Cervical Disc DegenerationPhase 4NCT04550923
Comparison of Rigid and Non-Rigid Interbody Fusion Device for Cervical Degenerative Disc Disease in Adults
A Phase 4 study testing Z-Brace interbody fusion device and PEEK interbody fusion device in people with Cervical Disc Degeneration, run by National Taiwan University Hospital at 13 sites in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 69 years
- Conditions the study is for
- Cervical Disc Degeneration
- What is being tested?
- Z-Brace interbody fusion device and PEEK interbody fusion device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 13 sitesTaiwan
- Study dates
- 3 Dec 2020to 30 Jun 2025
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 69 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
Who cannot join
- 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;
Show all 16Show fewer
- 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;
Trial locations and contacts
13 sites in 1 country.
13 sites in 1 country
Taiwan13 sites, 13 recruiting
- Recruiting
National Taiwan University Hospital Yunlin Branch
Douliu, Yunlin County, 640
Yuan-Sen Chen, +886-5-5323911
Yuan-Sen Chen
- Recruiting
National Taiwan University Hospital Hsin-Chu Branch
Hsinchu, 300
Huan-Chih Wang, +886-972654379, jessehcwang@ntu.edu.tw
Huan-Chih Wang
- Recruiting
Fu Jen Catholic University Hospital
New Taipei City, Taishan District, 243
Wei-Lung Tseng, +886-905301906, puddingj@gmail.com
Wei-Lung Tseng
- Recruiting
Taipei Medical University-Shuang Ho Hospital,Ministry of Health and Welfare
New Taipei City, Zhonghe District, 23561
Chang-Jung Chiang
Chang-Jung Chiang
- Recruiting
Chung Shan Medical University Hospital
Taichung, South Dist., 402
Se-Yi Chen
Se-Yi Chen
- Recruiting
China Medical University Hospital
Taichung, 404332
Chao-Hsuan Chen, +886-4-22052121
Sung-Tai Wei, +886-4-22052121
- Recruiting
Jen-Ai Hospital Dali Branch
Taichung, 412
Yu-Tung Shih
Yu-Tung Shih
- Not yet recruiting
National Cheng Kung University Hospital
Tainan
Cheng-Li Lin
Cheng-Li Lin
- Not yet recruiting
Taipei Municipal Wan Fang Hospital
Taipei, Wenshan Dist., 116
Yi-Jie Kuo, benkuo5@tmu.edu.tw
Ming-Hong Chen
- Recruiting
MacKay Memorial Hospital
Taipei, Zhongshan, 10449
Hsu-Chao Chen, +886-936099219, chenshiujau@gmail.com
Hsu-Chao Chen
- Recruiting
National Taiwan University Hospital
Taipei, Zhongzheng Dist., 100
Dar-Ming Lai, +88623123456 ext. 65078, dmlai@ntu.edu.tw
Fon-Yih Tsuang, +886972651142, tsuangfy@gmail.com
- Recruiting
Min-Sheng General Hospital
Taoyuan, 330
Shao Hua Ko, +886-975082212, M002013@e-ms.com.tw
Ming Yuan Chang, +886-966500038, arynancha@gmail.com
- Not yet recruiting
Chang Gung Memorial Hospital
Taoyuan
Yu-Cheng Yeh, 03-319-6200
Yu-Cheng Yeh
About this study
Official title: Comparison of Rigid and Non-Rigid Interbody Fusion Device for Cervical Degenerative Disc Disease in Adults - A Randomized, Prospective, Multicenter Clinical Trial
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.
Read the 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.
- Conditions
- Cervical Disc Degeneration
- Being tested
- Z-Brace interbody fusion device, PEEK interbody fusion device
- Keywords
- Cervical Spine, Interbody Fusion, Anterior Cervical Discectomy and Fusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Z-Brace interbody fusion deviceCombination product
Use non-rigid (Titanium Alloy, Z-Brace, Baui Biotech) interbody fusion device in Anterior Cervical Discectomy and Fusion (ACDF) surgery
PEEK interbody fusion deviceCombination product
Use rigid (PEEK) interbody fusion device in Anterior Cervical Discectomy and Fusion (ACDF) surgery
| Study group | Role | What they receive |
|---|---|---|
| Investigational device (non-rigid) group | Experimental | Use non-rigid (Titanium Alloy, Z-Brace, Baui Biotech) interbody fusion device. Receives: Combination Product: Z-Brace interbody fusion device |
| Control device (rigid) group | Active comparator | Use rigid (PEEK) interbody fusion device . Receives: Combination Product: PEEK interbody fusion device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline postoperative condition (if patients have major complications)
No adverse events (AEs) classified as major complications by Research Ethics Committee.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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)
Measured: 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.
