Trial of Unicompartmental Versus Total Knee Arthroplasty

Study Purpose

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 Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years - 75 Years
Gender All
More Inclusion & Exclusion Criteria

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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT03385759
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

N/A
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Anderson Orthopaedic Research Institute
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Kevin Fricka, MD
Principal Investigator Affiliation Anderson Orthopaedic Institute
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

OtherOther
Overall Status Enrolling by invitation
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Osteo Arthritis Knee
Arms & Interventions

Arms

Active Comparator: UKA

Medial unicompartmental knee arthroplasty

Active Comparator: TKA

Total knee arthroplasty

Interventions

Procedure: - Unicompartmental knee arthroplasty

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

Procedure: - Total knee arthroplasty

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

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Rush University Medical Center, Chicago, Illinois

Status

Address

Rush University Medical Center

Chicago, Illinois, 60612

Anderson Orthopaedic Research Institute, Alexandria, Virginia

Status

Address

Anderson Orthopaedic Research Institute

Alexandria, Virginia, 22306