Long-Term Comparison of Fixed- and Mobile-Bearing Total Knee Arthroplasties (TKAs) in Patients With OA ≤50 Years Old

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Young Hoo Kim, Ewha Womans University
ClinicalTrials.gov Identifier:
NCT01361152
First received: May 17, 2011
Last updated: October 4, 2011
Last verified: October 2011
  Purpose

The purpose of the prospective study was to evaluate the minimum fifteen year follow-up of prospective total knee arthroplasties performed in patients younger than fifty years of age with osteoarthritis, using fixed- and mobile-bearing knee prostheses in the same patients, to compare

  1. functional scores
  2. rates of radiographic failure
  3. revision rates
  4. survivorship

Condition Intervention Phase
Osteoarthritis
Device: anatomic modular fixed-bearing
Device: low contact stress rotating platform mobile-bearing
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Long-Term Comparison of Fixed- and Mobile-Bearing Total Knee Arthroplasties in Patients With Osteoarthritis Younger Than Fifty Years of Age

Resource links provided by NLM:


Further study details as provided by Ewha Womans University:

Primary Outcome Measures:
  • Improvement in Knee Society Knee Score [ Time Frame: 18 years ] [ Designated as safety issue: No ]
    change in knee score will be compared with initial score, until follow up of 18 years


Secondary Outcome Measures:
  • Improvement in the range of motion [ Time Frame: 18 years ] [ Designated as safety issue: No ]
    change in the range of motion of knee joint will be compared with the initial value, until follow up of 18 years.


Enrollment: 216
Study Start Date: April 1993
Study Completion Date: March 2011
Primary Completion Date: March 1996 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Fixed-bearing group
Fixed-bearing group
Device: anatomic modular fixed-bearing
anatomic modular (AMK; DePuy) fixed-bearing prosthesis
Other Name: AMK
Experimental: Mobile-bearing group
Mobile-bearing group
Device: low contact stress rotating platform mobile-bearing
low contact stress rotating platform (LCS RP; DePuy) mobile-bearing prosthesis
Other Name: LCS RP

Detailed Description:

The randomized prospective comparison of fixed- and mobile-bearing total knee designs in the same patients younger than fifty years of age is limited. The purpose of this study was to compare the long-term clinical and radiographic results of fixed- and mobile-bearing total knee arthroplasties in patients younger than fifty years of age with osteoarthritis.

  Eligibility

Ages Eligible for Study:   29 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • End-stage osteoarthritis of the knee joint requiring total knee arthroplasty with bilateral disease

Exclusion Criteria:

  • Inflammatory disease
  • Patient with other Lower extremity disease which may affect functional outcome
  • Neurologic disease effecting patients lower extremity
  • Revision surgery
  • Patient not medically cleared for bilateral surgery
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01361152

Locations
Korea, Republic of
Ewha Womans University Mokdong Hosptial
Seoul, Korea, Republic of, 158-710
Sponsors and Collaborators
Ewha Womans University
Investigators
Study Director: Young-Hoo Kim, MD Ewha Womans University Mokdong Hospital
  More Information

No publications provided

Responsible Party: Young Hoo Kim, Professor and Director, Ewha Womans University
ClinicalTrials.gov Identifier: NCT01361152     History of Changes
Other Study ID Numbers: Fixed- and Mobile TKA
Study First Received: May 17, 2011
Last Updated: October 4, 2011
Health Authority: Korea: Food and Drug Administration

Keywords provided by Ewha Womans University:
total knee arthroplasty
fixed-bearing
mobile-bearing
long-term

Additional relevant MeSH terms:
Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases

ClinicalTrials.gov processed this record on April 15, 2014