An observational study in Cartilage Damage and Cartilage Injury, sponsored by Keele University. Completed at 1 site in United Kingdom. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-03-13.
Sponsored by Keele University · Observational
SHARC is an observational study of cartilage patients who are treated with surgery that involves obtaining a harvest biopsy. SHARC will study the natural healing process of the harvest biopsy site based on histological and biochemical analyses of repair tissue biopsies, synovial fluid biomarkers, medical imaging (MRI) and gait analysis.
Osteoarthritis (OA) is a very common disease of the joints, for which in the United Kingdom alone almost 9 million people have sought treatment. This painful disease affects the cartilage and bone inside the joint. Many factors are known to increase the risk of getting osteoarthritis, or the rate at which it gets worse. Very important among these factors is an injury or a defect of the cartilage. It was believed for hundreds of years that cartilage, once injured, does not heal.
Research from the past 10 years is now throwing doubt on this old certainty, as researchers who took regular scans of volunteers over time noted that sometimes these defects come and then go. A Japanese group of surgeons decided to look again after a year to see what had happened to these defects, and noted that about half of them had got better! Cartilage defects in human therefore can heal, but nobody knows how this works.
For many years, our Center has helped patients who have knee cartilage damage by using the patients' own cartilage cells to help repair areas of damaged cartilage. This cell therapy starts by taking a piece of cartilage (10 mm) from the patient's knee, and this created defect always heals after a year. Thus, our proposal is to use our cell therapy patients as a human experimental model of natural cartilage healing using a wide range of techniques including Magnetic Resonance Imaging (MRI), visual inspection of the joint itself during knee joint surgery, examining biopsies of repair tissue down the microscope and measuring various kinds of molecules researchers think are important. The information gathered from these tests will help bridge the gap in our understanding of the mechanisms involved in the cartilage tissue regeneration.
Keele University is the lead sponsor of 16 studies on the registry; 4 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients undergoing surgery that involves the harvest of cartilage tissue as part of the treatment
Scheduled for one of the following surgical treatments
Exclusion Criteria:
Any surgical cartilage repair procedure of the knee that requires a harvest biopsy of knee cartilage, which will leave a controlled small cartilage injury
Also known as: Autologous Chondrocyte Implantation (ACI), Matrix Assisted Chondrocyte Implantation (MACI)
Fraction of hyaline cartilage in harvest repair tissue
Fraction of hyaline or mixed hyaline/fibrous cartilage in a 1-year biopsy assessed using OsScore cartilage histology criteria
Time frame: 1 year after tissue harvest
Visual quality of the repair tissue in harvest repair tissue
Visual quality of the repair tissue in a tissue biopsy obtained at 1 year, assessed using the corresponding item in the International Cartilage Repair Society (ICRS)-II arthroscopy score.
Time frame: 1 year after tissue harvest
Quality of harvest repair tissue assessed from MRI images
The quality of the repair tissue assessed from MRI images using the Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) score obtained at 1 year.
Time frame: 1 year after tissue harvest
Mean signal intensity of harvest repair tissue on MRI
The mean signal intensity of the repair tissue on an MRI T2 map obtained at 1 year
Time frame: 1 year after tissue harvest
Quality of harvest repair tissue assessed from a biopsy using the ICRS-II histology score
Quality of repair tissue assessed from a tissue biopsy at 1 year by the total ICRS-II histology score (ordinal scale from 0 to 140).
Time frame: 1 year after tissue harvest
Quality of harvest repair tissue assessed from a biopsy using the OsScore histology score
Quality of repair tissue assessed from a tissue biopsy at 1 year by the OsScore histology score (ordinal scale from 0 to 10).
Time frame: 1 year after tissue harvest
Correlation of harvest repair tissue quality with baseline risk of osteoarthritis
Correlation of total ICRS-II histology score of a repair tissue biopsy versus the baseline risk of osteoarthritis assessed using the minimal Rotterdam prediction model.
Time frame: 1 year after tissue harvest
Correlation of harvest repair tissue quality with local mechanical load at the defect
Correlation of quality of repair tissue (outcome 3) versus local mechanical load at the defect as assessed using gait analysis at baseline and 1 year.
Time frame: 1 year after tissue harvest
Match of biomarker level time course to a postulated pattern of cartilage repair, namely Inflammation-Repair-Remodelling.
Match of the time course of biomarker levels measured at baseline, 3 month and 1 year to a postulated pattern of cartilage repair, namely Inflammation-Repair-Remodelling.
Time frame: 1 year after tissue harvest
Correlation between levels of inflammatory biomarkers and inflammatory activity measured on dynamic contrast-enhanced magnetic resonance imaging (DCE-MRI) at baseline and 1 year.
Correlation between levels of inflammatory biomarkers and inflammatory activity measured on dynamic contrast-enhanced magnetic resonance imaging (DCE-MRI) at baseline and 1 year. DCE-MRI is a non-invasive imaging technique used to determine the state of inflammation in tissue and is routinely used to assess inflammation in patients with rheumatoid arthritis. The level of inflammation will be assessed as the percentage increase in signal intensity per second from the onset of signal increase until the maximum signal.
Time frame: 1 year after tissue harvest
Correlation of level of levels of inflammatory activity determined in a repair tissue biopsy versus that measured on DCE-MRI.
Correlation between grade of inflammatory biomarkers in a repair tissue biopsy at 1 year as analysed using immunohistochemistry (IHC) and level of inflammatory activity as measured on DCE-MRI. The grade of inflammation on IHC will be assessed as the mean staining intensity per cell, and the level of inflammatory activity on DCE-MRI will be assessed as described for Outcome 10, but using a region of interest encompassing only the location of the biopsy.
Time frame: 1 year after tissue harvest
Plan to share: Yes — After the study end and publication of results, individual data will be available upon request to the PI. No patient identifiable information will be shared. All individual data will be link-anonymized and a minimum of 3-way anonymization of relevant data will be used to ensure that participants cannot be identified from the supplied data.
Supporting information: Study protocol
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This study is completed, as verified in Mar 2024. You cannot join it, but the record below documents what was studied.
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Keele University