Implantation of Engineered Cartilage Grafts for Treatment of Patellofemoral Osteoarthritis Versus Surgical Comparators.
NCT Number: NCT06576583
Acronym: ENCANTO
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Patellofemoral Osteoarthritis
Interventions: BIOLOGICAL: Engineered cartilage graft (N-TEC)|PROCEDURE: Autologous Matrix Induced Chondrogenesis (AMIC)|PROCEDURE: Patellofemoral Arthroplasty (PFA)
Sponsor: University Hospital, Basel, Switzerland
Collaborators: Clinical Trial Unit, University Hospital Basel, Switzerland|Wuerzburg University Hospital|Medical University of Vienna|Videoreha|University of Oulu|Theracell Laboratories|Promove-Biotec GmbH|Maastricht University|Foundation National Reumafonds|Angry@Arthritis|University of Miami|Geistlich Pharma AG|European Union
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 150
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: TREATMENT
Start Date: 2025-01
Completion Date: 2030-01
Locations: Orthopedic Hospital Vienna-Speising, Wien, 1130, Austria|University Hospital Sveti Duh, Zagreb, 10000, Croatia|Evangelisches Waldkrankenhaus Spandau, Berlin, 13589, Germany|Orthopedic Clinic König-Ludwig-Haus, Würzburg, 97074, Germany|IRCCS Ospedale Galeazzi-Sant'Ambrogio, Milan, 20157, Italy|Fondazione Policlinico Universitario Campus Bio-Medico, Rome, 00128, Italy|Maastricht University Medical Center, Maastricht, 6229 HX, Netherlands|Zeromski hospital, Krakow, 31-913, Poland|Department of Orthopaedics, University of Gothenburg (UGOT), Mölndal, 80, Sweden|Crossklinik, Basel, 4054, Switzerland

Summary:
ENCANTO is a randomized, controlled, multi-center phase II clinical trial for the treatment of patellofemoral osteoarthritis (PFOA) with an Advanced Therapy Medicinal Product (ATMP), nasal chondrocyte-based tissue engineered cartilage (N-TEC) implantation in comparison with current standard of care depending on the stage of osteoarthritis. The goal of this phase II trial is to evaluate the efficacy of N-TEC treatment in comparison to an active comparator Autologous Matrix Induced Chondrogenesis (AMIC) for early stage PFOA or patellofemoral arthroplasty (PFA) for late stage PFOA.

The N-TEC engineered cartilage graft is obtained by culturing expanded autologous nasal chondrocytes within a collagen type I/III membrane.

Primary Outcome Measures: Knee Injury and Osteoarthritis Outcome Score (KOOS) for pain, Difference in 2-year change (baseline to 24 month follow-up) in the KOOS pain score between patients undergoing N-TEC tissue implantation and patients receiving AMIC or PFA. Minimum score: 0 Maximum score: 100 (higher score means no knee problems), 24 months
Secondary Outcome Measures: Knee Injury and Osteoarthritis Outcome questionnaire, patient self reported questionnaire for pain, until 12 months|Knee Injury and Osteoarthritis Outcome questionnaire, patient self reported questionnaire for symptoms, activity of daily life, sports and quality of life Minimum score: 0 Maximum score: 100 (higher score means no knee problems), Until 24 months|Kujala questionnaire, patient self reported questionnaire for Anterior Knee Pain scale. Minimum score: 0 Maximum score: 100 (no knee problems), Until 24 months|Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) score, Self reported questionnaire to evaluate the condition of patients with osteoarthritis of the knee and hip, including pain, stiffness, and physical functioning of the joints.

The instrument contains 24 items measuring 3 sub-scales: physical function (17 items), pain (5 items), and stiffness (2 items). Minimum score: 0 (no knee problems) Maximum score: 96 (worst knee problems), Until 24 months|EQ-5D-5L questionnaire, Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems., Until 24 months|Global Rating Of Change (GROC) likert scale, Widely used score to assess whether the patient condition has gotten worse, better, or stayed the same and to quantify the magnitude of that change. Minimum score: -5 ; maximal score: +5., Until 24 months|Marx Activity Rating Scale (MARS) score, This activity-related patient-reported outcome measure is widely used to assess the activity of a patient after treatments of the knee. It assesses how often the patient performs activities (running, cutting, deceleration and pivoting) in his healthiest and more active state. Minimum score: 0; maximum score: 16., Until 24 months|Morphological analysis, Morphological analysis with assessment of whole cartilage volume (in mm3) by radiological assessment (MRI), Until 24 months|Collagen network organization, Collagen network organization with T2 mapping and RADIOMICS GLCM by radiological assessment (MRI), Until 24 months|Osteoarthritis grading, Osteoarthritis grade according to Iwano and Kellgren/Lawrence classification by radiological assessment (X-ray), Until 24 months|Biovigilance, Number of adverse events, adverse reactions based on severity, expectedness and relationship to treatment., Until 24 months