Implantation of Engineered Cartilage Grafts for Treatment of Patellofemoral Osteoarthritis Versus Surgical Comparators.

Exclusion Criteria

• •Patient is the investigator or any sub-investigator, research assistant, pharmacist, study coordinator, other staff or relative thereof directly involved in the conduct of the protocol or in a dependency or employment with the sponsor.
• •Patient is unwilling, unable or lacking the capacity to provide informed consent
• •Patient is unable to undergo magnetic resonance imaging (MRI)
• •Prior surgical treatment of the target knee within 12 months (Note: prior diagnostic arthroscopy with debridement and lavage are acceptable within 12 months).
• •Radiologically apparent degenerative joint disease of the tibiofemoral joint as determined by X-ray (Kellgren and Lawrence grade \> 2) or MRI or pain in the tibiofemoral joint as assessed by clinical examination
• •Patient has excessive varus or valgus deformity (\>5°), unless corrected during implantation
• •Patient has a symptomatic meniscus lesion (or removal exceeding ½), as indicated by clinical examination (joint line tenderness and McMurray test positive) and MRI.
• •Patient has a body mass index (BMI) \>35 kg/m2.
• •Patient has chronic rheumatoid arthritis, and/or infectious arthritis
• •Any concomitant painful or disabling disease of the spine, hips, or lower limbs that would interfere with evaluation of the afflicted knee.
• •Patient has a known immunological suppressive disorder or is taking systemic immunosuppressives.
• •Patient had any intra-articular injections into the affected knee within the last 3 months before baseline visit
• •Instability of anterior, posterior and/or collateral ligaments
• •The patient has a HIV/AIDS infection. (regulatory requirement)
• •The patient has an acute Treponema pallidum (syphilis) infection. (regulatory requirement)
• •The patient has an active hepatitis B or C infection with verified antigens. Patients with a cured hepatitis B or C infection and/or verified antibodies are not excluded. (regulatory requirement)
• •Patient is pregnant, breast feeding or anticipates becoming pregnant within 24 months after surgery.
• •Patient is currently participating or has participated in any other clinical study within 3 months prior to the screening visit.
• •Patient has known current or recent history of illicit drug or alcohol abuse or dependence defined as the continued use of alcohol or drugs despite the development of social, legal or health problems.
• •Patient has any other condition, which, in the opinion of the investigator, would make the patient unsuitable for the study.
• •Known allergies for porcine collagen (scaffold), penicillin or streptomycin (manufacturing)
• •Nail-patella syndrome
• •Patients who will likely benefit from conservative therapy, such as physiotherapy, medical training therapy and pain medication
• •Patients with increased anesthesiological and surgical risks (e.g. known or predicted difficult airway, myocardial infarction \<60 days prior to surgery)
• •Patients with increased bleeding risk (e.g. coagulopathies)
• •Patients on anticoagulants whose anticoagulant therapy cannot be interrupted as appropriate to the given agent(s) and underlying condition
• •Patients with any active infections