Defect of Articular CartilageAURANCT02696876
Synovium Brushing to Augmented Microfracture for Improved Cartilage Repair
A study testing Arthroscopic synovial brushing and Microfracture in people with Defect of Articular Cartilage and Cartilage Injury, run by University of Leeds at 1 site in United Kingdom.
Trial summary
This is a proof-of-concept study to determine the safety and efficacy of a novel device to increase the reparative capacity of the knee. The discovery of a resident population of mesenchymal stem cells (MSCs) within synovial fluid (SF) was the first description of this reparative cell population having direct access… Read more about this study
- Who is it for?
- Ages 16 to 55 years
- Conditions the study is for
- Defect of Articular Cartilage, Cartilage Injury, Osteoarthritis, Knee
- What is being tested?
- Arthroscopic synovial brushing and Microfracture
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jan 2017to Oct 2023
- Phase
- Interventional
- 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 16 to 55 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Isolated cartilage defects (<2cm2)
- Patients undergoing microfracture for repair of cartilage defects
Who cannot join
- Septic arthritis
- Infectious disease
- Revision joint surgery
- Meniscal damage requiring repair
- Ligament damage requiring repair
- Cartilage defect greater than 2cm2
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- Contra-indications for MRI:
- Pacemakers, Implantable Cardioverter defibrillators, implantable cardiac loop recorders
- Surgical clips within the head
- Certain inner ear implants
- Neuro-electrical stimulators
- Metal fragments within the eye or head
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Chapel Allerton Orthopaedic Centre, Leeds Teaching Hospitals NHS Trust
Leeds, West Yorkshire, LS7 4SA
About this study
Official title: Safety and Efficacy of a Novel Synovium Brushing Method for Endogenous Mesenchymal Stem Cells Mobilisation During Knee Joint Microfracture for Cartilage Repair.
This is a proof-of-concept study to determine the safety and efficacy of a novel device to increase the reparative capacity of the knee. The discovery of a resident population of mesenchymal stem cells (MSCs) within synovial fluid (SF) was the first description of this reparative cell population having direct access to superficial cartilage and joint structures. The ready access of SF MSC to cartilage and other joint tissues offers a novel strategy for joint repair. Current arthroscopic procedures result in the removal of all SF MSCs due to continuous irrigation throughout the procedure. The current study would benefit the patient by greatly increasing the reparative capacity of the joint by bolstering MSC numbers and retaining those MSCs within the joint after surgery. By accessing MSCs from the synovium it is anticipated that these cells would be entrapped/migrate into the marrow clot formed by microfracture of the sub-chondral bone. These MSCs would supplement those from the marrow and may result in faster, better quality repair.
Read the detailed description
The synovium is a rich source of potent chondrogenic mesenchymal stromal cells (MSCs). Gaining access to this valuable source of regenerative cells could improve the outcome of joint restorative procedures. To avoid costly two-stage procedures and ex vivo manipulation, exploiting these autologous cells in a minimally invasive way with minimal manipulation could provide a novel cost-effective approach.
This study will evaluate the safety, feasibility and efficacy of a novel medical device (a synovial brush) and procedure (synovial brushing) to increase the number of autologous minimally manipulated MSCs in the knee. Twenty patients undergoing microfracture for isolated chondral defects will be randomly assigned to either a control group (microfracture only, 10 patients) or the intervention group (microfracture plus synovial brushing, 10 patients). The device is intended to increase the number of MSCs within the joint as a final stage during surgery, aiding repair by bolstering those MSCs recruited from the bone marrow.
- Being tested
- Arthroscopic synovial brushing, Microfracture
- Keywords
- Cartilage, Mesenchymal stromal cell, Microfracture, Knee, Defect, Injury, Stem cell, Autologous, Minimally manipulated
- Medical subject headings
- Osteoarthritis, Knee, Fractures, Stress, Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Arthroscopic synovial brushingDevice
The specific and novel surgical procedure that will be carried out here is synovial membrane brushing using a novel device that has been shown to release MSCs from the synovium in vitro. This technique will be carried out in the setting of therapeutic microfracture for cartilage defects.
