UnknownNot Applicable

Histological Validation of dGEMRIC Indices as a Quantitative Biomarker for Cartilage Damage in the Hip Joint

Switzerland25 participantsStarted 2022-09-01

Plain-language summary

In this study, the investigators seek to validate 3D model-based dGEMRIC (delayed gadolinium enhanced MRI of cartilage) values against histologic grading of cartilage quality, using osteochondral samples of the femoral head collected during hip replacement surgery.

Who can participate

Age range

18 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: * Patients with advanced hip osteoarthritis. * Preoperative hip MRI including biochemical sequence (MP2RAGE). * Indication for hip replacement. Exclusion Criteria: * Patients without informed consent. * Age under 18 years. * Insufficient language understanding in German, French, or English. * Previous hip surgeries. * Neoplastic and inflammatory comorbidities of the hip. * Post-traumatic or pediatric deformities. * Avascular necrosis of the femoral head. * Inadequate MRI image quality (motion artifacts, extra-articular contrast media administration, delay (\>45 minutes) between contrast injection and MRI imaging).

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

Correlation coefficient of dGEMRIC indices and histological cartilage quality

Timeframe: Within 12 months after histological analysis

Trial details

NCT IDNCT06185036

SponsorInsel Gruppe AG, University Hospital Bern

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2025-03-31

Contact for this trial

Jose A. Roshardt, Dr.

+41316640440 jose.roshardt@insel.ch

View on ClinicalTrials.gov More Cartilage Damage trials

Who can participate

Age range

18 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.