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

Ewha Womans University logo

Ewha Womans University

Status and phase

Completed
Phase 4

Conditions

Osteoarthritis

Treatments

Device: low contact stress rotating platform mobile-bearing
Device: anatomic modular fixed-bearing

Study type

Interventional

Funder types

Other

Identifiers

NCT01361152
Fixed- and Mobile TKA

Details and patient eligibility

About

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

Full 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.

Enrollment

216 patients

Sex

All

Ages

29 to 50 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

216 participants in 2 patient groups

Fixed-bearing group
Experimental group
Description:
Fixed-bearing group
Treatment:
Device: anatomic modular fixed-bearing
Mobile-bearing group
Experimental group
Description:
Mobile-bearing group
Treatment:
Device: low contact stress rotating platform mobile-bearing

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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