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

Inclusion Criteria:

• Patient age is ≥18 and ≤ 70 years at time of screening.

• Symptomatic PFOA grade 1-4 according to Iwano Classification

• Chondropathy Grade 3-4 according to ICRS classification of the patella, trochleafemoris or both

• Baseline score of <60 on the KOOS Pain subjective knee evaluation.

• Free range of motion of the affected knee joint or ≤ 5° of extension loss andminimum 125° flexion.

• Patient is willing and able to give written informed consent to participate in thestudy and to comply with all study requirements, including attending all follow-upvisits and assessments and to complete postoperative rehabilitation regimen.

Exclusion Criteria:

• Patient is the investigator or any sub-investigator, research assistant, pharmacist,study coordinator, other staff or relative thereof directly involved in the conductof 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 diagnosticarthroscopy with debridement and lavage are acceptable within 12 months).

• Radiologically apparent degenerative joint disease of the tibiofemoral joint asdetermined by X-ray (Kellgren and Lawrence grade > 2) or MRI or pain in thetibiofemoral joint as assessed by clinical examination

• Patient has excessive varus or valgus deformity (>5°), unless corrected duringimplantation

• Patient has a symptomatic meniscus lesion (or removal exceeding ½), as indicated byclinical 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 thatwould interfere with evaluation of the afflicted knee.

• Patient has a known immunological suppressive disorder or is takingimmunosuppressives.

• Patient had any intra-articular injections into the affected knee within the last 3months 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. (regulatoryrequirement)

• 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 notexcluded. (regulatory requirement)

• Patient is pregnant, breast feeding or anticipates becoming pregnant within 24months after surgery.

• Patient is currently participating or has participated in any other clinical studywithin 3 months prior to the screening visit.

• Patient has known current or recent history of illicit drug or alcohol abuse ordependence defined as the continued use of alcohol or drugs despite the developmentof social, legal or health problems.

• Patient has any other condition, which, in the opinion of the investigator, wouldmake the patient unsuitable for the study.

• Any known allergies, especially for porcine collagen, penicillin or streptomycin (manufacturing)

• Nail-patella syndrome