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

Cervical Disc Degeneration Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04550923
• Other study ID #: 202006012RIPD
• Status: Recruiting
• Phase: Phase 4
• Start date: December 3, 2020
• Est. completion date: June 30, 2025

Study information

• Verified date: December 2023
• Source: National Taiwan University Hospital
• Contact: Dar-Ming Lai
• Phone: +886-2312-3456
• Email: dmlai[@]ntu.edu.tw
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 180
• Est. completion date: June 30, 2025
• Est. primary completion date: June 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 69 Years

Eligibility

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;

Related Conditions & MeSH terms

• Cervical Disc Degeneration
• Intervertebral Disc Degeneration

Intervention

Combination Product:
• 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

Locations

Country	Name	City	State
Taiwan	National Taiwan University Hospital Yunlin Branch	Douliu	Yunlin County
Taiwan	National Taiwan University Hospital Hsin-Chu Branch	Hsinchu
Taiwan	Taipei Medical University-Shuang Ho Hospital,Ministry of Health and Welfare	New Taipei	Zhonghe District
Taiwan	Fu Jen Catholic University Hospital	New Taipei City	Taishan District
Taiwan	China Medical University Hospital	Taichung
Taiwan	Chung Shan Medical University Hospital	Taichung	South Dist.
Taiwan	Jen-Ai Hospital Dali Branch	Taichung
Taiwan	National Cheng Kung University Hospital	Tainan
Taiwan	National Taiwan University Hospital	Taipei	Zhongzheng Dist.
Taiwan	MacKay Memorial Hospital	Taipei City	Zhongshan
Taiwan	Taipei Municipal Wan Fang Hospital	Taipei City	Wenshan Dist.
Taiwan	Chang Gung Memorial Hospital	Taoyuan
Taiwan	Min-Sheng General Hospital	Taoyuan

Sponsors (2)

Lead Sponsor	Collaborator
National Taiwan University Hospital	Baui Biotech Co., Ltd.

Country where clinical trial is conducted

Taiwan, 

References & Publications (19)

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. — View 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. — View 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. — View Citation

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

* Note: There are 19 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.

External Links

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