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

NCT06185036 | Unknown

• 2 other identifiers: 2022-01313320030_205091
• Study Type: observational
• Target: 25
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Cartilage Damage; Osteoarthritis, Hip

Keywords

dGEMRIC; Biomarker

Outcome Measures

Primary Outcomes (1)

• Correlation coefficient of dGEMRIC indices and histological cartilage quality

  Linear regression analysis will be performed to assess the correlation between dGEMRIC scores and the histological evaluation of cartilage quality.

  Within 12 months after histological analysis

Secondary Outcomes (3)

• dGEMRIC indices from 3D MRI cartilage model (T1 relaxation time in milliseconds)

  Within 12 months after MRI/patient enrollment

• Intensity of Toluidine blue staining as a histological value of cartilage damage (Mankin grading 0-14)

  Within 1-2 weeks after sample acquisition

• Intensity of Safranin-O staining as a histological value of cartilage damage (Relative red fraction of the RGB scale, 0-255)

  Within 1-2 weeks after sample acquisition

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients in the outpatient clinic who meet the inclusion criteria will be informed about the study during orthopaedic consultations. Screening is not required as all necessary information is available from standard diagnostics. Patients will be provided with study and surgical consent forms to be signed after an informed consent interview with one of the investigators. There is no financial compensation for participation in the study.

You may qualify if:

• Patients with advanced hip osteoarthritis.
• Preoperative hip MRI including biochemical sequence (MP2RAGE).
• Indication for hip replacement.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Insel Gruppe AG, University Hospital Bern: lead

Study Sites (1)

University Hospital of Bern (Inselspital)

Bern, 3010, Switzerland

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Fixed osteochondral samples

MeSH Terms

Conditions

Osteoarthritis, Hip

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Simon D. Steppacher, PD Dr.

  University Hospital of Bern (Inselspital)

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jose A. Roshardt, Dr.

CONTACT

+41316640440; jose.roshardt@insel.ch

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 14, 2023
• First Posted: December 29, 2023
• Study Start: September 1, 2022
• Primary Completion: March 31, 2025
• Study Completion: December 31, 2025
• Last Updated: January 11, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)