Cartilage DamageNCT06185036
Histological Validation of dGEMRIC Indices as a Quantitative Biomarker for Cartilage Damage in the Hip Joint
An observational study of Cartilage Damage and Osteoarthritis, Hip, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cartilage Damage, Osteoarthritis, Hip
- How many people
- 25 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Sep 2022to 31 Dec 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Patients with advanced hip osteoarthritis.
- Preoperative hip MRI including biochemical sequence (MP2RAGE).
- Indication for hip replacement.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
Switzerland1 site, 1 recruiting
- Recruiting
University Hospital of Bern (Inselspital)
Bern, 3010
Jose A. Roshardt, Dr., +41 31 664 04 40, jose.roshardt@insel.ch
About this study
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.
Read the detailed description
For patients with advanced hip joint degeneration visible on pelvic radiographs, joint-preserving surgery is often not an option, making joint replacement the primary treatment choice. However, for those with moderate signs of degeneration, the choice between joint-preserving surgery and replacement can be challenging. This decision often relies on imaging techniques such as preoperative direct MR arthrography.
Recent developments in medical imaging have led to new biochemical MRI sequences, such as dGEMRIC. These sequences are valuable for assessing the condition of cartilage before significant morphologic changes occur. By measuring glycosaminoglycan (GAG) content in cartilage, dGEMRIC provides early insight into cartilage degradation. Incorporating these sequences into standard MRI protocols allows the generation of dGEMRIC indices and the creation of 3D models of hip cartilage, improving the overall assessment of the hip joint.
The purpose of this study is to validate 3D model-based dGEMRIC values by comparing them to histologic assessments of cartilage degeneration. The hypothesis is that the dGEMRIC indices from the 3D MRI model will correlate with the histologic grading of cartilage quality in femoral cartilage samples obtained during hip replacement surgery.
This study aims to enroll 25 patients scheduled for total hip arthroplasty. Each participant will undergo preoperative biplanar hip radiographs and direct MR arthrography at 3 Tesla, including the dGEMRIC sequence, according the hospital's standard protocol.
Surgeries will performed by an experienced orthopaedic hip surgeon. The procedure will involve the femoral neck osteotomy, followed by the removal of the head-neck fragment, and the implantation of the hip prosthesis. Osteochondral samples will be taken from four areas of the femoral head. These will be analyzed using toluidine blue and safranin-O staining to assess cartilage damage.
A validated artificial intelligence algorithm will be used for 3D segmentation, visualization and calculation of morphological and biochemical parameters, which will be compared with histological results to determine a dGEMRIC threshold for identifying cartilage damage.
- Conditions
- Cartilage Damage, Osteoarthritis, Hip
- Keywords
- dGEMRIC, Biomarker
- Medical subject headings
- Osteoarthritis, Hip
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Within 12 months after histological analysis
Secondary outcomes (3)
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.
Measured: Within 12 months after MRI/patient enrollment
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).
Measured: 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)
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.
Measured: Within 1-2 weeks after sample acquisition
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2023
- Study start1 Sep 2022
- Primary completion31 Mar 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cartilage DamageStudies of the same condition, open and under way.
- More trials run by Insel Gruppe AG, University Hospital BernThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Insel Gruppe AG, University Hospital Bern
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Simon D. Steppacher, PD Dr., Principal investigator, University Hospital of Bern (Inselspital)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06185036
- Sponsor's protocol ID
- 2022-01313
- Other IDs
- 320030_205091
- Status last verified
- Jan 2024
- First submitted
- 14 Dec 2023
- Last updated
- 11 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Histological Validation of dGEMRIC Indices as a Quantitative Biomarker for Cartilage Damage in the Hip Joint
- ClinicalTrials.gov ID
- NCT06185036
- Acronym / sponsor ID
- 2022-01313
- Conditions
- Cartilage Damage, Osteoarthritis, Hip
- Keywords
- dGEMRIC, Biomarker
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Insel Gruppe AG, University Hospital BernUniversity, hospital or other
- Study start
- 1 Sep 2022 (actual)
- Primary completion
- 31 Mar 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 29 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
For patients with advanced hip joint degeneration visible on pelvic radiographs, joint-preserving surgery is often not an option, making joint replacement the primary treatment choice. However, for those with moderate signs of degeneration, the choice between joint-preserving surgery and replacement can be challenging. This decision often relies on imaging techniques such as preoperative direct MR arthrography.
Recent developments in medical imaging have led to new biochemical MRI sequences, such as dGEMRIC. These sequences are valuable for assessing the condition of cartilage before significant morphologic changes occur. By measuring glycosaminoglycan (GAG) content in cartilage, dGEMRIC provides early insight into cartilage degradation. Incorporating these sequences into standard MRI protocols allows the generation of dGEMRIC indices and the creation of 3D models of hip cartilage, improving the overall assessment of the hip joint.
The purpose of this study is to validate 3D model-based dGEMRIC values by comparing them to histologic assessments of cartilage degeneration. The hypothesis is that the dGEMRIC indices from the 3D MRI model will correlate with the histologic grading of cartilage quality in femoral cartilage samples obtained during hip replacement surgery.
This study aims to enroll 25 patients scheduled for total hip arthroplasty. Each participant will undergo preoperative biplanar hip radiographs and direct MR arthrography at 3 Tesla, including the dGEMRIC sequence, according the hospital's standard protocol.
Surgeries will performed by an experienced orthopaedic hip surgeon. The procedure will involve the femoral neck osteotomy, followed by the removal of the head-neck fragment, and the implantation of the hip prosthesis. Osteochondral samples will be taken from four areas of the femoral head. These will be analyzed using toluidine blue and safranin-O staining to assess cartilage damage.
A validated artificial intelligence algorithm will be used for 3D segmentation, visualization and calculation of morphological and biochemical parameters, which will be compared with histological results to determine a dGEMRIC threshold for identifying cartilage damage.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- Patients with advanced hip osteoarthritis.
- Preoperative hip MRI including biochemical sequence (MP2RAGE).
- Indication for hip replacement.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Correlation coefficient of dGEMRIC indices and histological cartilage quality
Time frame: Within 12 months after histological analysis
Linear regression analysis will be performed to assess the correlation between dGEMRIC scores and the histological evaluation of cartilage quality.
3 secondary outcomes
dGEMRIC indices from 3D MRI cartilage model (T1 relaxation time in milliseconds)
Time frame: Within 12 months after MRI/patient enrollment
Intensity of Toluidine blue staining as a histological value of cartilage damage (Mankin grading 0-14)
Time frame: 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)
Time frame: Within 1-2 weeks after sample acquisition
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Simon D. Steppacher, PD Dr. principal investigator
University Hospital of Bern (Inselspital)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cartilage Damage and Osteoarthritis, Hip, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jose A. Roshardt, Dr. (+41316640440, jose.roshardt@insel.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation coefficient of dGEMRIC indices and histological cartilage quality (time frame: Within 12 months after histological analysis). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jan 2024.