Comparison of Cage Versus Plate in One Level Cervical Disc Disease

Cervical Disc Disease Clinical Trial

Official title:

Randomized Controlled Trial of Cage Versus Plate in One Level Cervical Disc Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01011569
• Other study ID #: CAP trial
• Status: Completed
• First received: November 10, 2009
• Last updated: April 13, 2018
• Start date: April 2004
• Est. completion date: December 2013

Study information

• Verified date: April 2018
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

There are largely 2 surgical methods for one-level cervical disc disease; cage only and plate/graft. Even there are many reports about the efficacy of either cage only or plate/graft, prospective comparative study is few. The object of the present study is to present design of prospective study and to demonstrate preliminary result.

Description:

Prospective study was started from April 2004 after permission by our Institutional Review Board. Inclusion criteria were single cervical disc disease with radiculopathy/myelopathy. We excluded patients with severe spondylosis, multiple disc disease, overt instability, osteoporosis or previous cervical operation history. Operation method was randomized using the table of random sampling numbers. All operations were performed with standard anterior-medial approach. Two types of cages and 2 types of plates were used: cage, MC+ cage (LDR, Austin, Tx, USA) or Solis cage (Stryker, Kalamazoo, Michigan, USA); plate, Black stone (Orthofix, McKinney, Tx, USA) or Atlantis (Medtronic, Minneapolis, MN, USA). We checked neck disability index (NDI), neck visual analogue scale (VAS) and limb VAS before operation and 1/3/6/12/24/36 months after operation. Disc height ratio, cervical lordosis, bone fusion status and segmental lordosis at the index level were measured from X-rays and follow-up X-rays were obtained at before operation and 1/3/6/12/24/36 months after operation. The present prospective study was planned until 80 patients (cage n = 40, plate/graft n = 40) were enrolled.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: December 2013
• Est. primary completion date: October 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 70 Years

Eligibility

Inclusion Criteria:

• Inclusion criteria were single cervical disc disease with radiculopathy/myelopathy.

Exclusion Criteria:

• We excluded patients with severe spondylosis, multiple disc disease, overt instability, osteoporosis or previous cervical operation history.

Related Conditions & MeSH terms

• Cervical Disc Disease
• Intervertebral Disc Degeneration
• Intervertebral Disc Displacement
• Spinal Diseases

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (1)

Kim CH, Chung CK, Hahn S. Autologous iliac bone graft with anterior plating is advantageous over the stand-alone cage for segmental lordosis in single-level cervical disc disease. Neurosurgery. 2013 Feb;72(2):257-65; discussion 266. doi: 10.1227/NEU.0b013 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Disc height ratio, cervical lordosis, bone fusion and segmental lordosis at the index level		1/3/6/12/24/36 months after operation