A Study to Evaluate the Safety of Augment™ Bone Graft

Inclusion Criteria:

• Prior Magnetic Resonance Imaging (MRI) evaluation or MRI on Screening.
• Subjects with Grade III osteochondral defect (OCD) of femoral condyle.
• Subjects with OCD > 1 cm.squared.
• Independent and ambulatory pts.
• Subjects from 18 to 40 years of age.
• Subject with a stable knee joint and similar stability on the opposite knee.
• Subject has knee x-ray with < 15 degrees of valgus and < 5 degrees varus.
• No deformity from previous fractures of tibia or fibula.
• BMI < 35.
• Subject has an American Association of Anaesthetists physical status classification of 1 or 2.
• Subject must present with pain > 3.0 cm according to the Visual Analogue Score.
• Subject has exhausted non operative treatment.

Exclusion:

• Allergy to yeast derived products.
• Index knee has had cartilage repair in the last six months.
• Subjects with osteoarthritis,inflammatory arthritis, rheumatoid arthritis and avascular necrosis of index knee.
• Subject has contralateral knee complications which would interfere with rehabilitation
• Subject has implanted metallic devices that would prevent Magnetic Resonance Imaging (MRI).
• Subject has claustrophobia that would prevent MRI.
• Subject has had a malignancy or is being treated for a malignancy.
• Subject is physically or mentally compromised that would interfere with compliance.
• Subject is a prisoner or transient.
• Subject has a recent history (12 months) of alcohol abuse.
• Subject is pregnant, able to become pregnant but not practising birth control.
• Subject has an infection in the operative area.
• Subject has scheduled surgery on the contralateral knee over the course of the study.
• Subject requires another procedure in the index knee.
• Subject has had steroid therapy in the past six months.
• Subject is taking prescription pain medication for another indication other than the index knee.
• Subject is using nicotine in any form.