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

Cervical Spondylosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03358225
• Other study ID #: Hybrid007
• Status: Not yet recruiting
• Phase: N/A
• First received: November 26, 2017
• Last updated: November 26, 2017
• Start date: January 1, 2018
• Est. completion date: December 1, 2018

Study information

• Verified date: November 2017
• Source: Peking University People's Hospital
• Contact: YU Guanjie, bachelor
• Phone: 18500234005
• Email: yuguanjieok[@]163.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

Patients with bi-level cervical spondylosis undergoing anterior cervical discectomy and fusion, cervical artificial disc replacement and hybrid surgery in the muti-center hospital were retrospectively reviewed.The safety and efficacy were evaluated based on scores of the Neck Disability Index (NDI), visual analog scale (VAS), and Japanese Orthopedic Association (JOA) and the range of motion of both operative segments and adjacent segments,not only in the preoperative,but also in the 5 days,6 months,12 months and the 5 years after surgery.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 198
• Est. completion date: December 1, 2018
• Est. primary completion date: December 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 80 Years

Eligibility

Inclusion Criteria:

• (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.

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Cervical Spondylosis
• Spondylosis

Intervention

Procedure:
• anterior cervical discectomy and fusion
The patients undergoing anterior cervical discectomy and fusion sugery
• cervical artificial disc replacement
The patients undergoing cervical artificial disc replacement surgery
• hybrid surgery
The patients undergoing 1-level C-ADR plus 1-level ACDF surgery

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Peking University People's Hospital

References & Publications (5)

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. Review. — View Citation

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. — View Citation

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. — View Citation

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

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	scores of the Japanese Orthopedic Association	Clinical effects were evaluated based on scores of the Japanese Orthopedic Association (JOA)	preoperatively, within 5 days after surgery, and at 6, and 12 months postoperatively
Secondary	scores of the Neck Disability Index	Clinical effects were evaluated based on scores of the Neck Disability Index(NDI)	preoperatively, within 5 days after surgery, and at 6, and 12 months postoperatively
Secondary	scores of the visual analog scale	Clinical effects were evaluated based on scores of the visual analog scale(VAS)	preoperatively, within 5 days after surgery, and at 6, and 12 months postoperatively