CompletedNot Applicable

Effects of Osteotomies Around the Knee on Cartilage Glycosaminoglycan Content Using dGEMRIC Non-invasive Imaging

Netherlands10 participantsStarted 2007-07

Plain-language summary

Medial compartment osteoarthritis of the knee is commonly treated by a surgical intervention called 'high tibial osteotomy' (VTO). Although it has repeatedly been shown that pain improves following this procedure, it is unknown how cartilage quality is affected by the procedure. In this study, a recently developed MRI technique is used to evaluate changes in cartilage quality before and after the surgery. Changes in MRI signals are correlated to subjective improvements (score lists). 10 patients participate in this study. Approval has been granted by the Medical Ethical Committee of the University Medical Center Utrecht. All participants are required to give informed consent before participation.

Who can participate

Age range

18 Years – 85 Years

Sex

ALL

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

Inclusion Criteria: Ten patients will be included satisfying the following inclusion criteria: * Both males and females * Patients \>18 years old * Indication as set by treating physician for operative procedure around the knee: HTO (high tibial osteotomy), femoral osteotomy * Patient informed consent signed Note: Patients with previous surgery, history of intra-articular medication, meniscectomy or ACL lesions can be included in this study. Exclusion Criteria: * The following patients are excluded from participating in this study: * Known anaphylactic reactions to Gadolinium or related substances * Kidney diseases with a creatinin excretion of \< 20 ml/min * Risk groups for MRI scanning due to magnetic field or contrast agent (9, 10): Metal in body: Pacemaker / AICD / ICD (coronary defibrillator), Nervus vagus (X) stimulator, Artificial heart valve (depending on type), Metal clips on cerebral arteries or veins, Metal particles in eye, Port-a-cath, Metal stents, Hydrocephalic pump / insuline pump, Metal implants; f/e screws, prostheses, piercings. * Claustrofibia * First three months of pregnancy (not sufficient information available about effects of contrast agent on foetal development in this stage). Patients will be asked if they may be pregnant (\< 3 months of pregnancy): if uncertain, they will be excluded. Contra-indications for MRI scanning, as well as contra-indications to intra-venous administration of contrast agents were discussed with Ms. Shanta Kalaykhan-Sew…

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

MRI T1 signal, change from baseline

Timeframe: Change from baseline 9 months after surgery (HTO)

Trial details

NCT IDNCT01269944

SponsorUMC Utrecht

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2011-02

View on ClinicalTrials.gov More Medial Compartment Osteoarthritis of the Knee trials