Articular cartilage damage
Damage to knee cartilage can occur from trauma to the knee or while playing sports, exercising, working or simply performing everyday activities. Chronic knee pain is common. In addition to pain, symptoms such as swelling, clicking, locking and catching can limit even simple tasks such as climbing stairs. The source of these problems may indicate a knee cartilage injury.
Cartilage does not have the ability to heal on its own. Normally, blood vessels bring nutrients and cells to help heal an injured area. Cartilage doesn’t have blood vessels, so it can’t heal itself. Damaged cartilage can irritate the joint, which may become inflamed and painful. When the injury is large enough, the cartilage no longer protects the bone underneath it; the pain increases, and if the injury is not treated it may get worse.
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Paulina Ramirez
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Paulina Ramirez loves to dance. She smiles, "It’s the way I socialize with my friends. It’s the way I release stress. It’s the way I get energy. It’s the way I enjoy life."
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Important Safety Information
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 (≥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).