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

Primary Purpose

Cervical Disc Degeneration

Status

Recruiting

Phase

Phase 4

Locations

Taiwan

Study Type

Interventional

Intervention

Z-Brace interbody fusion device

PEEK interbody fusion device

About this trial

This is an interventional treatment trial for Cervical Disc Degeneration focused on measuring Cervical Spine, Interbody Fusion, Anterior Cervical Discectomy and Fusion

Eligibility Criteria

20 Years - 69 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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;

Sites / Locations

Chung Shan Medical University HospitalRecruiting
Fu Jen Catholic University HospitalRecruiting
Taipei Municipal Wan Fang Hospital
National Taiwan University Hospital Yunlin BranchRecruiting
Taipei Medical University-Shuang Ho Hospital,Ministry of Health and WelfareRecruiting
MacKay Memorial HospitalRecruiting
National Taiwan University HospitalRecruiting
National Taiwan University Hospital Hsin-Chu BranchRecruiting
China Medical University HospitalRecruiting
Jen-Ai Hospital Dali BranchRecruiting
National Cheng Kung University Hospital
Min-Sheng General HospitalRecruiting
Chang Gung Memorial Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Investigational device (non-rigid) group

Control device (rigid) group

Arm Description

Use non-rigid (Titanium Alloy, Z-Brace, Baui Biotech) interbody fusion device.

Use rigid (PEEK) interbody fusion device .

Outcomes

Primary Outcome Measures

Change from baseline postoperative condition (if patients have major complications)

No adverse events (AEs) classified as major complications by Research Ethics Committee.

Change from baseline postoperative condition (if patients have subsequent surgeries)

No subsequent surgical intervention.

Change from baseline Subsidence and Fusion rate

Subsidence and fusion rate on radiological.

Change from baseline Adjacent range of motion

Adjacent range of motion on radiological.

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.

Secondary Outcome Measures

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 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.

Anxiety score

The Beck Anxiety Inventory (BAI). The minimum value is 0 and the maximum value is 63. Higher scores mean a worse outcome.

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.

Number of days using Non-steroidal anti-inflammatory analgesics(NSAIDs)

Depression Score

Beck Depression Inventory(BDI). The minimum value is 0 and the maximum value is 63. Higher scores mean a worse outcome.

Full Information

NCT ID

NCT04550923

First Posted

September 2, 2020

Last Updated

July 31, 2023

Sponsor

National Taiwan University Hospital

Collaborators

Baui Biotech Co., Ltd.

1. Study Identification

Unique Protocol Identification Number

NCT04550923

Brief Title

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

2. Study Status

Record Verification Date

July 2023

Overall Recruitment Status

Recruiting

Study Start Date

December 3, 2020 (Actual)

Primary Completion Date

June 30, 2023 (Actual)

Study Completion Date

June 30, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

National Taiwan University Hospital

Collaborators

Baui Biotech Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Cervical Disc Degeneration

Keywords

Cervical Spine, Interbody Fusion, Anterior Cervical Discectomy and Fusion

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

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)

Allocation

Randomized

Enrollment

180 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Investigational device (non-rigid) group

Arm Type

Experimental

Arm Description

Use non-rigid (Titanium Alloy, Z-Brace, Baui Biotech) interbody fusion device.

Arm Title

Control device (rigid) group

Arm Type

Active Comparator

Arm Description

Use rigid (PEEK) interbody fusion device .

Intervention Type

Combination Product

Intervention Name(s)

Z-Brace interbody fusion device

Intervention Description

Use non-rigid (Titanium Alloy, Z-Brace, Baui Biotech) interbody fusion device in Anterior Cervical Discectomy and Fusion (ACDF) surgery

Intervention Type

Combination Product

Intervention Name(s)

PEEK interbody fusion device

Intervention Description

Use rigid (PEEK) interbody fusion device in Anterior Cervical Discectomy and Fusion (ACDF) surgery

Primary Outcome Measure Information:

Title

Change from baseline postoperative condition (if patients have major complications)

Description

No adverse events (AEs) classified as major complications by Research Ethics Committee.

Time Frame

Patient were evaluated one month postoperatively, and 3, 6, 12, 18, and 24 months postoperatively.

Title

Change from baseline postoperative condition (if patients have subsequent surgeries)

Description

No subsequent surgical intervention.

Time Frame

Patient were evaluated one month postoperatively, and 3, 6, 12, 18, and 24 months postoperatively.

Title

Change from baseline Subsidence and Fusion rate

Description

Subsidence and fusion rate on radiological.

