Synovium Brushing to Augmented Microfracture for Improved Cartilage Repair

NCT02696876 | Completed

• 1 other identifier: RR15/173
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

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.

Conditions

Defect of Articular Cartilage; Cartilage Injury; Osteoarthritis, Knee

Keywords

Cartilage; Mesenchymal stromal cell; Microfracture; Knee; Defect; Injury; Stem cell; Autologous; Minimally manipulated

Outcome Measures

Primary Outcomes (1)

• The mean change in the number of MSCs present in the knee pre- and post- microfracture/microfracture plus arthroscopic synovial brushing.

  2 weeds

Secondary Outcomes (5)

• Number of patients whose clinical effusion scores improve at 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

  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)

  3, 6 and 12 months

• Western Ontario and McMaster Universities Arthritis Index (WOMAC)

  3, 6 and 12 months

• Visual Analogue Scale (VAS)

  3, 6 and 12 months

Study Arms (2)

Control group

ACTIVE COMPARATOR

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

Procedure: Microfracture

Intervention group

EXPERIMENTAL

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

Interventions

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.

Intervention group

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.

Also known as: Marrow-stimulation

Control group

Eligibility Criteria

• Age: 16 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Isolated cartilage defects (\<2cm2)
• Patients undergoing microfracture for repair of cartilage defects

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Leeds: lead
• The Leeds Teaching Hospitals NHS Trust: collaborator

Study Sites (1)

Chapel Allerton Orthopaedic Centre, Leeds Teaching Hospitals NHS Trust

Leeds, West Yorkshire, LS7 4SA, United Kingdom

Location

MeSH Terms

Conditions

Osteoarthritis, Knee; Fractures, Stress; Wounds and Injuries

Interventions

Arthroplasty, Subchondral

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Fractures, Bone

Intervention Hierarchy (Ancestors)

Arthroplasty; Orthopedic Procedures; Surgical Procedures, Operative; Plastic Surgery Procedures

Study Officials

• Dennis G McGonagle, MB BcH BAO

  University of Leeds

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Profession of Regenerative Medicine

Study Record Dates

• First Submitted: February 26, 2016
• First Posted: March 2, 2016
• Study Start: January 1, 2017
• Primary Completion: January 1, 2023
• Study Completion: October 1, 2023
• Last Updated: November 29, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)