Osteoarthritis, Hip Clinical Trial
Official title:
Histological Validation of dGEMRIC Indices as a Quantitative Biomarker for Cartilage Damage in the Hip Joint
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.
Status | Recruiting |
Enrollment | 25 |
Est. completion date | December 31, 2025 |
Est. primary completion date | March 31, 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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). |
Country | Name | City | State |
---|---|---|---|
Switzerland | University Hospital of Bern (Inselspital) | Bern |
Lead Sponsor | Collaborator |
---|---|
Insel Gruppe AG, University Hospital Bern |
Switzerland,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | dGEMRIC indices from 3D MRI cartilage model (T1 relaxation time in milliseconds) | A validated artificial intelligence based algorithm will be used for automated segmentation and visualization of 3D cartilage models and calculation of dGMERIC values. These dGEMRIC values are displayed topographically and color-coded in the 3D model. This allows visual and three-dimensional assessment of cartilage quality. | Within 12 months after MRI/patient enrollment | |
Secondary | Intensity of Toluidine blue staining as a histological value of cartilage damage (Mankin grading 0-14) | One of the two osteochondral samples from each of the four regions of the femoral head will be fixed for toluidine blue staining to determine the Mankin score. This staining method is used to grade cartilage damage. An experienced histopathologist will evaluate these sections, performing the Mankin grading, which ranges from 0 (indicating no histologic cartilage damage) to 14 (signifying end-stage cartilage damage). | Within 1-2 weeks after sample acquisition | |
Secondary | Intensity of Safranin-O staining as a histological value of cartilage damage (Relative red fraction of the RGB scale, 0-255) | The other osteochondral sample from each region will be used for the Safranin-O staining. An image analysis software (ImageJ, National Institute of Health, Bethesda Md) will be used to quantify the intensity of the Safranin-O staining. This quantification is represented by the relative amount of red in RGB analysis, with intensity values ranging from 0 to 255. This analysis will be performed without reference to the MRI images to ensure objectivity. | Within 1-2 weeks after sample acquisition |
Status | Clinical Trial | Phase | |
---|---|---|---|
Active, not recruiting |
NCT05773261 -
Clinical Investigation Comparing Two Different Ultra-porous Coated Surfaces of Uncemented Cups
|
N/A | |
Recruiting |
NCT05223777 -
KINCISEā¢ Surgical Automated System in Total Hip Arthroplasty (THA)
|
N/A | |
Recruiting |
NCT04731077 -
Avenir Complete Post-Market Clinical Follow-Up Study
|
N/A | |
Not yet recruiting |
NCT04448106 -
Autologous Adipose Tissue-Derived Mesenchymal Stem Cells (AdMSCs) for Osteoarthritis
|
Phase 2 | |
Completed |
NCT05070871 -
A Clinical Trial Investigating the Effect of Salmon Bone Meal on Osteoarthritis Among Men and Women
|
N/A | |
Not yet recruiting |
NCT06162195 -
The ACTIVE Trial: A Prospective Randomised Control Trial Of The H1 Implant Versus Total Hip Replacement
|
N/A | |
Withdrawn |
NCT02743208 -
Evaluation of a Short Femoral Stem in Total Hip Arthroplasty
|
N/A | |
Completed |
NCT02944448 -
A Study Evaluating Pain Relief and Safety of Orally Administered CR845 in Patients With Osteoarthritis of Hip or Knee
|
Phase 2 | |
Active, not recruiting |
NCT02229279 -
Evaluation of Teleconsulting on Rehabilitation After Hip and Knee Surgical Procedures
|
N/A | |
Active, not recruiting |
NCT02851992 -
A Prospective Study to Evaluate Long-term Clinical Outcomes of the GTS Cementless Femoral Stem
|
N/A | |
Completed |
NCT01700933 -
Dose-response: Exercise Therapy on Hip Osteoarthritis
|
N/A | |
Completed |
NCT01618708 -
A Study of the Safety and Effectiveness of Synvisc-One® (Hylan G-F 20) in Patients With Primary Osteoarthritis of the Hip
|
N/A | |
Completed |
NCT01214954 -
Early Rehabilitation After Total Hip Replacement
|
N/A | |
Active, not recruiting |
NCT00294424 -
Study on Costs and Effects of Waiting Time in Total Hip and Knee Replacements
|
N/A | |
Terminated |
NCT00588861 -
Total Hip Replacement With the Answer® Hip Stem and Ranawat/Burnstein® Shell Using Simplex® or Palacos® Bone Cement
|
N/A | |
Withdrawn |
NCT05054595 -
Audio-Recorded vs. Nurse-Led Brief Mindfulness-Based Intervention
|
N/A | |
Terminated |
NCT00973141 -
A Dose-ranging Study of the Safety and Effectiveness of JNJ-42160443 as add-on Treatment in Patients With Osteoarthritis-related Pain
|
Phase 2 | |
Recruiting |
NCT05014113 -
H-28 DELTA ST-C and Minima Retrospective Study.
|
||
Completed |
NCT01066936 -
Mini Stem DEXA (Dual Energy X-ray Absorptiometry)
|
||
Recruiting |
NCT05530551 -
Effect of Single vs Multiple Prophylactic Antibiotic Doses on PJI Following Primary THA in Patients With OA
|
N/A |