Partial vs Total Knee Replacement for Medial Knee Osteoarthritis: a Prospective Randomized Controlled Study (UKA vs TKA)

November 20, 2025 updated by: Medical University of Graz

Unicompartimental vs Total Knee Arthroplasty for Medial Knee Osteoarthritis: a Prospective, Ramdomized, Controlled Study

The goal of this clinical trial is to learn whether partial knee replacement (unicompartmental knee arthroplasty, UKA) or total knee replacement (total knee arthroplasty, TKA) leads to better clinical and functional outcomes in adults with medial knee osteoarthritis who are candidates for knee arthroplasty.

The main questions the study aims to answer are:

  • Does UKA or TKA result in better patient-reported outcomes, such as knee pain, function, and quality of life (measured by Oxford Knee Score, WOMAC, and Knee Society Score)?
  • Does UKA or TKA lead to differences in complications or revision rates during follow-up?

Researchers will compare UKA to TKA to see whether one procedure provides superior postoperative recovery, knee function, and long-term outcomes under standard clinical care conditions.

Participants will:

  • Receive either a unicompartmental or total knee replacement, assigned by randomization.
  • Undergo routine postoperative examinations, including standardized questionnaires (e.g., Oxford Knee Score, WOMAC, Knee Society Score, VAS).
  • Attend follow-up visits at standard clinical intervals (e.g., 6 weeks, 6 months, 1 year, 2 years, and beyond).

Study Overview

Detailed Description

Medial knee osteoarthritis is a common degenerative joint disease that often leads to significant pain, loss of function, and reduced quality of life. When conservative treatments are no longer effective, surgical joint replacement is a standard therapeutic option. Two established procedures are unicompartmental knee arthroplasty (UKA), which replaces the diseased medial compartment, and total knee arthroplasty (TKA). Both procedures are widely used, but it remains unclear which option provides better outcomes for patients who specifically present with isolated medial osteoarthritis.

This prospective, randomized, controlled clinical trial aims to systematically compare the functional, radiological, and patient-reported outcomes of UKA and TKA performed under routine clinical care conditions. The study is conducted at the Department of Orthopaedics and Traumatology at the Medical University of Graz. Adult patients with isolated medial knee osteoarthritis who meet established clinical and radiographic criteria for knee arthroplasty are eligible for participation.

All surgical procedures are performed using standard techniques and implants currently approved and used in routine practice. Postoperative follow-up follows the usual clinical schedule (e.g., 6 weeks, 6 months, 1 year, 2 years), with additional long-term clinical and radiological assessments as part of institutional standard care. During these visits, participants complete validated patient-reported outcome measures, including the Oxford Knee Score, WOMAC, Knee Society Score, Forgotten Joint Score, and Visual Analog Scale for pain. Radiographs are collected to assess implant position and alignment.

The study seeks to determine whether one of the two surgical approaches results in superior knee function, less postoperative pain, faster recovery, or lower complication and revision rates. Findings from this trial may support evidence-based decision-making for surgeons and patients considering knee arthroplasty for isolated medial knee osteoarthritis.

Study Type

Interventional

Enrollment (Estimated)

102

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

      • Graz, Austria, 8036
        • Department for orthopedics and traumatology of Medical University of Graz
        • Contact:

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • written consent, 4th degree medial osteoarthritis, max 1st degree lateral osteoarthritis, max. 2nd degree osteoarthritis in patellofemoral joint

Exclusion Criteria:

  • from 2nd degree lateral osteoarthritis, from 3nd degree osteoarthritis in patellofemoral joint, non-compensatable varus or valgus misalignment above 10 degrees, non-consent, age under 40 / over 90, st.p. fracture of the femur and or tibi, infection, st.p. joint replacement or osteotomy in the area of the knee joint, simultaneus bilateral care, pregnany

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 Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: UKA
patients receiving a unicompartmental knee arthroplasty
medial unicompartmental knee arthroplasty using standard surgical technique and routine postoperative care
Active Comparator: TKA
patients receiving a total knee arthroplasty
total knee arthroplasty using standard surgical technique and routine postoperative care

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
clinical functional outcome (KOOS)
Time Frame: 12 months
KOOS evaluates patient reported knee function, pain, symptoms, activities of daily living, and quality of life. Higher score indicates better outcomes.
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
complication rate within 12 months
Time Frame: 12 months
include infection, thromboembolic events, reintervention, and other adverse events
12 months

Collaborators and Investigators

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

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 (Estimated)

January 1, 2026

Primary Completion (Estimated)

January 1, 2028

Study Completion (Estimated)

January 1, 2031

Study Registration Dates

First Submitted

November 20, 2025

First Submitted That Met QC Criteria

November 20, 2025

First Posted (Actual)

December 2, 2025

Study Record Updates

Last Update Posted (Actual)

December 2, 2025

Last Update Submitted That Met QC Criteria

November 20, 2025

Last Verified

November 1, 2025

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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