Knee OsteoarthritisUNIKORNNCT05442242
Unicompartmental Knee Arthroplasty vs. High Tibial Osteotomy for Medial Knee Osteoarthritis (UNIKORN): a Study Protocol of a Randomized Controlled Trial
A study testing Unicompartmental knee arthroplasty and High tibial osteotomy in people with Knee Osteoarthritis, run by Töölö Hospital.
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. Read more about this study
- Who is it for?
- Ages 45 to 65 years
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- Unicompartmental knee arthroplasty and High tibial osteotomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- Nov 2022to Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Isolated KL 3-4 medial knee arthrosis
- Varus > 3 degrees
- Age 45-65 years
Who cannot join
- Post-traumatic arthrosis
- Arthrosis in the lateral compartment more than KL grade I in MRI
- Post- traumatic arthrosis
- Instability
- Malignancy Obesity
Trial locations and contacts
No sites are listed yet.
About this study
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.
- Conditions
- Knee Osteoarthritis
- Being tested
- Unicompartmental knee arthroplasty, High tibial osteotomy
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Unicompartmental knee arthroplastyProcedure or surgery
Medial Unicompartmental knee arthroplasty
High tibial osteotomyProcedure or surgery
Medial open wedge high tibial osteotomy
| Study group | Role | What they receive |
|---|---|---|
| Unicompartmental knee osteoarthritis | Active comparator | Not described Receives: Procedure: Unicompartmental knee arthroplasty |
| High tibial osteotomy | Active comparator | Not described Receives: Procedure: High tibial osteotomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
KOOS
Measured: 1- year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2022
- Study startNov 2022 (estimated)
- Primary completionDec 2024 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Knee OsteoarthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Töölö Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Juuso Siren, Töölö Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05442242
- Sponsor's protocol ID
- HUS/1259/2019
- Acronym
- UNIKORN
- Status last verified
- Jul 2022
- First submitted
- 28 Jun 2022
- Last updated
- 6 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 37016454
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Unicompartmental Knee Arthroplasty vs. High Tibial Osteotomy for Medial Knee Osteoarthritis (UNIKORN): a Study Protocol of a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05442242
- Acronym / sponsor ID
- UNIKORN / HUS/1259/2019
- Conditions
- Knee Osteoarthritis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Töölö HospitalUniversity, hospital or other
- Study start
- Nov 2022 (estimated)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 1 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Unicompartmental knee osteoarthritis | Active comparator | Procedure: Unicompartmental knee arthroplasty |
| High tibial osteotomy | Active comparator | Procedure: High tibial osteotomy |
Who may qualify
- Ages
- 45 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Isolated KL 3-4 medial knee arthrosis
- Varus > 3 degrees
- Age 45-65 years
Key exclusion criteria (5 listed)
- Post-traumatic arthrosis
- Arthrosis in the lateral compartment more than KL grade I in MRI
- Post- traumatic arthrosis
- Instability
- Malignancy Obesity
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Unicompartmental knee arthroplastyMedial Unicompartmental knee arthroplasty | Procedure or surgery | Unicompartmental knee osteoarthritis |
| High tibial osteotomyMedial open wedge high tibial osteotomy | Procedure or surgery | High tibial osteotomy |
Primary outcome
KOOS
Time frame: 1- year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2022.
- Derived from this study: PubMed 37016454Siren 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A study testing Unicompartmental knee arthroplasty and High tibial osteotomy in people with Knee Osteoarthritis, run by Töölö Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Juuso Siren, MD (0407005858, juuso.siren@hus.fi), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
KOOS (time frame: 1- year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05442242, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jul 2022.