Cartilage DamageSHARCNCT04889443
Spontaneous Healing of ARticular Cartilage (SHARC)
An observational study of Cartilage Damage and Cartilage Injury, run by Keele University at 1 site in United Kingdom.
Trial summary
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)… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cartilage Damage, Cartilage Injury
- What is being tested?
- Surgical cartilage repair procedure requiring harvest procedure or Autologous Stromal Cell Implantation
- Type of treatment
- Surgery or procedure
- How many people
- 15 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Sep 2018to 31 Dec 2023
- 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 undergoing surgery that involves the harvest of cartilage tissue as part of the treatment
Who may be able to join
- Being able to provide signed and dated informed consent form.
- Scheduled for one of the following surgical treatments
- Surgery that involves the harvest of cartilage tissue as part of the treatment, thus creating a fresh cartilage defect, which is then left to heal naturally. Examples of such surgery are autologous chondrocyte implantation (ACI) and mosaicplasty.
- Autologous stromal cell implantation (ASCI), as part of the ASCOT randomised clinical trial.
Who cannot join
- Inadequate understanding of verbal explanations or written information given in English, or having special communication needs.
- Chronic severe renal insufficiency
- Anything that would preclude the individual's full compliance with or completion of the study.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
RJAH Orthopaedic Hospital NHS Foundation Trust
Oswestry, Shropshire, SY10 7AG
About this study
Official title: How do Cartilage Injuries Heal Naturally? An Observational Study of Spontaneously Healing Cartilage Defects
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.
Read the detailed description
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.
- Conditions
- Cartilage Damage, Cartilage Injury
- Being tested
- Surgical cartilage repair procedure requiring harvest procedure or Autologous Stromal Cell Implantation
- Keywords
- Cartilage repair
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Surgical cartilage repair procedure requiring harvest procedure or Autologous Stromal Cell ImplantationProcedure or surgery
Also called Autologous Chondrocyte Implantation (ACI), Matrix Assisted Chondrocyte Implantation (MACI)
Any surgical cartilage repair procedure of the knee that requires a harvest biopsy of knee cartilage, which will leave a controlled small cartilage injury
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 1 year after tissue harvest
Secondary outcomes (10)
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.
Measured: 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.
Measured: 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
Measured: 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).
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 1 year after tissue harvest
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2021
- Study start1 Sep 2018
- Primary completion31 Dec 2023
- Study completion31 Dec 2023
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.
- 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Keele University
- Sponsor type
- University, hospital or other
- Collaborators
- Robert Jones and Agnes Hunt Orthopaedic and District NHS Trust
- Responsible party
- Sponsor
- Investigators
- Jan Herman Kuiper, PhD, Principal investigator, Keele University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04889443
- Sponsor's protocol ID
- RG-0238-17-ISTM
- Other IDs
- 18/NW/0291, 243678, MR/N02706X/1
- Acronym
- SHARC
- Status last verified
- Mar 2024
- First submitted
- 7 May 2021
- Last updated
- 13 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- How do Cartilage Injuries Heal Naturally? An Observational Study of Spontaneously Healing Cartilage Defects
- ClinicalTrials.gov ID
- NCT04889443
- Acronym / sponsor ID
- SHARC / RG-0238-17-ISTM
- Conditions
- Cartilage Damage, Cartilage Injury
- Keywords
- Cartilage repair
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Keele UniversityUniversity, hospital or other
- Collaborators
- Robert Jones and Agnes Hunt Orthopaedic and District NHS Trust
- Study start
- 1 Sep 2018 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 17 May 2021 (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.
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.
Detailed description
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.
Study design
- Observational model
- Case only
- 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 undergoing surgery that involves the harvest of cartilage tissue as part of the treatment
Key inclusion criteria (4 listed)
- Being able to provide signed and dated informed consent form.
- Scheduled for one of the following surgical treatments
Key exclusion criteria (3 listed)
- Inadequate understanding of verbal explanations or written information given in English, or having special communication needs.
- Chronic severe renal insufficiency
- Anything that would preclude the individual's full compliance with or completion of the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Surgical cartilage repair procedure requiring harvest procedure or Autologous Stromal Cell ImplantationAlso: Autologous Chondrocyte Implantation (ACI), Matrix Assisted Chondrocyte Implantation (MACI)Any surgical cartilage repair procedure of the knee that requires a harvest biopsy of knee cartilage, which will leave a controlled small cartilage injury | Procedure or surgery | – |
Primary outcome
Fraction of hyaline cartilage in harvest repair tissue
Time frame: 1 year after tissue harvest
Fraction of hyaline or mixed hyaline/fibrous cartilage in a 1-year biopsy assessed using OsScore cartilage histology criteria
10 secondary outcomes
Visual quality of the repair tissue in harvest repair tissue
Time frame: 1 year after tissue harvest
Quality of harvest repair tissue assessed from MRI images
Time frame: 1 year after tissue harvest
Mean signal intensity of harvest repair tissue on MRI
Time frame: 1 year after tissue harvest
Quality of harvest repair tissue assessed from a biopsy using the ICRS-II histology score
Time frame: 1 year after tissue harvest
Quality of harvest repair tissue assessed from a biopsy using the OsScore histology score
Time frame: 1 year after tissue harvest
Correlation of harvest repair tissue quality with baseline risk of osteoarthritis
Time frame: 1 year after tissue harvest
Correlation of harvest repair tissue quality with local mechanical load at the defect
Time frame: 1 year after tissue harvest
Match of biomarker level time course 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.
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.
Time frame: 1 year after tissue harvest
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2024.
- Individual participant dataSharing planned: 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.
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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.
Jan Herman Kuiper, PhD principal investigator
Keele University
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 Cartilage Injury, run by Keele University at 1 site in United Kingdom.
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 4 inclusion and 3 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: finished, as of the sponsor's last update on 13 Mar 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 United Kingdom. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fraction of hyaline cartilage in harvest repair tissue (time frame: 1 year after tissue harvest). 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 13 Mar 2024.