Measured: Patient were evaluated preoperatively, one month postoperatively, and 3, 6, 12, 18, and 24 months postoperatively.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2020
- Study start3 Dec 2020
- Primary completion30 Jun 2023
- Study completion30 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (19)Papers the sponsor has linked to this study.
- Other trials for Cervical Disc DegenerationStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Baui Biotech Co., Ltd.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04550923
- Sponsor's protocol ID
- 202006012RIPD
- Status last verified
- May 2024
- First submitted
- 2 Sep 2020
- Last updated
- 24 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Zdeblick TA, Phillips FM. Interbody cage devices. Spine (Phila Pa 1976). 2003 Aug 1;28(15 Suppl):S2-7. doi: 10.1097/01.BRS.0000076841.93570.78.
PubMed 12897467Brodke DS, Zdeblick TA. Modified Smith-Robinson procedure for anterior cervical discectomy and fusion. Spine (Phila Pa 1976). 1992 Oct;17(10 Suppl):S427-30. doi: 10.1097/00007632-199210001-00014.
PubMed 1440038Shriver MF, Lewis DJ, Kshettry VR, Rosenbaum BP, Benzel EC, Mroz TE. Pseudoarthrosis rates in anterior cervical discectomy and fusion: a meta-analysis. Spine J. 2015 Sep 1;15(9):2016-27. doi: 10.1016/j.spinee.2015.05.010. Epub 2015 May 15.
PubMed 25982430Bohlman HH, Emery SE, Goodfellow DB, Jones PK. Robinson anterior cervical discectomy and arthrodesis for cervical radiculopathy. Long-term follow-up of one hundred and twenty-two patients. J Bone Joint Surg Am. 1993 Sep;75(9):1298-307. doi: 10.2106/00004623-199309000-00005.
PubMed 8408151Sugawara T, Itoh Y, Hirano Y, Higashiyama N, Mizoi K. Long term outcome and adjacent disc degeneration after anterior cervical discectomy and fusion with titanium cylindrical cages. Acta Neurochir (Wien). 2009 Apr;151(4):303-9; discussion 309. doi: 10.1007/s00701-009-0217-5. Epub 2009 Mar 5.
PubMed 19262984Elsawaf A, Mastronardi L, Roperto R, Bozzao A, Caroli M, Ferrante L. Effect of cervical dynamics on adjacent segment degeneration after anterior cervical fusion with cages. Neurosurg Rev. 2009 Apr;32(2):215-24; discussion 224. doi: 10.1007/s10143-008-0164-2. Epub 2008 Oct 10.
PubMed 18846395Barsa P, Suchomel P. Factors affecting sagittal malalignment due to cage subsidence in standalone cage assisted anterior cervical fusion. Eur Spine J. 2007 Sep;16(9):1395-400. doi: 10.1007/s00586-006-0284-8. Epub 2007 Jan 13.
PubMed 17221174Goffin J, Geusens E, Vantomme N, Quintens E, Waerzeggers Y, Depreitere B, Van Calenbergh F, van Loon J. Long-term follow-up after interbody fusion of the cervical spine. J Spinal Disord Tech. 2004 Apr;17(2):79-85. doi: 10.1097/00024720-200404000-00001.
PubMed 15260088Maiman DJ, Kumaresan S, Yoganandan N, Pintar FA. Biomechanical effect of anterior cervical spine fusion on adjacent segments. Biomed Mater Eng. 1999;9(1):27-38.
PubMed 10436851Gore DR, Gardner GM, Sepic SB, Murray MP. Roentgenographic findings following anterior cervical fusion. Skeletal Radiol. 1986;15(7):556-9. doi: 10.1007/BF00361055.
PubMed 3775422Gao X, Yang Y, Liu H, Meng Y, Zeng J, Wu T, Hong Y. A Comparison of Cervical Disc Arthroplasty and Anterior Cervical Discectomy and Fusion in Patients with Two-Level Cervical Degenerative Disc Disease: 5-Year Follow-Up Results. World Neurosurg. 2019 Feb;122:e1083-e1089. doi: 10.1016/j.wneu.2018.10.231. Epub 2018 Nov 9.
PubMed 30415055Ma Z, Ma X, Yang H, Guan X, Li X. Anterior cervical discectomy and fusion versus cervical arthroplasty for the management of cervical spondylosis: a meta-analysis. Eur Spine J. 2017 Apr;26(4):998-1008. doi: 10.1007/s00586-016-4779-7. Epub 2016 Oct 22.
PubMed 27771787Kuang L, Chen Y, Wang B, Li L, Lu G. Cervical Disk Arthroplasty Versus Anterior Cervical Decompression and Fusion for the Treatment of 2-Level Cervical Spondylopathy: A Systematic Review and Meta-analysis. Clin Spine Surg. 2016 Nov;29(9):372-382. doi: 10.1097/BSD.0000000000000395.
PubMed 27295435Hu Y, Lv G, Ren S, Johansen D. Mid- to Long-Term Outcomes of Cervical Disc Arthroplasty versus Anterior Cervical Discectomy and Fusion for Treatment of Symptomatic Cervical Disc Disease: A Systematic Review and Meta-Analysis of Eight Prospective Randomized Controlled Trials. PLoS One. 2016 Feb 12;11(2):e0149312. doi: 10.1371/journal.pone.0149312. eCollection 2016.
PubMed 26872258Ding D, Shaffrey ME. Cervical disk arthroplasty: patient selection. Clin Neurosurg. 2012;59:91-7. doi: 10.1227/NEU.0b013e31826b6fbe. No abstract available.
PubMed 22960519
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Rigid and Non-Rigid Interbody Fusion Device for Cervical Degenerative Disc Disease in Adults - A Randomized, Prospective, Multicenter Clinical Trial
- ClinicalTrials.gov ID
- NCT04550923
- Acronym / sponsor ID
- 202006012RIPD
- Conditions
- Cervical Disc Degeneration
- Keywords
- Cervical Spine, Interbody Fusion, Anterior Cervical Discectomy and Fusion
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Collaborators
- Baui Biotech Co., Ltd.
- Study start
- 3 Dec 2020 (actual)
- Primary completion
- 30 Jun 2023 (actual)
- Study completion
- 30 Jun 2025 (estimated)
- First posted
- 16 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Investigational device (non-rigid) group | Experimental | Combination Product: Z-Brace interbody fusion deviceUse non-rigid (Titanium Alloy, Z-Brace, Baui Biotech) interbody fusion device. |
| Control device (rigid) group | Active comparator | Combination Product: PEEK interbody fusion deviceUse rigid (PEEK) interbody fusion device . |
Who may qualify
- Ages
- 20 to 69 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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;
Key exclusion criteria (16 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Z-Brace interbody fusion deviceUse non-rigid (Titanium Alloy, Z-Brace, Baui Biotech) interbody fusion device in Anterior Cervical Discectomy and Fusion (ACDF) surgery | Combination product | Investigational device (non-rigid) group |
| PEEK interbody fusion deviceUse rigid (PEEK) interbody fusion device in Anterior Cervical Discectomy and Fusion (ACDF) surgery | Combination product | Control device (rigid) group |
Primary outcome
Change from baseline postoperative condition (if patients have major complications)
Time frame: Patient were evaluated one month postoperatively, and 3, 6, 12, 18, and 24 months postoperatively.
No adverse events (AEs) classified as major complications by Research Ethics Committee.
Change from baseline postoperative condition (if patients have subsequent surgeries)
Time frame: Patient were evaluated one month postoperatively, and 3, 6, 12, 18, and 24 months postoperatively.
No subsequent surgical intervention.
Change from baseline Subsidence and Fusion rate
Time frame: Patient were evaluated one month postoperatively, and 3, 6, 12, 18, and 24 months postoperatively.
Subsidence and fusion rate on radiological.
Change from baseline Adjacent range of motion
Time frame: Patient were evaluated preoperatively, one month postoperatively, and 3, 6, 12, 18, and 24 months postoperatively.
Adjacent range of motion on radiological.
Change from baseline Neck Disability Index (NDI)
Time frame: Patient were evaluated preoperatively, one month postoperatively, and 3, 6, 12, 18, and 24 months postoperatively.
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.
6 secondary outcomes
Visual analogue scale (neck and arm and chest pain)
Time frame: Patient were evaluated preoperatively, one month postoperatively, and 3, 6, 12, 18, and 24 months postoperatively.
Patient Satisfaction Questionnaire
Time frame: Patient were evaluated one month postoperatively, and 3, 6, 12, 18, and 24 months postoperatively.
Anxiety score
Time frame: 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
Time frame: 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)
Time frame: Patient were evaluated preoperatively, one month postoperatively, and 3, 6, 12, 18, and 24 months postoperatively.
Depression Score
Time frame: Patient were evaluated preoperatively, one month postoperatively, and 3, 6, 12, 18, and 24 months postoperatively.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 May 2024.
- Background: PubMed 12897467Zdeblick TA, Phillips FM. Interbody cage devices. Spine (Phila Pa 1976). 2003 Aug 1;28(15 Suppl):S2-7. doi: 10.1097/01.BRS.0000076841.93570.78.
- Background: PubMed 1440038Brodke DS, Zdeblick TA. Modified Smith-Robinson procedure for anterior cervical discectomy and fusion. Spine (Phila Pa 1976). 1992 Oct;17(10 Suppl):S427-30. doi: 10.1097/00007632-199210001-00014.
