Validation of a new MRI method for assessing cartilage damage in the hip
Histological Validation of dGEMRIC Indices as a Quantitative Biomarker for Cartilage Damage in the Hip Joint
Insel Gruppe AG, University Hospital Bern · NCT06185036
This study is testing a new MRI method to see if it can accurately measure cartilage damage in people with severe hip osteoarthritis who are having hip replacement surgery.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 25 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Insel Gruppe AG, University Hospital Bern (other) |
| Locations | 1 site (Bern) |
| Trial ID | NCT06185036 on ClinicalTrials.gov |
What this trial studies
This observational study aims to validate the dGEMRIC (delayed gadolinium enhanced MRI of cartilage) technique as a quantitative biomarker for cartilage damage in patients with advanced hip osteoarthritis. By comparing 3D model-based dGEMRIC values to histologic grading of cartilage quality from femoral head samples collected during hip replacement surgery, the study seeks to improve preoperative assessments. The study will enroll 25 patients who are scheduled for total hip arthroplasty and will undergo specific imaging procedures to gather data on cartilage condition.
Who should consider this trial
Good fit: Ideal candidates for this study are patients with advanced hip osteoarthritis who are scheduled for hip replacement surgery.
Not a fit: Patients who have had previous hip surgeries or those with certain comorbidities may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the accuracy of preoperative assessments for patients with hip osteoarthritis, potentially leading to better treatment decisions.
How similar studies have performed: While the dGEMRIC technique is relatively novel, similar imaging approaches have shown promise in assessing cartilage health, suggesting potential for success in this validation effort.
Eligibility criteria
Show full inclusion / exclusion criteria
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).
Where this trial is running
Bern
- University Hospital of Bern (Inselspital) — Bern, Switzerland (RECRUITING)
Study contacts
- Principal investigator: Simon D. Steppacher, PD Dr. — University Hospital of Bern (Inselspital)
- Study coordinator: Jose A. Roshardt, Dr.
- Email: jose.roshardt@insel.ch
- Phone: +41316640440
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Cartilage Damage, Osteoarthritis, Hip, dGEMRIC, Biomarker