Treatment of Patellofemoral Osteoarthritis With Engineered Cartilage.

Ki vehet részt

• Patient age is ≥18 and ≤ 65 years at time of screening
• Symptomatic PFOA grade 1-3 according to Iwano Classification
• Chondropathy Grade 3-4 according to ICRS classification of the patella, trochlea femoris 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 and minimum 125° flexion
• Patient is willing and able to give written informed consent to participate in the study and to comply with all study requirements, including attending all follow-up visits and assessments and to complete postoperative rehabilitation regimen
• Minimum values for women: Haemoglobin 110g/l, Platelets 150G/l, INR<1.3
• Minimum values for men: Haemoglobin 120g/l, Platelets 150G/l, INR<1.3
• Non-surgical standard of care options except for PRP have been exhausted

Ki nem vehet részt

• Prior surgical treatment of the target knee within 12 months (Note: prior diagnostic arthroscopy with debridement and lavage are acceptable within 12 months)
• Any concomitant painful or disabling disease of the spine, hips, or lower limbs that would interfere with evaluation of the afflicted knee
• Patient had any intra-articular injections into the affected knee within the last 3 months before baseline visit
• 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
• patients with increased anesthesiological and surgical risks (e.g. known or predicted difficult airway, myocardial infarction <60 days prior to surgery)
• 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 a known immunological suppressive disorder or is taking immunosuppressives
• The patient has a HIV/AIDS infection. (regulatory requirement)
• The patient has an acute Treponema pallidum (syphilis) infection. (regulatory requirement)
• 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
• Any known allergies, especially for porcine collagen, penicillin or streptomycin (manufacturing)
• 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
• The patient has an active hepatitis B or C infection assessed according to local laboratory standards using an antibody test and if positive, confirmatory test for active infection. Patients with a cured hepatitis B or C infection are not excluded. (regulatory requirement)
• 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 unable to understand the patient information
• Patient is unable to undergo magnetic resonance imaging (MRI)
• Patient has excessive varus or valgus deformity (>5°)
• Patient had a patellar dislocation in the afflicted knee in the last 2 years
• 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
• Instability of anterior, posterior collateral ligaments