- Background: PubMed 25982430Shriver MF, Lewis DJ, Kshettry VR, Rosenbaum BP, Benzel EC, Mroz TE. Pseudoarthrosis rates in anterior cervical discectomy and fusion: a meta-analysis. Spine J. 2015 Sep 1;15(9):2016-27. doi: 10.1016/j.spinee.2015.05.010. Epub 2015 May 15.
- Background: PubMed 8408151Bohlman HH, Emery SE, Goodfellow DB, Jones PK. Robinson anterior cervical discectomy and arthrodesis for cervical radiculopathy. Long-term follow-up of one hundred and twenty-two patients. J Bone Joint Surg Am. 1993 Sep;75(9):1298-307. doi: 10.2106/00004623-199309000-00005.
- Background: PubMed 19262984Sugawara T, Itoh Y, Hirano Y, Higashiyama N, Mizoi K. Long term outcome and adjacent disc degeneration after anterior cervical discectomy and fusion with titanium cylindrical cages. Acta Neurochir (Wien). 2009 Apr;151(4):303-9; discussion 309. doi: 10.1007/s00701-009-0217-5. Epub 2009 Mar 5.
- Background: PubMed 18846395Elsawaf A, Mastronardi L, Roperto R, Bozzao A, Caroli M, Ferrante L. Effect of cervical dynamics on adjacent segment degeneration after anterior cervical fusion with cages. Neurosurg Rev. 2009 Apr;32(2):215-24; discussion 224. doi: 10.1007/s10143-008-0164-2. Epub 2008 Oct 10.
- Background: PubMed 17221174Barsa P, Suchomel P. Factors affecting sagittal malalignment due to cage subsidence in standalone cage assisted anterior cervical fusion. Eur Spine J. 2007 Sep;16(9):1395-400. doi: 10.1007/s00586-006-0284-8. Epub 2007 Jan 13.
- Background: PubMed 15260088Goffin J, Geusens E, Vantomme N, Quintens E, Waerzeggers Y, Depreitere B, Van Calenbergh F, van Loon J. Long-term follow-up after interbody fusion of the cervical spine. J Spinal Disord Tech. 2004 Apr;17(2):79-85. doi: 10.1097/00024720-200404000-00001.
- Background: PubMed 10436851Maiman DJ, Kumaresan S, Yoganandan N, Pintar FA. Biomechanical effect of anterior cervical spine fusion on adjacent segments. Biomed Mater Eng. 1999;9(1):27-38.
- Background: PubMed 3775422Gore DR, Gardner GM, Sepic SB, Murray MP. Roentgenographic findings following anterior cervical fusion. Skeletal Radiol. 1986;15(7):556-9. doi: 10.1007/BF00361055.
- Background: PubMed 30415055Gao X, Yang Y, Liu H, Meng Y, Zeng J, Wu T, Hong Y. A Comparison of Cervical Disc Arthroplasty and Anterior Cervical Discectomy and Fusion in Patients with Two-Level Cervical Degenerative Disc Disease: 5-Year Follow-Up Results. World Neurosurg. 2019 Feb;122:e1083-e1089. doi: 10.1016/j.wneu.2018.10.231. Epub 2018 Nov 9.
- Background: PubMed 27771787Ma Z, Ma X, Yang H, Guan X, Li X. Anterior cervical discectomy and fusion versus cervical arthroplasty for the management of cervical spondylosis: a meta-analysis. Eur Spine J. 2017 Apr;26(4):998-1008. doi: 10.1007/s00586-016-4779-7. Epub 2016 Oct 22.
- W. Bonfield MW, K.E. Tanner. Interfaces in analogue biomaterials. Acta Materialia. 1998;46（7）:2509-18.Link provided by the sponsor.
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Assessing Microbiome in Primary Anterior Cervical Fusion Patients
Cervical Stenosis, Myelopathy
Active, not recruiting
Anterior Cervical Disectomy And Fusion Using The Tritanium® C Anterior Cervical Cage For One Or Two-Levels
Cervical Disc Herniation, Cervical Disc Degeneration
RecruitingObservational study
PMCF Study Fortilink-SC
Degenerative Disc Disease in Cervical Spine, Stenosis Cervical Spine
Enrolling by invitation
Physiotherapy and Osteopathic Treatment for Pain in the Cervical and Lumbar Spine and Temporomandibular Joints
Disc Degenerative Disease, Spine Degeneration
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
13 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Z-Brace interbody fusion device and PEEK interbody fusion device in people with Cervical Disc Degeneration, run by National Taiwan University Hospital at 13 sites in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dar-Ming Lai (+886-2312-3456 ext. 65078, dmlai@ntu.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline postoperative condition (if patients have major complications) (time frame: Patient were evaluated one month postoperatively, and 3, 6, 12, 18, and 24 months postoperatively.). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04550923, which also lists 19 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 May 2024.