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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

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01361152
Enrollment
216
Registered
2011-05-26
Start date
1993-04-30
Completion date
2011-03-31
Last updated
2011-10-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Osteoarthritis

Keywords

total knee arthroplasty, fixed-bearing, mobile-bearing, long-term

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

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.

Interventions

DEVICEanatomic modular fixed-bearing

anatomic modular (AMK; DePuy) fixed-bearing prosthesis

DEVICElow contact stress rotating platform mobile-bearing

low contact stress rotating platform (LCS RP; DePuy) mobile-bearing prosthesis

Sponsors

Ewha Womans University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
29 Years to 50 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Improvement in Knee Society Knee Score18 yearschange in knee score will be compared with initial score, until follow up of 18 years

Secondary

MeasureTime frameDescription
Improvement in the range of motion18 yearschange in the range of motion of knee joint will be compared with the initial value, until follow up of 18 years.

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026