Trial of Unicompartmental Versus Total Knee Arthroplasty

November 9, 2022 updated by: Nancy Parks, Anderson Orthopaedic Research Institute

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

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

112

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Illinois
      • Chicago, Illinois, United States, 60612
        • Rush University Medical Center
    • Virginia
      • Alexandria, Virginia, United States, 22306
        • Anderson Orthopaedic Research Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: UKA
Medial unicompartmental knee arthroplasty
Procedure: Unicompartmental knee arthroplasty
Implant to replace the medial compartment of a patient with knee osteoarthritis
ACTIVE_COMPARATOR: TKA
Total knee arthroplasty
Procedure: Total knee arthroplasty
Implant to replace the knee joint of a patient with knee osteoarthritis

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Knee Society Score
Time Frame: 1 year
Functional outcome questionnaire ranging from 0-100, with 100 being best
1 year
Knee Society Score
Time Frame: 2 years
Functional knee outcome questionnaire ranging from 0-100, with 100 being best
2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Revision
Time Frame: 2 years
complication requiring revision surgery
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Anderson Orthopaedic Research Institute

Collaborators

Rush University Medical Center

Investigators

  • Principal Investigator: Kevin Fricka, MD, Anderson Orthopaedic Institute

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

May 22, 2018

Primary Completion (ANTICIPATED)

April 1, 2023

Study Completion (ANTICIPATED)

January 1, 2025

Study Registration Dates

First Submitted

December 21, 2017

First Submitted That Met QC Criteria

December 27, 2017

First Posted (ACTUAL)

December 28, 2017

Study Record Updates

Last Update Posted (ACTUAL)

November 14, 2022

Last Update Submitted That Met QC Criteria

November 9, 2022

Last Verified

November 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 17-2931

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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