Actively Recruiting
Comparison of Rigid and Non-Rigid Interbody Fusion Device for Cervical Degenerative Disc Disease in Adults
Led by National Taiwan University Hospital · Updated on 2024-05-24
180
Participants Needed
13
Research Sites
238 weeks
Total Duration
On this page
Sponsors
N
National Taiwan University Hospital
Lead Sponsor
B
Baui Biotech Co., Ltd.
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Comparison of Rigid and Non-Rigid Interbody Fusion Device for Cervical Degenerative Disc Disease in Adults
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 20 to 69 years
- Symptomatic cervical degenerative disc disease in one or two levels between C3 and C7 with radiculopathy or myeloradiculopathy and/or decreased muscle strength and/or abnormal sensation and/or abnormal reflexes
- Diagnosis confirmed by CT, MRI, or X-ray
- Neck Disability Index (NDI) score of 30 or higher out of 100
- Symptoms not improved after at least 6 weeks of non-operative treatment or progressive symptoms despite treatment
- No prior surgical procedures or fusions at the operative cervical levels
- Physically and mentally able and willing to follow the study protocol
- Signed informed consent form
You will not qualify if you...
- Does not meet the approved surgical indication for ACDF
- Surgery required at more than two vertebral levels
- Immobile cervical spine levels between C1 and C7 for any reason
- Prior surgery or fusion at the operative cervical level
- Osteoporosis with T-score less than -1.5
- Paget's disease, osteomalacia, or other metabolic bone diseases except osteoporosis
- Active infection at the surgical site or systemic infection including HIV
- Active malignancy within the last 5 years except certain skin cancers
- Marked cervical spine instability on imaging
- Known allergy to titanium or PEEK materials
- Segmental kyphosis greater than 11 degrees at treatment or adjacent levels
- Rheumatoid arthritis, lupus, or other autoimmune diseases
- Conditions that would interfere with accurate clinical evaluation
- Daily high-dose steroid use or history of chronic high-dose steroids
- Body Mass Index (BMI) over 35
- Smoking more than one pack of cigarettes per day
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 13 locations
1
Chung Shan Medical University Hospital
Taichung, South Dist., Taiwan, 402
Actively Recruiting
2
Fu Jen Catholic University Hospital
New Taipei City, Taishan District, Taiwan, 243
Actively Recruiting
3
Taipei Municipal Wan Fang Hospital
Taipei, Wenshan Dist., Taiwan, 116
Not Yet Recruiting
4
National Taiwan University Hospital Yunlin Branch
Douliu, Yunlin County, Taiwan, 640
Actively Recruiting
5
Taipei Medical University-Shuang Ho Hospital,Ministry of Health and Welfare
New Taipei City, Zhonghe District, Taiwan, 23561
Actively Recruiting
6
MacKay Memorial Hospital
Taipei, Zhongshan, Taiwan, 10449
Actively Recruiting
7
National Taiwan University Hospital
Taipei, Zhongzheng Dist., Taiwan, 100
Actively Recruiting
8
National Taiwan University Hospital Hsin-Chu Branch
Hsinchu, Taiwan, 300
Actively Recruiting
9
China Medical University Hospital
Taichung, Taiwan, 404332
Actively Recruiting
10
Jen-Ai Hospital Dali Branch
Taichung, Taiwan, 412
Actively Recruiting
11
National Cheng Kung University Hospital
Tainan, Taiwan
Not Yet Recruiting
12
Min-Sheng General Hospital
Taoyuan, Taiwan, 330
Actively Recruiting
13
Chang Gung Memorial Hospital
Taoyuan, Taiwan
Not Yet Recruiting
Research Team
D
Dar-Ming Lai
CONTACT
F
Fon-Yih Tsuang
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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