Time Frame

Patient were evaluated one month postoperatively, and 3, 6, 12, 18, and 24 months postoperatively.

Title

Change from baseline Adjacent range of motion

Description

Adjacent range of motion on radiological.

Time Frame

Patient were evaluated preoperatively, one month postoperatively, and 3, 6, 12, 18, and 24 months postoperatively.

Title

Change from baseline Neck Disability Index (NDI)

Description

Time Frame

Patient were evaluated preoperatively, one month postoperatively, and 3, 6, 12, 18, and 24 months postoperatively.

Secondary Outcome Measure Information:

Title

Visual analogue scale (neck and arm and chest pain)

Description

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.

Time Frame

Patient were evaluated preoperatively, one month postoperatively, and 3, 6, 12, 18, and 24 months postoperatively.

Title

Patient Satisfaction Questionnaire

Description

Time Frame

Patient were evaluated one month postoperatively, and 3, 6, 12, 18, and 24 months postoperatively.

Title

Anxiety score

Description

The Beck Anxiety Inventory (BAI). The minimum value is 0 and the maximum value is 63. Higher scores mean a worse outcome.

Time Frame

Patient were evaluated preoperatively, one month postoperatively, and 3, 6, 12, 18, and 24 months postoperatively.

Title

Short form-12 mental component scale and physical component scale (SF-12 MCS/PCS) score

Description

Time Frame

Patient were evaluated preoperatively, one month postoperatively, and 3, 6, 12, 18, and 24 months postoperatively.

Title

Number of days using Non-steroidal anti-inflammatory analgesics(NSAIDs)

Description

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.

Title

Depression Score

Description

Beck Depression Inventory(BDI). The minimum value is 0 and the maximum value is 63. Higher scores mean a worse outcome.

Time Frame

Patient were evaluated preoperatively, one month postoperatively, and 3, 6, 12, 18, and 24 months postoperatively.

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Maximum Age & Unit of Time

69 Years

Accepts Healthy Volunteers

Eligibility Criteria

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;

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Dar-Ming Lai

Phone

+886-2312-3456

Ext

65078

dmlai@ntu.edu.tw

First Name & Middle Initial & Last Name or Official Title & Degree

Fon-Yih Tsuang

Phone

+886-972651142

tsuangfy@gmail.com

Facility Information:

Facility Name

Chung Shan Medical University Hospital

City

Taichung

State/Province

South Dist.

ZIP/Postal Code

402

Country

Taiwan

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Se-Yi Chen

First Name & Middle Initial & Last Name & Degree

Se-Yi Chen

Facility Name

Fu Jen Catholic University Hospital

City

New Taipei City

State/Province

Taishan District

ZIP/Postal Code

243

Country

Taiwan

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Wei-Lung Tseng

Phone

+886-905301906

puddingj@gmail.com

First Name & Middle Initial & Last Name & Degree

Wei-Lung Tseng

Facility Name

Taipei Municipal Wan Fang Hospital

City

Taipei City

State/Province

Wenshan Dist.

ZIP/Postal Code

116

Country

Taiwan

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Yi-Jie Kuo

benkuo5@tmu.edu.tw

First Name & Middle Initial & Last Name & Degree

Ming-Hong Chen

First Name & Middle Initial & Last Name & Degree

Yi-Jie Kuo

First Name & Middle Initial & Last Name & Degree

Ming-Hong Chen

Facility Name

National Taiwan University Hospital Yunlin Branch

City

Douliu

State/Province

Yunlin County

ZIP/Postal Code

640

Country

Taiwan

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Yuan-Sen Chen

Phone

+886-5-5323911

First Name & Middle Initial & Last Name & Degree

Yuan-Sen Chen

Facility Name

Taipei Medical University-Shuang Ho Hospital,Ministry of Health and Welfare

City

New Taipei

State/Province

Zhonghe District

ZIP/Postal Code

23561

Country

Taiwan

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Chang-Jung Chiang

First Name & Middle Initial & Last Name & Degree

Chang-Jung Chiang

Facility Name

MacKay Memorial Hospital

City

Taipei City

State/Province

Zhongshan

ZIP/Postal Code

10449

Country

Taiwan

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Hsu-Chao Chen

Phone

+886-936099219

chenshiujau@gmail.com

First Name & Middle Initial & Last Name & Degree

Hsu-Chao Chen

Facility Name

National Taiwan University Hospital

City

Taipei

State/Province

Zhongzheng Dist.

