NCT07257211

Brief Summary

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).

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
102

participants targeted

Target at P50-P75 for not_applicable

Timeline
57mo left

Started Jan 2026

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress7%
Jan 2026Jan 2031

First Submitted

Initial submission to the registry

November 20, 2025

Completed
12 days until next milestone

First Posted

Study publicly available on registry

December 2, 2025

Completed
1 month until next milestone

Study Start

First participant enrolled

January 1, 2026

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2028

Expected
3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2031

Last Updated

December 2, 2025

Status Verified

November 1, 2025

Enrollment Period

2 years

First QC Date

November 20, 2025

Last Update Submit

November 20, 2025

Conditions

Medial Knee Osteoarthritis

Keywords

unicompartmentalknee arthroplastypartial knee replacementtotal knee replacementrandomized controlled trialknee prosthesis

Outcome Measures

Primary Outcomes (1)

  • clinical functional outcome (KOOS)

    KOOS evaluates patient reported knee function, pain, symptoms, activities of daily living, and quality of life. Higher score indicates better outcomes.

    12 months

Secondary Outcomes (1)

  • complication rate within 12 months

    12 months

Study Arms (2)

UKA

ACTIVE COMPARATOR

patients receiving a unicompartmental knee arthroplasty

Procedure: unicompartmental knee arthroplasty

TKA

ACTIVE COMPARATOR

patients receiving a total knee arthroplasty

Procedure: total knee arthroplasty

Interventions

unicompartmental knee arthroplastyPROCEDURE

medial unicompartmental knee arthroplasty using standard surgical technique and routine postoperative care

UKA
total knee arthroplastyPROCEDURE

total knee arthroplasty using standard surgical technique and routine postoperative care

TKA

Eligibility Criteria

Age40 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department for orthopedics and traumatology of Medical University of Graz

Graz, 8036, Austria

Location

MeSH Terms

Interventions

Arthroplasty, Replacement, Knee

Intervention Hierarchy (Ancestors)

Arthroplasty, ReplacementArthroplastyOrthopedic ProceduresSurgical Procedures, OperativePlastic Surgery ProceduresProsthesis Implantation

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 20, 2025

First Posted

December 2, 2025

Study Start

January 1, 2026

Primary Completion (Estimated)

January 1, 2028

Study Completion (Estimated)

January 1, 2031

Last Updated

December 2, 2025

Record last verified: 2025-11

Locations

AU(1)