Synovium Brushing to Augmented Microfracture for Improved Cartilage Repair (AURA)

November 28, 2023 updated by: Dennis McGonagle, University of Leeds

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

4

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United Kingdom
    • West Yorkshire
      • Leeds, West Yorkshire, United Kingdom, LS7 4SA
        • Chapel Allerton Orthopaedic Centre, Leeds Teaching Hospitals NHS Trust

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 55 years (Child, Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
Procedure: Microfracture
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 Names:
  • 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
2 weeds

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of patients whose clinical effusion scores improve at 3, 6 and 12 months
Time Frame: 3, 6 and 12 months
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
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
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)
3, 6 and 12 months
Visual Analogue Scale (VAS)
Time Frame: 3, 6 and 12 months
3, 6 and 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Leeds

Collaborators

The Leeds Teaching Hospitals NHS Trust

Investigators

  • Principal Investigator: Dennis G McGonagle, MB BcH BAO, University of Leeds

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2017

Primary Completion (Actual)

January 1, 2023

Study Completion (Actual)

October 1, 2023

Study Registration Dates

First Submitted

February 26, 2016

First Submitted That Met QC Criteria

March 1, 2016

First Posted (Estimated)

March 2, 2016

Study Record Updates

Last Update Posted (Actual)

November 29, 2023

Last Update Submitted That Met QC Criteria

November 28, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RR15/173

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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