UnknownNot Applicable

High Tibial Osteotomy With/Without Fulkerson Osteotomy in Knee OA

Poland110 participantsStarted 2020-07-15

Plain-language summary

This study will compare Hight Tibial Osteotomy with or without Fulkerson Osteotomy performed on patients with early stages of Osteoarthritis with patellofemoral joint disorders. The purpose of this study is evaluate which type of osteotomy provides better clinical, radiological and laboratory outcomes.

Who can participate

Age range

18 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: * Knee medial compartment or patellofemoral osteoarthritis in medical interview and physical examination * Confirmation of cartilage degeneration/damage and knee malalignment in radiological tests Exclusion Criteria: * no informed consent to participate in the study * age under 18 years or above 65 * multi ligament injury or single plane knee instability * another musculoskeletal disorders in lower limb * lower limb deformity requiring axis correction below 4o or above 12.5o * joints inflammatory diseases * ASA score \> II

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

Biomechanics MRI

Timeframe: 1 year

Biomechanics MRI

Timeframe: 2 years

Biomechanics X-ray

Timeframe: 12 weeks

Biomechanics X-ray

Timeframe: 6 months

Biomechanics X-ray

Timeframe: 12 months

Biomechanics X-ray

Timeframe: 24 months

Trial details

NCT IDNCT05128864

SponsorCentre of Postgraduate Medical Education

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-05-30

Contact for this trial

Rafał Kamiński, MD PhD

+48227794031 kaminski@spskgruca.pl

View on ClinicalTrials.gov More Osteoarthritis, Knee trials

Plain-language summary

Who can participate

Age range

18 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.