;9（3）:1-7.

Central Study Contacts

Dar-Ming Lai

CONTACT

+886-2312-3456; dmlai@ntu.edu.tw

Fon-Yih Tsuang

CONTACT

+886-972651142; tsuangfy@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: September 2, 2020
• First Posted: September 16, 2020
• Study Start: December 3, 2020
• Primary Completion: June 30, 2023
• Study Completion: June 30, 2025
• Last Updated: May 24, 2024

Record last verified: 2024-05

Locations

TW (13)