RecruitingNot Applicable

Ligament Balancing in Total Knee Arthroplasty

Norway40 participantsStarted 2024-05-01

Plain-language summary

The goal of this interventional pilot study is to evaluate if performing ligament balancing on the medial collateral ligament (MCL) in a more systematical manner with a novel instrument can produce more objective and repeatable ligament lengthening in Total Knee Arthroplasty. The main questions it aim to answer are: 1. Is it feasible to perform systematic ligament balancing on the MCL using a novel instrument? 2. Can a novel instrument for ligament balancing acquire more objective and repeatable results, without risk of injury? Participants must consent prior to the surgery, but inclusion is only done once ligament balancing is indicated during surgery. Patients will be follow-up as standard protocol for Total Knee Arthroplasty patients at the hospital.

Who can participate

Age range

40 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: * Men and women over 40 years of age that require total knee arthroplasty * Idiopathic osteoarthrosis, osteonecrosis or avascular osteonecrosis * Otherwise fairly healthy/ no significant health issues Exclusion Criteria: * Age under 40 years of age * Pregnant * Revisions or reoperations * Considerable earlier injury to the knee * Isolated patellofemoral osteoarthrosis

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

Is it feasible to perform systematic ligament balancing on the MCL using a novel instrument?

Timeframe: 1 year

MCL-lengthening in millimeters after ligament balancing using the novel instrument

Timeframe: 1 year

Trial details

NCT IDNCT06264076

SponsorOslo University Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-12-31

Contact for this trial

Lars HW Engseth, MD

004741254136 laengs@ous-hf.no

View on ClinicalTrials.gov More Ligament; Laxity, Knee trials