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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Cervical Disc Degeneration

Intervention / Treatment
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* Combination Product: Z-Brace interbody fusion device
* Combination Product: PEEK interbody fusion device


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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; Exclusion Criteria: 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 Smoking more than one pack of cigarettes per day;

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 69 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Investigational device (non-rigid) group<br>Use non-rigid (Titanium Alloy, Z-Brace, Baui Biotech) interbody fusion device. | Combination Product: Z-Brace interbody fusion device<br>* Use non-rigid (Titanium Alloy, Z-Brace, Baui Biotech) interbody fusion device in Anterior Cervical Discectomy and Fusion (ACDF) surgery<br>|
| Active Comparator: Control device (rigid) group<br>Use rigid (PEEK) interbody fusion device . | Combination Product: PEEK interbody fusion device<br>* Use rigid (PEEK) interbody fusion device in Anterior Cervical Discectomy and Fusion (ACDF) surgery<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual analogue scale (neck and arm and chest pain) | 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 | 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 | 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 | 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) | 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 | 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. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cervical Spine, Interbody Fusion, Anterior Cervical Discectomy and Fusion