ZIP/Postal Code

100

Country

Taiwan

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Dar-Ming Lai

Phone

+88623123456

Ext

65078

dmlai@ntu.edu.tw

First Name & Middle Initial & Last Name & Degree

Fon-Yih Tsuang

Phone

+886972651142

tsuangfy@gmail.com

First Name & Middle Initial & Last Name & Degree

Dar-Ming Lai

First Name & Middle Initial & Last Name & Degree

Fon-Yih Tsuang

First Name & Middle Initial & Last Name & Degree

Furen Xiao

First Name & Middle Initial & Last Name & Degree

Shih-Hung Yang

Facility Name

National Taiwan University Hospital Hsin-Chu Branch

City

Hsinchu

ZIP/Postal Code

300

Country

Taiwan

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Huan-Chih Wang

Phone

+886-972654379

jessehcwang@ntu.edu.tw

First Name & Middle Initial & Last Name & Degree

Huan-Chih Wang

Facility Name

China Medical University Hospital

City

Taichung

ZIP/Postal Code

404332

Country

Taiwan

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Chao-Hsuan Chen

Phone

+886-4-22052121

First Name & Middle Initial & Last Name & Degree

Sung-Tai Wei

Phone

+886-4-22052121

First Name & Middle Initial & Last Name & Degree

Chao-Hsuan Chen

First Name & Middle Initial & Last Name & Degree

Sung-Tai Wei

Facility Name

Jen-Ai Hospital Dali Branch

City

Taichung

ZIP/Postal Code

412

Country

Taiwan

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Yu-Tung Shih

First Name & Middle Initial & Last Name & Degree

Yu-Tung Shih

Facility Name

National Cheng Kung University Hospital

City

Tainan

Country

Taiwan

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Cheng-Li Lin

First Name & Middle Initial & Last Name & Degree

Cheng-Li Lin

Facility Name

Min-Sheng General Hospital

City

Taoyuan

ZIP/Postal Code

330

Country

Taiwan

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Shao Hua Ko

Phone

+886-975082212

M002013@e-ms.com.tw

First Name & Middle Initial & Last Name & Degree

Ming Yuan Chang

Phone

+886-966500038

arynancha@gmail.com

First Name & Middle Initial & Last Name & Degree

Ming Yuan Chang

First Name & Middle Initial & Last Name & Degree

Shao-Hua Ko

Facility Name

Chang Gung Memorial Hospital

City

Taoyuan

Country

Taiwan

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Yu-Cheng Yeh

Phone

03-319-6200

First Name & Middle Initial & Last Name & Degree

Yu-Cheng Yeh

First Name & Middle Initial & Last Name & Degree

Po-Liang Lai

12. IPD Sharing Statement

Citations:

PubMed Identifier

12897467

Citation

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.

Results Reference

background

PubMed Identifier

1440038

Citation

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.

Results Reference

background

PubMed Identifier

25982430

Citation

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.

Results Reference

background

PubMed Identifier

8408151

Citation

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.

Results Reference

background

PubMed Identifier

19262984

Citation

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.

Results Reference

background

PubMed Identifier

18846395

Citation

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.

Results Reference

background

PubMed Identifier

17221174

Citation

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.

Results Reference

background

PubMed Identifier

15260088

Citation

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.

Results Reference

background

PubMed Identifier

10436851

Citation

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.

Results Reference

background

PubMed Identifier

3775422

Citation

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.

Results Reference

background

PubMed Identifier

30415055

Citation

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.

Results Reference

background

PubMed Identifier

27771787

Citation

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.

Results Reference

background

PubMed Identifier

27295435

Citation

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.

Results Reference

background

PubMed Identifier

26872258

Citation

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.

Results Reference

background

PubMed Identifier

22960519

Citation

Ding D, Shaffrey ME. Cervical disk arthroplasty: patient selection. Clin Neurosurg. 2012;59:91-7. doi: 10.1227/NEU.0b013e31826b6fbe. No abstract available.

Results Reference

background

PubMed Identifier

19468885

Citation

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.

Results Reference

background

PubMed Identifier

28057595

Citation

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.

Results Reference

background

PubMed Identifier

31528438

Citation

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.

Results Reference

background

PubMed Identifier

12188968

Citation

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.

Results Reference

background

Links:

URL

https://doi.org/10.1016/S1359-6454(98)80035-9

Description

W. Bonfield MW, K.E. Tanner. Interfaces in analogue biomaterials. Acta Materialia. 1998;46（7）:2509-18.

Learn more about this trial

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

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