Trial of Unicompartmental Versus Total Knee Arthroplasty
A Prospective Randomized Trial of Unicompartmental Versus Total Knee Arthroplasty for the Treatment of Medial Compartment Osteoarthritis
1 other identifier
interventional
112
1 country
2
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started May 2018
Longer than P75 for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 21, 2017
CompletedFirst Posted
Study publicly available on registry
December 28, 2017
CompletedStudy Start
First participant enrolled
May 22, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2025
CompletedNovember 14, 2022
November 1, 2022
4.9 years
December 21, 2017
November 9, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Knee Society Score
Functional outcome questionnaire ranging from 0-100, with 100 being best
1 year
Knee Society Score
Functional knee outcome questionnaire ranging from 0-100, with 100 being best
2 years
Secondary Outcomes (1)
Revision
2 years
Study Arms (2)
UKA
ACTIVE COMPARATORMedial unicompartmental knee arthroplasty
TKA
ACTIVE COMPARATORTotal knee arthroplasty
Interventions
Implant to replace the medial compartment of a patient with knee osteoarthritis
Implant to replace the knee joint of a patient with knee osteoarthritis
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Rush University Medical Center
Chicago, Illinois, 60612, United States
Anderson Orthopaedic Research Institute
Alexandria, Virginia, 22306, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Kevin Fricka, MD
Anderson Orthopaedic Institute
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Sr. Project Director
Study Record Dates
First Submitted
December 21, 2017
First Posted
December 28, 2017
Study Start
May 22, 2018
Primary Completion
April 1, 2023
Study Completion
January 1, 2025
Last Updated
November 14, 2022
Record last verified: 2022-11
Data Sharing
- IPD Sharing
- Will not share