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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 September 18, 2014