Synovium Brushing to Augmented Microfracture for Improved Cartilage Repair (AURA)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02696876|
Recruitment Status : Recruiting
First Posted : March 2, 2016
Last Update Posted : June 4, 2018
|Condition or disease||Intervention/treatment||Phase|
|Defect of Articular Cartilage Cartilage Injury Osteoarthritis, Knee||Device: Arthroscopic synovial brushing Procedure: Microfracture||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|Official Title:||Safety and Efficacy of a Novel Synovium Brushing Method for Endogenous Mesenchymal Stem Cells Mobilisation During Knee Joint Microfracture for Cartilage Repair.|
|Study Start Date :||January 2017|
|Estimated Primary Completion Date :||July 2018|
|Estimated Study Completion Date :||July 2019|
Active Comparator: Control group
Patients in this group will received conventional microfracture treatment as indicated for isolated cartilage defects and defined by the inclusion criteria.
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.
Other Name: Marrow-stimulation
Experimental: Intervention group
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.
Device: Arthroscopic synovial brushing
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.
- 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 ]
- 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 ]Median WOMAC scores at 3, 6 and 12 months (total; pain; stiffness; function)
- Visual Analogue Scale (VAS) [ Time Frame: 3, 6 and 12 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02696876
|Contact: Dennis G McGonagle, FRCPI PhD||0113 firstname.lastname@example.org|
|Contact: Thomas G Baboolal, PhD||0113 email@example.com|
|Chapel Allerton Orthopaedic Centre, Leeds Teaching Hospitals NHS Trust||Recruiting|
|Leeds, West Yorkshire, United Kingdom, LS7 4SA|
|Contact: Owen R Wall, MB ChB|
|Contact: Alam Khalil-Khan, MBBS|
|Principal Investigator:||Dennis G McGonagle, MB BcH BAO||University of Leeds|