Trial of Unicompartmental Versus Total Knee Arthroplasty

NCT ID: NCT03385759

Last Updated: 2022-11-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

112 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-05-22

Study Completion Date

2025-01-31

Brief Summary

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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.

Detailed Description

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Conditions

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Osteo Arthritis Knee

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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UKA

Medial unicompartmental knee arthroplasty

Group Type ACTIVE_COMPARATOR

Unicompartmental knee arthroplasty

Intervention Type PROCEDURE

Implant to replace the medial compartment of a patient with knee osteoarthritis

TKA

Total knee arthroplasty

Group Type ACTIVE_COMPARATOR

Total knee arthroplasty

Intervention Type PROCEDURE

Implant to replace the knee joint of a patient with knee osteoarthritis

Interventions

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Unicompartmental knee arthroplasty

Implant to replace the medial compartment of a patient with knee osteoarthritis

Intervention Type PROCEDURE

Total knee arthroplasty

Implant to replace the knee joint of a patient with knee osteoarthritis

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Rush University Medical Center

OTHER

Sponsor Role collaborator

Anderson Orthopaedic Research Institute

OTHER

Sponsor Role lead

Responsible Party

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Nancy Parks

Sr. Project Director

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Kevin Fricka, MD

Role: PRINCIPAL_INVESTIGATOR

Anderson Orthopaedic Institute

Locations

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Rush University Medical Center

Chicago, Illinois, United States

Site Status

Anderson Orthopaedic Research Institute

Alexandria, Virginia, United States

Site Status

Countries

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United States

Other Identifiers

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17-2931

Identifier Type: -

Identifier Source: org_study_id

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