Clinical trial NCT04550923: Comparison of Rigid and Non-Rigid Interbody Fusion Device for Cervical Degenerative Disc Disease in Adults
Official title: Comparison of Rigid and Non-Rigid Interbody Fusion Device for Cervical Degenerative Disc Disease in Adults - A Randomized, Prospective, Multicenter Clinical Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Cervical Disc Degeneration
Keywords: Cervical Spine
Interbody Fusion
Anterior Cervical Discectomy and Fusion
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
Collaborators: name: Baui Biotech Co., Ltd.
First posted: 2020-09-16
Enrollment: 180
Sex: ALL
Minimum age (years): 20
Maximum age (years): 69
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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;

Primary outcomes:
measure: Change from baseline postoperative condition (if patients have major complications)
timeFrame: Patient were evaluated one month postoperatively, and 3, 6, 12, 18, and 24 months postoperatively.
measure: Change from baseline postoperative condition (if patients have subsequent surgeries)
timeFrame: Patient were evaluated one month postoperatively, and 3, 6, 12, 18, and 24 months postoperatively.
measure: Change from baseline Subsidence and Fusion rate
timeFrame: Patient were evaluated one month postoperatively, and 3, 6, 12, 18, and 24 months postoperatively.
measure: Change from baseline Adjacent range of motion
timeFrame: Patient were evaluated preoperatively, one month postoperatively, and 3, 6, 12, 18, and 24 months postoperatively.
measure: Change from baseline Neck Disability Index (NDI)
timeFrame: Patient were evaluated preoperatively, one month postoperatively, and 3, 6, 12, 18, and 24 months postoperatively.
Secondary outcomes:
measure: Visual analogue scale (neck and arm and chest pain)
timeFrame: Patient were evaluated preoperatively, one month postoperatively, and 3, 6, 12, 18, and 24 months postoperatively.
measure: Patient Satisfaction Questionnaire
timeFrame: Patient were evaluated one month postoperatively, and 3, 6, 12, 18, and 24 months postoperatively.
measure: Anxiety score
timeFrame: Patient were evaluated preoperatively, one month postoperatively, and 3, 6, 12, 18, and 24 months postoperatively.
measure: Short form-12 mental component scale and physical component scale (SF-12 MCS/PCS) score
timeFrame: Patient were evaluated preoperatively, one month postoperatively, and 3, 6, 12, 18, and 24 months postoperatively.
measure: Number of days using Non-steroidal anti-inflammatory analgesics(NSAIDs)
timeFrame: Patient were evaluated preoperatively, one month postoperatively, and 3, 6, 12, 18, and 24 months postoperatively.
measure: Depression Score
timeFrame: Patient were evaluated preoperatively, one month postoperatively, and 3, 6, 12, 18, and 24 months postoperatively.
Other outcomes:
Locations:
city: Taichung
country: Taiwan
facility: Chung Shan Medical University Hospital
state: South Dist.
city: New Taipei City
country: Taiwan
facility: Fu Jen Catholic University Hospital
state: Taishan District
city: Taipei City
country: Taiwan
facility: Taipei Municipal Wan Fang Hospital
state: Wenshan Dist.
city: Douliu
country: Taiwan
facility: National Taiwan University Hospital Yunlin Branch
state: Yunlin County
city: New Taipei
country: Taiwan
facility: Taipei Medical University-Shuang Ho Hospital,Ministry of Health and Welfare
state: Zhonghe District
city: Taipei City
country: Taiwan
facility: MacKay Memorial Hospital
state: Zhongshan
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
state: Zhongzheng Dist.
city: Hsinchu
country: Taiwan
facility: National Taiwan University Hospital Hsin-Chu Branch
city: Taichung
country: Taiwan
facility: China Medical University Hospital
city: Taichung
country: Taiwan
facility: Jen-Ai Hospital Dali Branch
city: Tainan
country: Taiwan
facility: National Cheng Kung University Hospital
city: Taoyuan
country: Taiwan
facility: Min-Sheng General Hospital
city: Taoyuan
country: Taiwan
facility: Chang Gung Memorial Hospital
Study officials:
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