Unicompartmental Knee Arthroplasty vs. High Tibial Osteotomy for Medial Knee Osteoarthritis (UNIKORN): a Study Protocol of a Randomized Controlled Trial (UNIKORN)
July 1, 2022 updated by: Juuso Siren, Töölö Hospital
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.
Study Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
100
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 Contact
- Name: Juuso Siren, MD
- Phone Number: 0407005858
- Email: juuso.siren@hus.fi
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
45 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 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: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Unicompartmental knee osteoarthritis
|
Medial Unicompartmental knee arthroplasty
|
|
Active Comparator: High tibial osteotomy
|
Medial open wedge high tibial osteotomy
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
KOOS
Time Frame: 1- year
|
1- year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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 (Anticipated)
November 1, 2022
Primary Completion (Anticipated)
December 1, 2024
Study Completion (Anticipated)
December 1, 2025
Study Registration Dates
First Submitted
June 28, 2022
First Submitted That Met QC Criteria
June 28, 2022
First Posted (Actual)
July 1, 2022
Study Record Updates
Last Update Posted (Actual)
July 6, 2022
Last Update Submitted That Met QC Criteria
July 1, 2022
Last Verified
July 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- HUS/1259/2019
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
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.