N-TEC: Implantation of an autologous tissue engineered cartilage graft in the patellofemoral joint for treatment of osteoarthritis.
Platelet rich plasma: Injection of an autologous Conditioned Plasma ACP® on the basis of one injection per week for three consecutive weeks.
Conditioned Plasma ACP®, Arthrex, one injection per week for three consecutive weeks.
Study summary
The purpose of this investigator-initiated study is to assess the efficacy of treating patellofemoral osteoarthritis with an Advanced Therapy Medicinal Product (ATMP), autologous nasal chondrocyte tissue engineered cartilage (N-TEC), in comparison with a standard therapy using platelet rich plasma injections.
The engineered cartilage graft is obtained by culturing expanded autologous nasal chondrocytes within a collagen type I/III membrane.
Eligibility
Sex
ALL
Min age
18 Years
Max age
65 Years
Healthy volunteers
No
Inclusion Criteria:
* 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.
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 unable to understand the patient information
* 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°)
* 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
* 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 immunosuppressives.
* Patient had any intra-articular injections into the affected knee within the last 3 months before baseline visit
* Instability of anterior, posterior 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 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 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.
* Any known allergies, especially for porcine collagen, penicillin or streptomycin (manufacturing)
* 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
Primary outcome measure(s)
Knee Injury and Osteoarthritis Outcome Score (KOOS) for pain — 24 months mean change in Knee Injury and Osteoarthritis Outcome Score for pain from baseline to 24 months between groups Minimum score: 0 Maximum score :100 (higher score means no knee problems)
Trial sites (9)
Facility
City
Region
Status
Poliklinika Ivković
Zagreb
Croatia
Recruiting
Poliklinika Ortho Plus
Zagreb
Croatia
Recruiting
Universitätsklinikum Freiburg
Freiburg im Breisgau
Germany
Not Yet Recruiting
Orthopädische Klinik König-Ludwig-Haus
Würzburg
Germany
Not Yet Recruiting
University Hospital Basel
Basel
Switzerland
Recruiting
Crossklinik
Basel
Switzerland
Recruiting
Hôpitaux universitaires de Genève
Geneva
Switzerland
Recruiting
Ospedale Regionale di Lugano
Lugano
Switzerland
Recruiting
Sportclinic, Klinik Hirslanden
Zurich
Switzerland
Recruiting
More University Hospital, Basel, Switzerland trials in Germany
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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