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Synovium Brushing to Augmented Microfracture for Improved Cartilage Repair

NCT ID: NCT02696876

Last Updated: 2023-11-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

4 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-01-31

Study Completion Date

2023-10-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Defect of Articular Cartilage Cartilage Injury Osteoarthritis, Knee

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Control group

Patients in this group will received conventional microfracture treatment as indicated for isolated cartilage defects and defined by the inclusion criteria.

Group Type ACTIVE_COMPARATOR

Microfracture

Intervention Type 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.

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.

Group Type EXPERIMENTAL

Arthroscopic synovial brushing

Intervention Type 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.

Interventions

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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.

Intervention Type DEVICE

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.

Intervention Type PROCEDURE

Other Intervention Names

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Marrow-stimulation

Eligibility Criteria

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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
Minimum Eligible Age

16 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The Leeds Teaching Hospitals NHS Trust

OTHER

Sponsor Role collaborator

University of Leeds

OTHER

Sponsor Role lead

Responsible Party

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Dennis McGonagle

Profession of Regenerative Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Dennis G McGonagle, MB BcH BAO

Role: PRINCIPAL_INVESTIGATOR

University of Leeds

Locations

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Chapel Allerton Orthopaedic Centre, Leeds Teaching Hospitals NHS Trust

Leeds, West Yorkshire, United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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RR15/173

Identifier Type: -

Identifier Source: org_study_id