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Comparison of Cage Versus Plate in One Level Cervical Disc Disease

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Chun Kee Chung, Seoul National University Hospital
ClinicalTrials.gov Identifier:
NCT01011569
First received: November 10, 2009
Last updated: April 19, 2013
Last verified: April 2013
History of Changes
  Purpose

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
Cervical Disc Disease

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Randomized Controlled Trial of Cage Versus Plate in One Level Cervical Disc Disease

Further study details as provided by Seoul National University Hospital:

Primary Outcome Measures:
  • Disc height ratio, cervical lordosis, bone fusion and segmental lordosis at the index level [ Time Frame: 1/3/6/12/24/36 months after operation ] [ Designated as safety issue: No ]

Estimated Enrollment: 80
Study Start Date: April 2004
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
cage
patient who underwent stand alone cage insertion after discectomy
plate
patient who underwent plate fixation and autologous ilia bone graft after discectomy

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.

  Eligibility

Ages Eligible for Study:   20 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

patient who needs surgery due to cervical disc disease

Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01011569

Locations
Korea, Republic of
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
  More Information

Publications:

Responsible Party: Chun Kee Chung, Professor, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT01011569     History of Changes
Other Study ID Numbers: CAP trial
Study First Received: November 10, 2009
Last Updated: April 19, 2013
Health Authority: Korea: Food and Drug Administration

Keywords provided by Seoul National University Hospital:
difference

Additional relevant MeSH terms:
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases

ClinicalTrials.gov processed this record on June 18, 2013