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

Status: Recruiting
Location: See all (13) locations...
Intervention Type: Combination product
Study Type: Interventional
Study Phase: Phase 4
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 20
Maximum Age: 69
Healthy Volunteers: f
View:

• 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;

Locations
Other Locations
Taiwan
National Taiwan University Hospital Yunlin Branch
RECRUITING
Douliu
National Taiwan University Hospital Hsin-Chu Branch
RECRUITING
Hsinchu
Fu Jen Catholic University Hospital
RECRUITING
New Taipei City
Taipei Medical University-Shuang Ho Hospital,Ministry of Health and Welfare
RECRUITING
New Taipei City
China Medical University Hospital
RECRUITING
Taichung
Chung Shan Medical University Hospital
RECRUITING
Taichung
Jen-Ai Hospital Dali Branch
RECRUITING
Taichung
National Cheng Kung University Hospital
NOT_YET_RECRUITING
Tainan City
MacKay Memorial Hospital
RECRUITING
Taipei
National Taiwan University Hospital
RECRUITING
Taipei
Taipei Municipal Wan Fang Hospital
NOT_YET_RECRUITING
Taipei
Chang Gung Memorial Hospital
NOT_YET_RECRUITING
Taoyuan District
Min-Sheng General Hospital
RECRUITING
Taoyuan District
Contact Information
Primary
Dar-Ming Lai
dmlai@ntu.edu.tw
+886-2312-3456
Backup
Fon-Yih Tsuang
tsuangfy@gmail.com
+886-972651142
Time Frame
Start Date: 2020-12-03
Estimated Completion Date: 2025-06-30
Participants
Target number of participants: 180
Treatments
Experimental: Investigational device (non-rigid) group
Use non-rigid (Titanium Alloy, Z-Brace, Baui Biotech) interbody fusion device.
Active_comparator: Control device (rigid) group
Use rigid (PEEK) interbody fusion device .
Related Therapeutic Areas
Sponsors
Leads: National Taiwan University Hospital
Collaborators: Baui Biotech Co., Ltd.

This content was sourced from clinicaltrials.gov