Back to resultsUnicompartmental Knee Arthroplasty vs. High Tibial Osteotomy for Medial Knee Osteoarthritis (UNIKORN): a Study Protocol of a Randomized Controlled Trial (UNIKORN)
Primary Purpose
Knee Osteoarthritis
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Unicompartmental knee arthroplasty
High tibial osteotomy
Sponsored by
About this trial
This is an interventional treatment trial for Knee Osteoarthritis
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Unicompartmental knee osteoarthritis
High tibial osteotomy
Arm Description
Outcomes
Primary Outcome Measures
KOOS
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05442242
Brief Title
Unicompartmental Knee Arthroplasty vs. High Tibial Osteotomy for Medial Knee Osteoarthritis (UNIKORN): a Study Protocol of a Randomized Controlled Trial
Acronym
UNIKORN
Official Title
Unicompartmental Knee Arthroplasty vs. High Tibial Osteotomy for Medial Knee Osteoarthritis (UNIKORN): a Study Protocol of a Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
July 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
November 2022 (Anticipated)
Primary Completion Date
December 2024 (Anticipated)
Study Completion Date
December 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Töölö Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Knee Osteoarthritis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Unicompartmental knee osteoarthritis
Arm Type
Active Comparator
Arm Title
High tibial osteotomy
Arm Type
Active Comparator
Intervention Type
Procedure
Intervention Name(s)
Unicompartmental knee arthroplasty
Intervention Description
Medial Unicompartmental knee arthroplasty
Intervention Type
Procedure
Intervention Name(s)
High tibial osteotomy
Intervention Description
Medial open wedge high tibial osteotomy
Primary Outcome Measure Information:
Title
KOOS
Time Frame
1- year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Juuso Siren, MD
Phone
0407005858
Email
juuso.siren@hus.fi
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Unicompartmental Knee Arthroplasty vs. High Tibial Osteotomy for Medial Knee Osteoarthritis (UNIKORN): a Study Protocol of a Randomized Controlled Trial
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