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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01361152
Recruitment Status : Completed
First Posted : May 26, 2011
Last Update Posted : October 5, 2011
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:

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 or disease Intervention/treatment Phase
Osteoarthritis Device: anatomic modular fixed-bearing Device: low contact stress rotating platform mobile-bearing Phase 4

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.

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 216 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (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
Study Start Date : April 1993
Primary Completion Date : March 1996
Study Completion Date : March 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

Primary Outcome Measures :
  1. Improvement in Knee Society Knee Score [ Time Frame: 18 years ]
    change in knee score will be compared with initial score, until follow up of 18 years


Secondary Outcome Measures :
  1. Improvement in the range of motion [ Time Frame: 18 years ]
    change in the range of motion of knee joint will be compared with the initial value, until follow up of 18 years.


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   29 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Posted: May 26, 2011    Key Record Dates
Last Update Posted: October 5, 2011
Last Verified: October 2011

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

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