A Muti-Center Study Comparing 3 Procedures for Bi-level Cervical Spondylosis

NCT03358225 | Unknown DMC

• 1 other identifier: Hybrid007
• Study Type: observational
• Target: 198
• Locations: 0 countries
• Sites: N/A

Brief Summary

A muti-center study to compare the safety and efficacy of anterior cervical discectomy and fusion, cervical artificial disc replacement and hybrid surgery for bi-level cervical spondylosis.

Conditions

Cervical Spondylosis

Keywords

Hybrid surgery,ACDF,C-ADR,bi-level cervical spondylosis

Outcome Measures

Primary Outcomes (1)

• range of the motion of operative segments and adjacent segments

  Standard dynamic flexion and extension lateral cervical radiographs were obtained to evaluate range of motion of C2-C7 and operative segments and superior and inferior adjacent segments, cervical lordosis, and radiographic changes in adjacent segments.

  preoperatively, within 5 days after surgery, and at 6, and 12 months postoperatively

Secondary Outcomes (3)

• scores of the Japanese Orthopedic Association

  preoperatively, within 5 days after surgery, and at 6, and 12 months postoperatively

• scores of the Neck Disability Index

  preoperatively, within 5 days after surgery, and at 6, and 12 months postoperatively

• scores of the visual analog scale

  preoperatively, within 5 days after surgery, and at 6, and 12 months postoperatively

Study Arms (3)

Anterior Cervical Discectomy and Fusion

The patients undergoing anterior cervical discectomy and fusion surgery

Procedure: anterior cervical discectomy and fusion

Cervical Artificial Disc Replacement

The patients undergoing cervical artificial disc replacement surgery

Procedure: cervical artificial disc replacement

Hybrid surgery

The patients undergoing hybrid surgery(1-level ADR plus 1-level ACDF) surgery

Procedure: hybrid surgery

Interventions

anterior cervical discectomy and fusion PROCEDURE

The patients undergoing anterior cervical discectomy and fusion sugery

Anterior Cervical Discectomy and Fusion

cervical artificial disc replacement PROCEDURE

The patients undergoing cervical artificial disc replacement surgery

Cervical Artificial Disc Replacement

hybrid surgery PROCEDURE

The patients undergoing 1-level C-ADR plus 1-level ACDF surgery

Hybrid surgery

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

patients with bi-level cervical spondylosis

You may qualify if:

• (1) Cervical degenerative pathology with symptomatic radiculopathy or myelopathy at two consecutive segments from C3 to C7 which not responding to conservative treatment for 6 weeks. (2) Preoperative magnetic resonance imaging (MRI), complete cervical spine radiography and computed tomography (CT) showed anterior compressive pathology. (3) None or slight osteophyte at the posterior edge of vertebrae. (4) None significant spinal stenosis or posterior compression.

You may not qualify if:

• ossification of the posterior longitudinal ligament (OPLL), tumor, fracture, infection, history of cervical spine surgery, narrowing of the spinal canal, and any serious general illness. Cases with one or more than two segments requiring treatment were also excluded.

Sponsors & Collaborators

• Peking University People's Hospital: lead

Related Publications (5)

• Toledano M, Bartleson JD. Cervical spondylotic myelopathy. Neurol Clin. 2013 Feb;31(1):287-305. doi: 10.1016/j.ncl.2012.09.003.

  PMID: 23186905 BACKGROUND

• Lebl DR, Hughes A, Cammisa FP Jr, O'Leary PF. Cervical spondylotic myelopathy: pathophysiology, clinical presentation, and treatment. HSS J. 2011 Jul;7(2):170-8. doi: 10.1007/s11420-011-9208-1. Epub 2011 Jun 22.

  PMID: 22754419 BACKGROUND

• Veeravagu A, Cole T, Jiang B, Ratliff JK. Revision rates and complication incidence in single- and multilevel anterior cervical discectomy and fusion procedures: an administrative database study. Spine J. 2014 Jul 1;14(7):1125-31. doi: 10.1016/j.spinee.2013.07.474. Epub 2013 Oct 11.

  PMID: 24126076 BACKGROUND

• Jia Z, Mo Z, Ding F, He Q, Fan Y, Ruan D. Hybrid surgery for multilevel cervical degenerative disc diseases: a systematic review of biomechanical and clinical evidence. Eur Spine J. 2014 Aug;23(8):1619-32. doi: 10.1007/s00586-014-3389-5. Epub 2014 Jun 8.

  PMID: 24908252 BACKGROUND

• Lee MJ, Dumonski M, Phillips FM, Voronov LI, Renner SM, Carandang G, Havey RM, Patwardhan AG. Disc replacement adjacent to cervical fusion: a biomechanical comparison of hybrid construct versus two-level fusion. Spine (Phila Pa 1976). 2011 Nov 1;36(23):1932-9. doi: 10.1097/BRS.0b013e3181fc1aff.

  PMID: 21289581 BACKGROUND

MeSH Terms

Conditions

Spondylosis

Interventions

Gene Fusion

Condition Hierarchy (Ancestors)

Spinal Diseases; Bone Diseases; Musculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Recombination, Genetic; Genetic Phenomena

Study Officials

• LIU Haiying

  department of spinal surgery,PekingUPH

  PRINCIPAL INVESTIGATOR

Central Study Contacts

YU Guanjie, bachelor

CONTACT

18500234005; yuguanjieok@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: department of spinal surgery

Study Record Dates

• First Submitted: November 26, 2017
• First Posted: November 30, 2017
• Study Start: January 1, 2018
• Primary Completion: December 1, 2018
• Study Completion: December 1, 2018
• Last Updated: November 30, 2017

Record last verified: 2017-11

Data Sharing

• IPD Sharing: Will not share