NCT05442242

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.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P75+ for not_applicable knee-osteoarthritis

Timeline
Completed

Started Nov 2022

Longer than P75 for not_applicable knee-osteoarthritis

Status
unknown

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

First Submitted

Initial submission to the registry

June 28, 2022

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 1, 2022

Completed
4 months until next milestone

Study Start

First participant enrolled

November 1, 2022

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2024

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2025

Completed
Last Updated

July 6, 2022

Status Verified

July 1, 2022

Enrollment Period

2.1 years

First QC Date

June 28, 2022

Last Update Submit

July 1, 2022

Conditions

Knee Osteoarthritis

Outcome Measures

Primary Outcomes (1)

  • KOOS

    1- year

Study Arms (2)

Unicompartmental knee osteoarthritis

ACTIVE COMPARATOR
Procedure: Unicompartmental knee arthroplasty

High tibial osteotomy

ACTIVE COMPARATOR
Procedure: High tibial osteotomy

Interventions

Unicompartmental knee arthroplastyPROCEDURE

Medial Unicompartmental knee arthroplasty

Unicompartmental knee osteoarthritis
High tibial osteotomyPROCEDURE

Medial open wedge high tibial osteotomy

High tibial osteotomy

Eligibility Criteria

Age45 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Isolated KL 3-4 medial knee arthrosis
  • Varus \> 3 degrees
  • Age 45-65 years

You may not qualify if:

  • Post-traumatic arthrosis
  • Arthrosis in the lateral compartment more than KL grade I in MRI
  • Post- traumatic arthrosis
  • Instability
  • Malignancy Obesity

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Siren J, Ramo L, Rantasalo M, Komulainen O, Skants N, Reito A, Kosola J, Lindahl J. Unicompartmental knee arthroplasty vs. high tibial osteotomy for medial knee osteoarthritis (UNIKORN): a study protocol of a randomized controlled trial. Trials. 2023 Apr 5;24(1):256. doi: 10.1186/s13063-023-07263-7.

    PMID: 37016454DERIVED

MeSH Terms

Conditions

Osteoarthritis, Knee

Interventions

Arthroplasty, Replacement, Knee

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Intervention Hierarchy (Ancestors)

Arthroplasty, ReplacementArthroplastyOrthopedic ProceduresSurgical Procedures, OperativePlastic Surgery ProceduresProsthesis Implantation

Central Study Contacts

Juuso Siren, MD

CONTACT

0407005858juuso.siren@hus.fi

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

June 28, 2022

First Posted

July 1, 2022

Study Start

November 1, 2022

Primary Completion

December 1, 2024

Study Completion

December 1, 2025

Last Updated

July 6, 2022

Record last verified: 2022-07

Data Sharing

IPD Sharing
Will not share