Implantation Procedure

After the biopsy has been processed and Carticel is delivered to you, it’s time to begin the implantation procedure. This includes creating an optimal defect bed, preparing and placing a periosteal patch, and injecting Carticel into the defect.

As per the Carticel labeling, please note that the FDA mandates that all Carticel surgeons must be trained in the surgical procedure. The surgical procedure must be performed in accordance with the procedure outlined in the Carticel Surgical Manual.

Please note that the following information is designed to give you an overview of the implantation procedure. For complete information on the surgical technique, please refer to the Carticel Surgical Manual.

To treat an isolated defect on the medial or lateral femoral condyle, you may use a mini-arthrotomy. When treating multiple defects or defects that are more difficult to access, a traditional mid-line arthrotomy is recommended.

Defect Preparation

Healthy cartilage of normal thickness and resiliency must surround the defect.

Excise all damaged or unhealthy cartilage from the perimeter of the defect.

Then debride the base of the defect, removing all fibrous tissue and cartilage remnants. Take care not to penetrate subchondral bone.

Periosteum Procurement

Measure the defect at its widest (medial to lateral, and superior to inferior) points, then add 2 mm to both vertical and horizontal measurements to compensate for shrinkage of the periosteum after removal from the bone surface.

Use a small periosteal elevator to create an edge around the borders. Carefully remove the periosteum from the proximal medial posterior cortex of the tibia.

Key points:

  • A sterile paper template may aid periosteal patch sizing.
  • When treating multiple defects, mark each periosteal patch specifically for its intended location.
  • Keep the periosteum and surface cartilage moist at all times to decrease shrinkage and minimize harmful effects.
  • If the periosteum rips, suture it; if it is too small, harvest a second piece of tissue and suture it to the original piece.

Periosteum Fixation

Prior to affixing the patch, let the tourniquet down and ensure the defect base is free of tissue and bleeding. Bleeding from the bone surface may be controlled with application of fibrin glue at the source, or other haemostatic agents such as diluted epinephrine.

  • Fit the periosteum flush (not overlapping) the defect with the glossy cambium layer facing towards the defect.
  • Use a 6.0 Vicryl suture, lubricated with mineral oil, to suture the periosteum to the defect rim.
  • Space sutures approximately 3 to 4 mm apart in a diametrically opposed z-pattern, distributing the tension of the periosteum and providing a secure, watertight seal. Ensure knots are not prominent to the condylar surface.
  • Apply fibrin glue around the rim of the sutured patch to ensure a watertight seal.
  • Leave a superior opening for injection of Carticel.

Periosteum Watertight Integrity Testing

A dry defect bed enhances chondrocyte adherence and prevents dilution of cells.

  • Inject sterile saline into the defect through the superior opening and inspect for leakage. Use additional sutures and/or fibrin glue to address any remaining leakage.
  • Once a watertight seal is achieved, aspirate all remaining saline from under the periosteum.

Implanting Carticel

  • Using strict sterile technique, aspirate the cells in the medium multiple times to distribute the cells evenly within the medium.
  • When cell particles are no longer apparent, and the medium is a consistent, cloudy mixture, aspirate all contents of the vial into the catheter.
  • Insert catheter to the most inferior aspect of the defect and slowly inject the cells while moving the catheter tip from side to side and withdrawing the catheter. This will ensure even cell distribution.
  • Close the superior opening of the periosteum with additional sutures and fibrin glue.