MicrofractureProcedure or surgery
Also called Marrow-stimulation
Microfracture or marrow-stimulation is a surgical procedure to repair small isolated cartilage defects by recruiting bone marrow mesenchymal stromal cells by creating small holes ('micro fractures') in the sub-chondral bone. These cells are entrapped in the ensuing blood clot and contribute to partial repair of the cartilage.
| Study group | Role | What they receive |
|---|---|---|
| Control group | Active comparator | Patients in this group will received conventional microfracture treatment as indicated for isolated cartilage defects and defined by the inclusion criteria. Receives: Procedure: Microfracture |
| Intervention group | Experimental | Patients in this group will also receive microfracture for the treatment of isolated cartilage defects in combination with arthroscopic synovial brushing to access and release synovial MSCs into the joint space. Receives: Device: Arthroscopic synovial brushing |
What is being measured
The primary outcome is the main question the study is designed to answer.
The mean change in the number of MSCs present in the knee pre- and post- microfracture/microfracture plus arthroscopic synovial brushing.
Measured: 2 weeds
Secondary outcomes (5)
Number of patients whose clinical effusion scores improve at 3, 6 and 12 months
Measured: 3, 6 and 12 months
Number of patients whose semi-quantitative MRI cartilage scores improve at 6 and 12 months
Measured: up to 12 months
Median KOOS scores at 3, 6 and 12 months (pain; other symptoms; function in daily living; function in sport; knee-related QoL; average score)
Measured: 3, 6 and 12 months
Western Ontario and McMaster Universities Arthritis Index (WOMAC)
Median WOMAC scores at 3, 6 and 12 months (total; pain; stiffness; function)
Measured: 3, 6 and 12 months
Visual Analogue Scale (VAS)
Measured: 3, 6 and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2016 (estimated)
- Study startJan 2017
- Primary completionJan 2023
- Study completionOct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Defect of Articular CartilageStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Leeds
- Sponsor type
- University, hospital or other
- Collaborators
- The Leeds Teaching Hospitals NHS Trust
- Responsible party
- Principal investigator, Dennis McGonagle, University of Leeds
- Investigators
- Dennis G McGonagle, MB BcH BAO, Principal investigator, University of Leeds
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02696876
- Sponsor's protocol ID
- RR15/173
- Acronym
- AURA
- Status last verified
- Nov 2023
- First submitted
- 26 Feb 2016
- Last updated
- 29 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of a Novel Synovium Brushing Method for Endogenous Mesenchymal Stem Cells Mobilisation During Knee Joint Microfracture for Cartilage Repair.
- ClinicalTrials.gov ID
- NCT02696876
- Acronym / sponsor ID
- AURA / RR15/173
- Keywords
- Cartilage, Mesenchymal stromal cell, Microfracture, Knee, Defect, Injury, Stem cell, Autologous
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 4 participants (actual)
- Lead sponsor
- University of LeedsUniversity, hospital or other
- Collaborators
- The Leeds Teaching Hospitals NHS Trust
- Study start
- Jan 2017
- Primary completion
- Jan 2023 (actual)
- Study completion
- Oct 2023 (actual)
- First posted
- 2 Mar 2016 (estimated)
- 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.
This is a proof-of-concept study to determine the safety and efficacy of a novel device to increase the reparative capacity of the knee. The discovery of a resident population of mesenchymal stem cells (MSCs) within synovial fluid (SF) was the first description of this reparative cell population having direct access to superficial cartilage and joint structures. The ready access of SF MSC to cartilage and other joint tissues offers a novel strategy for joint repair. Current arthroscopic procedures result in the removal of all SF MSCs due to continuous irrigation throughout the procedure. The current study would benefit the patient by greatly increasing the reparative capacity of the joint by bolstering MSC numbers and retaining those MSCs within the joint after surgery. By accessing MSCs from the synovium it is anticipated that these cells would be entrapped/migrate into the marrow clot formed by microfracture of the sub-chondral bone. These MSCs would supplement those from the marrow and may result in faster, better quality repair.
