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.