PATIENTS

Learning About Your Knee Condition

Treating Damaged Cartilage

What To Expect

Pre-Surgery

Surgery

Physical Therapy

Explanation of Benefits

Frequently Asked Questions

Surgeon Locator

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Patients > What To Expect > Surgery

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Surgery

We’ve provided a brief summary of the CARTICEL^® implant procedure below. Be sure to discuss the procedure in detail with your doctor ahead of time to ensure you are prepared for the surgery.

The CARTICEL Procedure

		In a separate arthroscopic surgery, a small biopsy of healthy cartilage is harvested and sent to Genzyme Biosurgery.
		In our state-of-the-art cell processing facility, chondrocyte growth and morphology are routinely monitored. To meet our high standards, our advanced systems ensure quality, cell viability, and safety.
		CARTICEL is delivered by courier hours before surgery.
		During implantation, the chondral defect is debrided back to healthy tissue.
		The periosteal patch, harvested from proximal tibia, is sutured into place.
		CARTICEL is implanted under the patch.

At the start of the procedure, an incision is made to expose the injury, and the damaged cartilage is removed.

The surgeon will then take a thin piece of tissue (periosteum) that covers your shin bone (tibia) to suture over the injury site.

Your cultured chondrocytes (CARTICEL) are injected under this water-tight patch.

During the months that follow, the cells continue to multiply, forming the building blocks of healthy cartilage and integrating with the surrounding cartilage. With time, the cells mature to form cartilage repair tissue.

After the Procedure

Immediately after your surgery, you will be brought to the recovery room where nurses will monitor you and help manage any pain you may have.

As the anesthesia wears off, you will probably feel tired and slightly disoriented, though the aftereffects of anesthesia can vary greatly from person to person.

Typically, your knee will be in a brace and a stocking. The brace will lock your knee in extension for 4 to 6 hours.

You could then be put in a continuous passive motion (CPM) machine.

Your doctor will likely recommend your leg remain braced when walking or standing, and even while you sleep, for the next two to three weeks--other than when you are using the CPM machine or doing rehab.

Before you leave the hospital, you may have the opportunity to have a physical therapist show you how to safely transfer from sitting to standing positions while placing minimal weight on your braced leg. You can also ask your doctor or other health care professional for assistance.

Discharge Criteria

A member of your medical team will see you to determine the timing of your discharge. Some of the discharge criteria are listed below:

Adequate pain management on oral medications

Absence of fever

Good mobility as determined by the therapist and nurses (ability to get in and out of bed, on and off the toilet, and in and out of the shower)

Ability to walk with crutches

Post-Surgery Follow-up

Most surgeons will require routine follow-up visits. The frequency of the visits will depend on your surgeon’s assessment of your particular case. Visits are often scheduled at 2, 4, and/or 6 weeks, 3 months, and 6 months.

CARTICEL is for autologous use and is indicated for the repair of symptomatic, cartilage defects of the femoral condyle (medial, lateral or trochlea), caused by acute or repetitive trauma, in patients who have had an inadequate response to a prior arthroscopic or other surgical repair procedure (e.g., debridement, microfracture, drilling/abrasion arthroplasty, or osteochondral allograft/autograft). CARTICEL should only be used in conjunction with debridement, placement of a periosteal flap and rehabilitation. The independent contributions of the autologous cultured chondrocytes and other components of the therapy to outcome are unknown. It is not indicated for the treatment of cartilage damage associated with generalized osteoarthritis. It is not recommended for patients whose knee meniscus has been surgically removed unless the patient has undergone surgical reconstruction prior to or concurrent with CARTICEL implantation.

Pre-existing conditions including meniscal tears, joint instability or malalignment of the joint should be corrected prior to or concurrent with CARTICEL implantation. It should not be used in patients with a known history of hypersensitivity to gentamicin, other aminoglycosides or materials of bovine origin. CARTICEL is not routinely tested for transmissible infectious diseases and may transmit disease to the healthcare provider handling CARTICEL. In addition, it should not be used in patients who have previously had cancer in the bones, cartilage, fat or muscle of the treated limb. Use in children, patients over age 65, or in joints other than the knee has not yet been assessed.

The occurrence of subsequent surgical procedures (SSPs), primarily arthroscopy, following CARTICEL implantation is common. In the Study of the Treatment of Articular Repair (STAR), forty-nine percent (49%) of patients underwent an SSP on the treated knee, irrespective of their relationship to CARTICEL, during the 4-year follow up. The most common serious adverse events (³ 5% of patients), derived from STAR, include arthrofibrosis/joint adhesions, graft overgrowth, chondromalacia or chondrosis, cartilage injury, graft complication, meniscal lesion, graft delamination, and osteoarthritis.

For more information on CARTICEL, please see the Package Insert (PDF).