Detailed description
The synovium is a rich source of potent chondrogenic mesenchymal stromal cells (MSCs). Gaining access to this valuable source of regenerative cells could improve the outcome of joint restorative procedures. To avoid costly two-stage procedures and ex vivo manipulation, exploiting these autologous cells in a minimally invasive way with minimal manipulation could provide a novel cost-effective approach.
This study will evaluate the safety, feasibility and efficacy of a novel medical device (a synovial brush) and procedure (synovial brushing) to increase the number of autologous minimally manipulated MSCs in the knee. Twenty patients undergoing microfracture for isolated chondral defects will be randomly assigned to either a control group (microfracture only, 10 patients) or the intervention group (microfracture plus synovial brushing, 10 patients). The device is intended to increase the number of MSCs within the joint as a final stage during surgery, aiding repair by bolstering those MSCs recruited from the bone marrow.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | Active comparator | Procedure: MicrofracturePatients in this group will received conventional microfracture treatment as indicated for isolated cartilage defects and defined by the inclusion criteria. |
| Intervention group | Experimental | Device: Arthroscopic synovial brushingPatients in this group will also receive microfracture for the treatment of isolated cartilage defects in combination with arthroscopic synovial brushing to access and release synovial MSCs into the joint space. |
Who may qualify
- Ages
- 16 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Isolated cartilage defects (<2cm2)
- Patients undergoing microfracture for repair of cartilage defects
Key exclusion criteria (12 listed)
- Septic arthritis
- Infectious disease
- Revision joint surgery
- Meniscal damage requiring repair
- Ligament damage requiring repair
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 |
|---|---|---|
| Arthroscopic synovial brushingThe specific and novel surgical procedure that will be carried out here is synovial membrane brushing using a novel device that has been shown to release MSCs from the synovium in vitro. This technique will be carried out in the setting of therapeutic microfracture for cartilage defects. | Device | Intervention group |
| MicrofractureAlso: Marrow-stimulationMicrofracture or marrow-stimulation is a surgical procedure to repair small isolated cartilage defects by recruiting bone marrow mesenchymal stromal cells by creating small holes ('micro fractures') in the sub-chondral bone. These cells are entrapped in the ensuing blood clot and contribute to partial repair of the cartilage. | Procedure or surgery | Control group |
Primary outcome
The mean change in the number of MSCs present in the knee pre- and post- microfracture/microfracture plus arthroscopic synovial brushing.
Time frame: 2 weeds
5 secondary outcomes
Number of patients whose clinical effusion scores improve at 3, 6 and 12 months
Time frame: 3, 6 and 12 months
Number of patients whose semi-quantitative MRI cartilage scores improve at 6 and 12 months
Time frame: up to 12 months
Median KOOS scores at 3, 6 and 12 months (pain; other symptoms; function in daily living; function in sport; knee-related QoL; average score)
Time frame: 3, 6 and 12 months
Western Ontario and McMaster Universities Arthritis Index (WOMAC)
Time frame: 3, 6 and 12 months
Visual Analogue Scale (VAS)
Time frame: 3, 6 and 12 months
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 29 Nov 2023.
- 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.
Dennis G McGonagle, MB BcH BAO principal investigator
University of Leeds
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Arthroscopic synovial brushing and Microfracture in people with Defect of Articular Cartilage and Cartilage Injury, run by University of Leeds 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 2 inclusion and 12 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 29 Nov 2023. 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?
The mean change in the number of MSCs present in the knee pre- and post- microfracture/microfracture plus arthroscopic synovial brushing. (time frame: 2 weeds). 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 29 Nov 2023.