CompletedNot Applicable

Impact of High Tibial Osteotomy in Preventing Degenerative Disease Progression in Medial Knee Osteoarthritis.

Italy50 participantsStarted 2021-05-17

Plain-language summary

High tibial osteotomy (HTO) surgical procedure can lead to clinically significant improvements in the cartilage and in subchondral bone quality, with a slow down of the osteoarthritis (OA) progression. Aim of the project is to: (i) clinically validate a 3D planned HTO surgical approach, through a quantitative grading of OA progression in a prospective randomized case-control clinical trial; (ii) correlate the internal knee loads with the changes assessed in cartilage and subchondral bone status to verify the hypothesis that HTO induced mechanical changes are associated with clinically significant OA improvements; (iii) relate imaging data with cartilage and subchondral bone mechanical properties, in order to classify OA progression in a more sensitive manner and allow a more precise diagnosis of the pathology stage.

Who can participate

Age range

40 Years – 65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * medial knee osteoarthritis in varus knee malalignment (\> 4°) Exclusion Criteria: * Inability to sign informed consent * joint infection * inflammatory chronic disease * previous major surgical procedure of the indexed knee (simple arthroscopy or meniscectomy would be not considered major procedure) * BMI \> 30

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Cartilage morphology and composition assessment via T1rho and T2 mapping from 3Tesla (3T) magnetic resonance imaging(MRI).

Timeframe: 3 years

Subchondral bone morphological and structural analysis via Cone Bean Computed Tomography (CBCT) of the knee.

Timeframe: 3 years

Clinical Score for Knee function 1

Timeframe: 3 years

Clinical Score for Knee function 2

Timeframe: 3 years

Clinical Score for Knee function 3

Timeframe: 3 years

Trial details

NCT IDNCT05865899

SponsorIstituto Ortopedico Rizzoli

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-03-22

View on ClinicalTrials.gov More Knee Osteoarthritis trials

Plain-language summary

Who can participate

Age range

40 Years – 65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Cartilage morphology and composition assessment via T1rho and T2 mapping from 3Tesla (3T) magnetic resonance imaging(MRI).

Timeframe: 3 years

Subchondral bone morphological and structural analysis via Cone Bean Computed Tomography (CBCT) of the knee.

Timeframe: 3 years

Clinical Score for Knee function 1

Timeframe: 3 years

Clinical Score for Knee function 2

Timeframe: 3 years

Clinical Score for Knee function 3

Timeframe: 3 years