Osteoarthritis, Knee Clinical Trial
— AURAOfficial title:
Safety and Efficacy of a Novel Synovium Brushing Method for Endogenous Mesenchymal Stem Cells Mobilisation During Knee Joint Microfracture for Cartilage Repair.
NCT number | NCT02696876 |
Other study ID # | RR15/173 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | January 2017 |
Est. completion date | October 2023 |
Verified date | November 2023 |
Source | University of Leeds |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 4 |
Est. completion date | October 2023 |
Est. primary completion date | January 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 16 Years to 55 Years |
Eligibility | Inclusion Criteria: - Isolated cartilage defects (<2cm2) - Patients undergoing microfracture for repair of cartilage defects Exclusion Criteria: - Septic arthritis - Infectious disease - Revision joint surgery - Meniscal damage requiring repair - Ligament damage requiring repair - Cartilage defect greater than 2cm2 - 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 |
Country | Name | City | State |
---|---|---|---|
United Kingdom | Chapel Allerton Orthopaedic Centre, Leeds Teaching Hospitals NHS Trust | Leeds | West Yorkshire |
Lead Sponsor | Collaborator |
---|---|
University of Leeds | The Leeds Teaching Hospitals NHS Trust |
United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The mean change in the number of MSCs present in the knee pre- and post- microfracture/microfracture plus arthroscopic synovial brushing. | 2 weeds | ||
Secondary | Number of patients whose clinical effusion scores improve at 3, 6 and 12 months | 3, 6 and 12 months | ||
Secondary | Number of patients whose semi-quantitative MRI cartilage scores improve at 6 and 12 months | up to 12 months | ||
Secondary | Median KOOS scores at 3, 6 and 12 months (pain; other symptoms; function in daily living; function in sport; knee-related QoL; average score) | 3, 6 and 12 months | ||
Secondary | Western Ontario and McMaster Universities Arthritis Index (WOMAC) | Median WOMAC scores at 3, 6 and 12 months (total; pain; stiffness; function) | 3, 6 and 12 months | |
Secondary | Visual Analogue Scale (VAS) | 3, 6 and 12 months |
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