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

NCT ID: NCT05442242

Last Updated: 2022-07-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-11-30

Study Completion Date

2025-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Knee Osteoarthritis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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Unicompartmental knee osteoarthritis

Group Type ACTIVE_COMPARATOR

Unicompartmental knee arthroplasty

Intervention Type PROCEDURE

Medial Unicompartmental knee arthroplasty

High tibial osteotomy

Group Type ACTIVE_COMPARATOR

High tibial osteotomy

Intervention Type PROCEDURE

Medial open wedge high tibial osteotomy

Interventions

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Unicompartmental knee arthroplasty

Medial Unicompartmental knee arthroplasty

Intervention Type PROCEDURE

High tibial osteotomy

Medial open wedge high tibial osteotomy

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

45 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Töölö Hospital

OTHER

Sponsor Role lead

Responsible Party

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Juuso Siren

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Central Contacts

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Juuso Siren, MD

Role: CONTACT

0407005858

References

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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.

Reference Type DERIVED
PMID: 37016454 (View on PubMed)

Other Identifiers

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HUS/1259/2019

Identifier Type: -

Identifier Source: org_study_id

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