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NCT03385759 Clinical Trial

Trial of Unicompartmental Versus Total Knee Arthroplasty

Osteo Arthritis Knee Clinical Trial

Official title:
A Prospective Randomized Trial of Unicompartmental Versus Total Knee Arthroplasty for the Treatment of Medial Compartment Osteoarthritis

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT03385759
Other study ID # 17-2931
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date May 22, 2018
Est. completion date January 2025

Study information
Verified date November 2022
Source Anderson Orthopaedic Research Institute
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study is a prospective, randomized trial to compare patient outcomes of unicompartmental knee arthroplasty (UKA) and total knee arthroplasty (TKA) for the treatment of medial compartment osteoarthritis.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 112
Est. completion date January 2025
Est. primary completion date April 1, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility Inclusion Criteria: - medial compartment osteoarthritis of the knee - knee flexion greater than greater than 90 degrees - flexion contracture of less than 10 degrees - varus deformity < 20 degrees - grade IV degeneration of the medial compartment Exclusion Criteria: - lateral compartment degenerative changes - previous lateral meniscectomy - anterior cruciate ligament deficiency - body mass index > 40 - inflammatory arthritis - history of septic arthritis - hemoglobin A1c > 8.0 - chronic liver disease - stage 3A or greater chronic renal disease - active IV drug abuse - patients requiring thromboembolic prophylaxis

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• Unicompartmental knee arthroplasty
Implant to replace the medial compartment of a patient with knee osteoarthritis
• Total knee arthroplasty
Implant to replace the knee joint of a patient with knee osteoarthritis

Locations
Country Name City State
United States Anderson Orthopaedic Research Institute Alexandria Virginia
United States Rush University Medical Center Chicago Illinois

Sponsors (2)
Lead Sponsor Collaborator
Anderson Orthopaedic Research Institute Rush University Medical Center

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Knee Society Score Functional outcome questionnaire ranging from 0-100, with 100 being best 1 year
Primary Knee Society Score Functional knee outcome questionnaire ranging from 0-100, with 100 being best 2 years
Secondary Revision complication requiring revision surgery 2 years
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