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Comparison of Cage Versus Plate in One Level Cervical Disc Disease

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01011569
Enrollment
80
Registered
2009-11-11
Start date
2004-04-30
Completion date
2013-12-31
Last updated
2018-04-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cervical Disc Disease

Keywords

difference

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.

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.

Interventions

None listed

Sponsors

Seoul National University Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
20 Years to 70 Years
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.

Design outcomes

Primary

MeasureTime frame
Disc height ratio, cervical lordosis, bone fusion and segmental lordosis at the index level1/3/6/12/24/36 months after operation

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 13, 2026