Synovium Brushing to Augmented Microfracture for Improved Cartilage Repair

Status Completed

Clinical 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 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.

Clinical Trial 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

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT02696876
Study type	Interventional
Source	University of Leeds
Contact
Status	Completed
Phase	N/A
Start date	January 2017
Completion date	October 2023

View Details

See also
Status	Clinical Trial	Phase
Recruiting	`NCT03895489` - Effectiveness of the Journey Total Knee Arthroplasty Versus Two Standard of Care Total Knee Arthroplasty Prostheses	N/A
Completed	`NCT03660943` - A Clinical Study to Test Efficacy and Safety of Repeat Doses of CNTX-4975-05 in Patients With Osteoarthritis Knee Pain	Phase 3
Completed	`NCT04531969` - Comparison of Outpatient and Inpatient Spa Therapy	N/A
Completed	`NCT02848027` - Correlating the Osteoarthritic Knee Microenvironment to Clinical Outcome After Treatment With Regenexx®SD Treatment	Phase 3
Completed	`NCT05160246` - The Instant Effect of Kinesiology Taping in Patients With Knee OA	N/A
Recruiting	`NCT06080763` - Biomechanics and Clinical Outcomes in Responders and Non-Responders
Completed	`NCT03643588` - The Comparison of HYAJOINT Plus and Hyalgan Hyaluronan Supplement for Knee Osteoarthritis Pain	N/A
Active, not recruiting	`NCT05100225` - Efficacy and Safety Trial of PTP-001 (MOTYS) for Symptomatic Knee Osteoarthritis	Phase 2
Active, not recruiting	`NCT04061733` - New Hydroxyethyl Cellulose Hydrogel for the Treatment of the Pain of Knee Arthrosis	N/A
Completed	`NCT04051489` - A Novel Smartphone Application for "Smart" Knee Osteoarthritis Trials
Recruiting	`NCT05546541` - Epidemiology and Nutrition
Recruiting	`NCT05447767` - Prediction AlgoriThm for regeneraTive Medicine Approach in knEe OA: New Decision-making Process Based on Patient pRofiliNg	Phase 2
Not yet recruiting	`NCT04448106` - Autologous Adipose Tissue-Derived Mesenchymal Stem Cells (AdMSCs) for Osteoarthritis	Phase 2
Not yet recruiting	`NCT03225911` - Effect of a Lateral Wedge Insole and Simple Knee Sleeve in Individuals With Knee Osteoarthritis	N/A
Completed	`NCT05070871` - A Clinical Trial Investigating the Effect of Salmon Bone Meal on Osteoarthritis Among Men and Women	N/A
Completed	`NCT05703087` - Positive Cueing in Knee Arthroplasty.	N/A
Not yet recruiting	`NCT06042426` - Effects of Perioperative Intravenous Dexamethasone in Clinical Outcomes After Total Knee Arthroplasty in a Hispanic Population	Phase 4
Terminated	`NCT02909257` - Motor-Sparing Femoral Nerve Block Dose	Phase 4
Terminated	`NCT02615522` - Prospective Post Market Clinical Follow-Up of the Primary Knee Endoprosthesis BPK-S Integration
Completed	`NCT03037489` - A Study to Evaluate Safety and Tolerability of MIV-711 in Osteoarthritis Patients	Phase 2

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Synovium Brushing to Augmented Microfracture for Improved Cartilage Repair — AURA

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms