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NCT05442242 Clinical Trial

Unicompartmental Knee Arthroplasty vs. High Tibial Osteotomy for Medial Knee Osteoarthritis (UNIKORN): a Study Protocol of a Randomized Controlled Trial

Knee Osteoarthritis Clinical Trial

— UNIKORN  

Official title:
Unicompartmental Knee Arthroplasty vs. High Tibial Osteotomy for Medial Knee Osteoarthritis (UNIKORN): a Study Protocol of a Randomized Controlled Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT05442242
Other study ID # HUS/1259/2019
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date November 2022
Est. completion date December 2025

Study information
Verified date July 2022
Source Töölö Hospital
Contact Juuso Siren, MD
Phone 0407005858
Email juuso.siren@hus.fi
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Unicompartmental knee arthroplasty (UKA) and High Tibial Osteotomy are both valid treatment options for isolated medial knee osteoarthritis. Literature to date is lacking high grade evidence of the outcomes between these procedures. This is a study protocol for randomized controlled trial comparing UKA vs HTO in late stage medial knee osteoarthritis.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 100
Est. completion date December 2025
Est. primary completion date December 2024
Accepts healthy volunteers No
Gender All
Age group 45 Years to 65 Years
Eligibility Inclusion Criteria: - Isolated KL 3-4 medial knee arthrosis - Varus > 3 degrees - Age 45-65 years Exclusion Criteria: - Post-traumatic arthrosis - Arthrosis in the lateral compartment more than KL grade I in MRI - Post- traumatic arthrosis - Instability - Malignancy Obesity

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• Unicompartmental knee arthroplasty
Medial Unicompartmental knee arthroplasty
• High tibial osteotomy
Medial open wedge high tibial osteotomy

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Töölö Hospital

Outcome
Type Measure Description Time frame Safety issue
Primary KOOS 1- year
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