Comparison of Rigid and Non-Rigid Interbody Fusion Device for Cervical Degenerative Disc Disease in Adults
NCT ID: NCT04550923
Last Updated: 2024-05-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE4
180 participants
INTERVENTIONAL
2020-12-03
2025-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Investigational device (non-rigid) group
Use non-rigid (Titanium Alloy, Z-Brace, Baui Biotech) interbody fusion device.
Z-Brace interbody fusion device
Use non-rigid (Titanium Alloy, Z-Brace, Baui Biotech) interbody fusion device in Anterior Cervical Discectomy and Fusion (ACDF) surgery
Control device (rigid) group
Use rigid (PEEK) interbody fusion device .
PEEK interbody fusion device
Use rigid (PEEK) interbody fusion device in Anterior Cervical Discectomy and Fusion (ACDF) surgery
Interventions
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Z-Brace interbody fusion device
Use non-rigid (Titanium Alloy, Z-Brace, Baui Biotech) interbody fusion device in Anterior Cervical Discectomy and Fusion (ACDF) surgery
PEEK interbody fusion device
Use rigid (PEEK) interbody fusion device in Anterior Cervical Discectomy and Fusion (ACDF) surgery
Eligibility Criteria
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Inclusion Criteria
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
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;
20 Years
69 Years
ALL
No
Sponsors
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Baui Biotech Co., Ltd.
UNKNOWN
National Taiwan University Hospital
OTHER
Responsible Party
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Locations
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Chung Shan Medical University Hospital
Taichung, South Dist., Taiwan
Fu Jen Catholic University Hospital
New Taipei City, Taishan District, Taiwan
Taipei Municipal Wan Fang Hospital
Taipei, Wenshan Dist., Taiwan
National Taiwan University Hospital Yunlin Branch
Douliu, Yunlin County, Taiwan
Taipei Medical University-Shuang Ho Hospital,Ministry of Health and Welfare
New Taipei City, Zhonghe District, Taiwan
MacKay Memorial Hospital
Taipei, Zhongshan, Taiwan
National Taiwan University Hospital
Taipei, Zhongzheng Dist., Taiwan
National Taiwan University Hospital Hsin-Chu Branch
Hsinchu, , Taiwan
China Medical University Hospital
Taichung, , Taiwan
Jen-Ai Hospital Dali Branch
Taichung, , Taiwan
National Cheng Kung University Hospital
Tainan City, , Taiwan
Min-Sheng General Hospital
Taoyuan District, , Taiwan
Chang Gung Memorial Hospital
Taoyuan District, , Taiwan
Countries
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Central Contacts
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Facility Contacts
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Se-Yi Chen
Role: primary
Ming-Hong Chen
Role: backup
Yuan-Sen Chen
Role: primary
Chang-Jung Chiang
Role: primary
Chao-Hsuan Chen
Role: primary
Sung-Tai Wei
Role: backup
Yu-Tung Shih
Role: primary
Cheng-Li Lin
Role: primary
Yu-Cheng Yeh
Role: primary
References
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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.
Brodke 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.
Shriver 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.
Bohlman 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.
Sugawara 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.
Elsawaf 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.
Barsa 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.
Goffin 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.
Maiman 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.
Gore DR, Gardner GM, Sepic SB, Murray MP. Roentgenographic findings following anterior cervical fusion. Skeletal Radiol. 1986;15(7):556-9. doi: 10.1007/BF00361055.
Gao 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.
Ma 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.
Kuang 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.
Hu 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.
Ding D, Shaffrey ME. Cervical disk arthroplasty: patient selection. Clin Neurosurg. 2012;59:91-7. doi: 10.1227/NEU.0b013e31826b6fbe. No abstract available.
Jaramillo-de la Torre JJ, Grauer JN, Yue JJ. Update on cervical disc arthroplasty: where are we and where are we going? Curr Rev Musculoskelet Med. 2008 Jun;1(2):124-30. doi: 10.1007/s12178-008-9019-2.
Tahal D, Madhavan K, Chieng LO, Ghobrial GM, Wang MY. Metals in Spine. World Neurosurg. 2017 Apr;100:619-627. doi: 10.1016/j.wneu.2016.12.105. Epub 2017 Jan 3.
Epstein NE. A Review of Complication Rates for Anterior Cervical Diskectomy and Fusion (ACDF). Surg Neurol Int. 2019 Jun 7;10:100. doi: 10.25259/SNI-191-2019. eCollection 2019.
Goffin J, Casey A, Kehr P, Liebig K, Lind B, Logroscino C, Pointillart V, Van Calenbergh F, van Loon J. Preliminary clinical experience with the Bryan Cervical Disc Prosthesis. Neurosurgery. 2002 Sep;51(3):840-5; discussion 845-7. doi: 10.1227/00006123-200209000-00048.
Related Links
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W. Bonfield MW, K.E. Tanner. Interfaces in analogue biomaterials. Acta Materialia. 1998;46（7）:2509-18.
Liu JT, Chen WC, Wei HW. Biomechanical evaluation of a dynamic fusion cage design for cervical spine: A finite element study. Advances in Mechanical Engineering. 2017;9（3）:1-7.
Other Identifiers
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202006012RIPD
Identifier Type: -
Identifier Source: org_study_id
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