Clinical trial NCT02696876: Synovium Brushing to Augmented Microfracture for Improved Cartilage Repair
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Defect of Articular Cartilage
Cartilage Injury
Osteoarthritis, Knee
Keywords: Cartilage
Mesenchymal stromal cell
Microfracture
Knee
Defect
Injury
Stem cell
Autologous
Minimally manipulated
Lead sponsor: University of Leeds
Sponsor class: OTHER
Collaborators: name: The Leeds Teaching Hospitals NHS Trust
First posted: 2016-03-02
Enrollment: 4
Sex: ALL
Minimum age (years): 16
Maximum age (years): 55
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility 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

Primary outcomes:
measure: The mean change in the number of MSCs present in the knee pre- and post- microfracture/microfracture plus arthroscopic synovial brushing.
timeFrame: 2 weeds
Secondary outcomes:
measure: Number of patients whose clinical effusion scores improve at 3, 6 and 12 months
timeFrame: 3, 6 and 12 months
measure: Number of patients whose semi-quantitative MRI cartilage scores improve at 6 and 12 months
timeFrame: up to 12 months
measure: Median KOOS scores at 3, 6 and 12 months (pain; other symptoms; function in daily living; function in sport; knee-related QoL; average score)
timeFrame: 3, 6 and 12 months
measure: Western Ontario and McMaster Universities Arthritis Index (WOMAC)
timeFrame: 3, 6 and 12 months
measure: Visual Analogue Scale (VAS)
timeFrame: 3, 6 and 12 months
Other outcomes:
Locations:
city: Leeds
country: United Kingdom
facility: Chapel Allerton Orthopaedic Centre, Leeds Teaching Hospitals NHS Trust
state: West Yorkshire
Study officials:
affiliation: University of Leeds
name: Dennis G McGonagle, MB BcH BAO
role: PRINCIPAL_INVESTIGATOR
References: