Comparison of Cage Versus Plate in One Level Cervical Disc Disease

• Sponsor: Seoul National University Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT01011569
• Collaborator: (none)
• Enrollment: 80
• Location: 1
• Duration (Months): 116
• Patients Per Site Per Month: 0.7

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Cervical Disc Disease

Detailed 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.

Study Design

• Study Type: Observational
• Anticipated Enrollment: 80 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Randomized Controlled Trial of Cage Versus Plate in One Level Cervical Disc Disease
• Study Start Date: Apr 1, 2004
• Actual Primary Completion Date: Oct 1, 2013
• Actual Study Completion Date: Dec 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
cage patient who underwent stand alone cage insertion after discectomy
plate patient who underwent plate fixation and autologous ilia bone graft after discectomy

Outcome Measures

Primary Outcome Measures

1. Disc height ratio, cervical lordosis, bone fusion and segmental lordosis at the index level [1/3/6/12/24/36 months after operation]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years to 70 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Seoul National University Hospital	Seoul		Korea, Republic of	110-744

Sponsors and Collaborators

• Seoul National University Hospital

Investigators

• Principal Investigator: Chun Kee Chung, professor, Seoul National University Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Chun Kee Chung, Professor, Seoul National University Hospital
• ClinicalTrials.gov Identifier: NCT01011569
• Other Study ID Numbers: CAP trial
• First Posted: Nov 11, 2009
• Last Update Posted: Apr 17, 2018
• Last Verified: Apr 1, 2018

• Keywords provided by Chun Kee Chung, Professor, Seoul National University Hospital: difference
• Additional relevant MeSH terms: Spinal Diseases; Intervertebral Disc Displacement; Intervertebral Disc Degeneration

Study Results

No Results Posted as of Apr 17, 2018