FAQs

Frequently Asked Questions (FAQs)


PRODUCT OVERVIEW

What is ProChondrix® CR?

ProChondrix® CR, a laser-etched, cryopreserved fresh osteochondral allograft, helps deliver the necessary components for articular cartilage restoration. This next generation of cartilage restoration therapy provides the live functional cells and other biological components necessary for repair and regeneration of damaged cartilage tissues.1

  • The extracellular matrix helps support a structure for cellular migration and adhesion while preserving native growth factors.1
  • Presence of native growth factors help maintain healthy cartilage and facilitate chondrocyte functionality.1
  • Viable chondrocytes are present and can aid in cartilage repair by generating extracellular matrix proteins that help promote chondrogenesis.1

1. Delaney, R, Barrett, C, Stevens, P. AlloSource, Centennial, CO. ProChondrix® CR Cartilage Restoration Matrix Contains Growth Factors Necessary for Hyaline Cartilage Regeneration.

What is a chondrocyte?

A chondrocyte is a cell type found in articular cartilage that is essential for its proper functioning.

What is a proteoglycan?

A proteoglycan is a protein that is attached to a carbohydrate and is a major component in forming the extracellular matrix of connecting tissues.

What is the regulatory status for ProChondrix® CR?

ProChondrix® CR is FDA regulated as a human cell, tissue, and cellular and tissue-based product or HCT/P. The Center for Biologics Evaluation and Research (CBER) regulates HCT/Ps under 21 CFR Part 1271. AlloSource is registered as a tissue bank by the FDA [registration number FEI: 3000215346].

What sizes does ProChondrix® CR come in?

ProChondrix is offered in 9mm, 11mm, 13mm, 15mm, 17mm, and 20mm diameter discs.


 HANDLING & SHIPPING

How is ProChondrix® CR stored?

Store at or below -40°C.

How is ProChondrix® CR shipped?

ProChondrix® CR is shipped in validated temperature controlled shippers.

How do I order ProChondrix® CR?

Contact your local Stryker Sports Medicine Representative or Stryker Trauma & Extremities Representative


TECHNIQUE

Is ProChondrix® CR orientated?

Superficial orientation is easily recognized by a smooth articulating cartilage surface. The deep layer of the ProChondrix® CR graft is identified by a laser etching.

Can I cut the ProChondrix® CR to fit the defect?

Yes, if there is not a sizing option that fits the defect, there is no harm in cutting the graft to shape.

Can I use ProChondrix® CR if there is underlying bone damage?

If the patient has damage to the subchondral bone, the ProChondrix® CR graft should not be implanted until the subchondral bone damage has been repaired.

What should I use to fill the bony defect?

The bony defect should be repaired as you would normally repair subchondral bone damage.

How do I attach ProChondrix® CR to the recipient site?

ProChondrix® CR can be secured with fibrin glue and can be coupled with small sutures, anchors or darts if preferred.

What should I do if the lesion is on a corner?

When the lesion is on a corner, the site will still need to be debrided to ensure a clean surface area but the graft can be cut to fit the dimensions of the defect after it is curetted and debrided of the dead cartilage.

Is there any specific post-operative protocol?

Standard protocol for cartilage repair procedures is appropriate to follow for ProChondrix.

Why is ProChondrix® CR different from microfracture alone?

With a microfracture procedure, the picks are stimulating a blood clot to form in the defect space. Over time, this blood clot will begin to adapt properties of the surrounding host cartilage but will not fully regenerate to healthy hyaline cartilage composed of type II collagen but rather will develop a fibrous structure native to type I collagen.

Do I have to use marrow stimulation with ProChondrix® CR?

There has been clinical experience to date with and without microfracture.