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

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ClinicalTrials.gov Identifier: NCT02696876
Recruitment Status : Recruiting
First Posted : March 2, 2016
Last Update Posted : June 4, 2018
Sponsor:
Collaborator:
The Leeds Teaching Hospitals NHS Trust
Information provided by (Responsible Party):
Dennis McGonagle, University of Leeds

Brief 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.

Condition or disease Intervention/treatment Phase
Defect of Articular Cartilage Cartilage Injury Osteoarthritis, Knee Device: Arthroscopic synovial brushing Procedure: Microfracture Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


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 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.




Primary Outcome Measures :
  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 Outcome Measures :
  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 ]


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Ages Eligible for Study:   16 Years to 55 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

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


Contacts
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Contact: Dennis G McGonagle, FRCPI PhD 0113 3924747 d.g.mcgonagle@leeds.ac.uk
Contact: Thomas G Baboolal, PhD 0113 3438413 t.baboolal@leeds.ac.uk

Locations
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United Kingdom
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         
Sponsors and Collaborators
University of Leeds
The Leeds Teaching Hospitals NHS Trust
Investigators
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Principal Investigator: Dennis G McGonagle, MB BcH BAO University of Leeds

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Responsible Party: Dennis McGonagle, Profession of Regenerative Medicine, University of Leeds
ClinicalTrials.gov Identifier: NCT02696876     History of Changes
Other Study ID Numbers: RR15/173
First Posted: March 2, 2016    Key Record Dates
Last Update Posted: June 4, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Dennis McGonagle, University of Leeds:
Cartilage
Mesenchymal stromal cell
Microfracture
Knee
Defect
Injury
Stem cell
Autologous
Minimally manipulated

Additional relevant MeSH terms:
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Arthritis
Fractures, Bone
Osteoarthritis
Osteoarthritis, Knee
Fractures, Stress
Cartilage Diseases
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Wounds and Injuries
Connective Tissue Diseases