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

May 17, 2011
October 4, 2011
April 1993
March 1996   (final data collection date for primary outcome measure)
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
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 mean follow up of 16.8 years
Complete list of historical versions of study NCT01361152 on ClinicalTrials.gov Archive Site
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.
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 mean follow up of 16.8 years.
Not Provided
Not Provided
 
Long-Term Comparison of Fixed- and Mobile-Bearing Total Knee Arthroplasties (TKAs) in Patients With OA ≤50 Years Old
Long-Term Comparison of Fixed- and Mobile-Bearing Total Knee Arthroplasties in Patients With Osteoarthritis Younger Than Fifty Years of Age

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

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.

Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Osteoarthritis
  • Device: anatomic modular fixed-bearing
    anatomic modular (AMK; DePuy) fixed-bearing prosthesis
    Other Name: AMK
  • Device: low contact stress rotating platform mobile-bearing
    low contact stress rotating platform (LCS RP; DePuy) mobile-bearing prosthesis
    Other Name: LCS RP
  • Experimental: Fixed-bearing group
    Fixed-bearing group
    Intervention: Device: anatomic modular fixed-bearing
  • Experimental: Mobile-bearing group
    Mobile-bearing group
    Intervention: Device: low contact stress rotating platform mobile-bearing
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
216
March 2011
March 1996   (final data collection date for primary outcome measure)

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
Both
29 Years to 50 Years
No
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
 
NCT01361152
Fixed- and Mobile TKA
No
Young Hoo Kim, Ewha Womans University
Ewha Womans University
Not Provided
Study Director: Young-Hoo Kim, MD Ewha Womans University Mokdong Hospital
Ewha Womans University
October 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP