Comparison of BioCart™II With Microfracture for Treatment of Cartilage Defects of the Femoral Condyle

Inclusion Criteria:

• Age 16 to 60 years
• Femoral condyle lesion (medial, lateral or trochlea)
• Single contained lesion
• Symptomatic (moderate to severe pain on VAS)
• Caused by trauma or OCD
• Depth of lesion up to 6 mm
• Size of lesion 1.5-7.5 cm2
• No general bone or cartilage pathology
• No limb mal-alignment (long leg standing X-ray)
• Mechanically stable knee
• Accompanying pathology menisectomy up to 50%
• Willing and able to comply with protocol and undergo vigorous rehabilitation
• Signed informed consent

Exclusion Criteria:

• Multiple cartilage lesions of the knee, other location than femoral condyle (medial, lateral or trochlear), deeper than 6 mm, smaller than 1.5cm2 or greater than 7.5cm2, mild symptoms, caused by reason other than trauma or OCD, unstable knee, accompanying pathology other than 50% menisectomy.
• Hyaluronic acid knee injections in the past 3 months,
• History of chronic bone or cartilage disorder, bilateral knee pain and/or cartilage lesion
• History of any neoplastic disease, or chemotherapy treatment
• Chronic steroid intake, chronic pain medication use for conditions other than the involved knee, use of blood thinners (during the past 10 days prior to enrollment)
• History of allergy or atopic disease, sensitivity to blood products
• Evidence of any significant systemic disease, known coagulopathies or acute injury that might compromise the patient's welfare
• Pregnant or lactating women
• Substance or alcohol abuse
• Microfracture to the affected knee within the previous 2 years
• Participation in concurrent trials
• Participation in previous trials within 3 months
• Malignancy
• Taking specific drugs for osteoarthritis, such as chondroitin sulfate, diacerein, n-glucosamine, piaseledine, or capsaicin within 2 weeks of the baseline visit
• Chronic use of anticoagulants
• Uncontrolled diabetes
• Active joint infection
• Other unstable cardiac and pulmonary disorder
• Liver enzymes (SGOT, SGPT, alkaline phosphatase) of more then two times the upper limit of normal or any other results that in the clinical investigator's mind is important clinically
• Clinical and/or radiographic disease in the indexed affected joint that includes:
• Osteoarthritis or avascular necrosis
• Rheumatoid arthritis or a history of septic or reactive arthritis
• Gout or a history of gout or pseudogout in the affected knee
• Osteochondritis dissecans of the knee with significant bone loss
• Bipolar articular cartilage involvement (or kissing lesions) of the ipsilateral compartment (i.e >than ICRS grade 2 on the opposing articular surface)
• Associated damage to the underlying subchondral bone requiring an osteochondral graft
• History of secondary arthropathies (i.e. sickle cell disease, Hemochromatosis, or autoimmune disease)
• Receiving prescription pain medication other than NSAIDs or acetaminophen for conditions unrelated to the index knee conditions
• BMI >40 kg/m2
• Unable to undergo MRI
• Any reasons making the patient a poor candidate in the eyes of the investigator