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Completed

NCT Number: NCT02696876

Synovium Brushing to Augmented Microfracture for Improved 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.

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Key information

Conditions

Defect of Articular Cartilage Arthritis Cartilage Injury Fractures, Bone Fractures, Stress Joint Diseases Musculoskeletal Diseases Osteoarthritis Osteoarthritis, Knee Rheumatic Diseases Wounds and Injuries

Age range

16 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Chapel Allerton Orthopaedic Centre, Leeds Teaching Hospitals NHS Trust

Leeds, West Yorkshire, LS7 4SA, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Arthroscopic synovial brushing

Device

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.

Microfracture

Procedure

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

Primary outcomes

  1. 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

Secondary outcomes

  1. Number of patients whose clinical effusion scores improve at 3, 6 and 12 months

    Time frame: 3, 6 and 12 months

  2. Number of patients whose semi-quantitative MRI cartilage scores improve at 6 and 12 months

    Time frame: up to 12 months

  3. 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

  4. 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)

  5. Visual Analogue Scale (VAS)

    Time frame: 3, 6 and 12 months

Sponsors and collaborators

Lead sponsor

University of Leeds

Other

Collaborators

  • The Leeds Teaching Hospitals NHS Trust

Registry information

Official study title

Safety and Efficacy of a Novel Synovium Brushing Method for Endogenous Mesenchymal Stem Cells Mobilisation During Knee Joint Microfracture for Cartilage Repair.

Acronym: AURA

Important dates

Study start
2017
Primary completion
2023
Study completion
2023
First posted
Mar 2, 2016
Registry last updated
Nov 29, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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