Patient Diagnosis & Assessment

Clinically appropriate CARTICEL^® candidates are patients with articular cartilage damage in the femoral condyle (medial, lateral, trochlear). Clinically appropriate CARTICEL candidates are typically identified in one of two ways:

• You may identify a patient as a clinically appropriate candidate for CARTICEL based on his or her symptoms and prior surgical history. In this case, the first step is to perform a diagnostic arthroscopy during which you will take a cartilage biopsy.

• In other cases, you may discover a significant chondral lesion during an arthroscopy for another knee repair procedure, such as an ACL reconstruction. If the patient has failed a prior procedure to treat a symptomatic cartilage injury, and you think the patient may be a candidate for treatment with CARTICEL, you can take a cartilage biopsy during that procedure.

In all cases, once you have obtained a biopsy, it must be sent to Genzyme Biosurgery for cell culturing. Once you have determined that the patient is a clinically appropriate candidate for CARTICEL and you and the patient have decided on CARTICEL as the treatment option, you can schedule your patient for the implantation procedure four to six weeks after cell culturing begins. The exact date for the procedure depends on the patient’s cell growth times.

Patient Assessment

As you are assessing whether a patient is a clinically appropriate candidate for CARTICEL, consider both physiological and psychological factors when determining whether CARTICEL is the right choice for him or her.

Joint Factors

• There is no size restriction on lesions treated with CARTICEL. The average lesion size treated with CARTICEL is 4 cm².¹ CARTICEL is recommended for patients who have had an inadequate response to a prior surgical procedure.

• Co-morbidities can exist, but should be treated prior to or concomitantly with CARTICEL implantation. This can include joint malalignment, ligament instability/deficiency, or meniscal pathology.

• The patient should have a relatively healthy joint; the defect should be contained or partially contained by healthy surrounding cartilage. Inspect opposing surface; patients with bipolar lesions should not be considered. CARTICEL is not indicated for the treatment of cartilage damage associated with osteoarthritis.

Patient Factors

To help optimize good clinical outcomes and obtain the function and level of activity that the patient desires, it is important to have the patient understand the requirements and to set his or her expectations about rehabilitation.

References

1. Micheli, LJ, Browne JE, Erggelet C, Fu FH, Mandelbaum BR, Moseley JB, Zurakowski D. Autologous Chondrocyte Implantation of the Knee: Multicenter Experience and Minimum 3-Year Follow-Up. Clinical Journal of Sports Medicine. 2001 11:223-228.