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.
Knee osteoarthritis (OA) is one of the most common causes for pain and disability with over 260 million people affected worldwide. Recent studies found that knee OA often starts in the patello-femoral compartment of the knee (PFOA) and is diagnosed in \~39% of people with knee pain aged above 30 years. Thus, PFOA and progression to full OA plays a crucial role in the reduction of quality of life of many people and in the raise of healthcare costs. The goal of this multi-center phase II trial is to (i) 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 based on patient self-assessed questionnaires (Knee Injury and Osteoarthritis Outcome Score, KOOS) and (ii) verify the postulated mode of action, which is expected to be of regenerative nature and will be assessed by evaluation of disease-modification by x- ray and structural regeneration of the osteoarthritic joint destruction by MRI analysis. A total of 150 patients with early stage of PFOA (Iwano grade 1-2; 75 patients) or late stage of PFOA (Iwano grade 3-4; 75 patients) will be enrolled in 11 clinical centers and randomized to either N-TEC implantation or active comparator (AMIC or PFA).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
150
Nasal chondrocytes based tissue engineered cartilage
Autologous Matrix Induced Chondrogenesis is performed through bone drilling and covering with Chondro-Gide® to attract bone marrow stem cells
Surgical implantation of a medical device, Zimmer Gender Solutions Patellofemoral Joint Prosthesis.
Orthopedic Hospital Vienna-Speising
Vienna, Austria
RECRUITINGUniversity Hospital Sveti Duh
Zagreb, Croatia
NOT_YET_RECRUITINGEvangelisches Waldkrankenhaus Spandau
Berlin, Germany
NOT_YET_RECRUITINGOrthopedic Clinic König-Ludwig-Haus
Würzburg, Germany
NOT_YET_RECRUITINGIRCCS Ospedale Galeazzi-Sant'Ambrogio
Milan, Italy
NOT_YET_RECRUITINGFondazione Policlinico Universitario Campus Bio-Medico
Rome, Italy
NOT_YET_RECRUITINGMaastricht University Medical Center
Maastricht, Netherlands
NOT_YET_RECRUITINGZeromski hospital
Krakow, Poland
NOT_YET_RECRUITINGDepartment of Orthopaedics, University of Gothenburg (UGOT)
Mölndal, Sweden
NOT_YET_RECRUITINGUniversity Hospital Basel
Basel, Switzerland
RECRUITING...and 1 more locations
Knee Injury and Osteoarthritis Outcome Score (KOOS)-5
Difference in 2-year change (baseline to 24 month follow-up) in the KOOS -5 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)
Time frame: 24 months
Knee Injury and Osteoarthritis Outcome questionnaire
patient self reported questionnaire for pain
Time frame: until 24 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)
Time frame: Until 24 months
Kujala questionnaire
patient self reported questionnaire for Anterior Knee Pain scale. Minimum score: 0 Maximum score: 100 (no knee problems)
Time frame: 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)
Time frame: Until 24 months
EQ-5D-5L questionnaire
Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems.
Time frame: 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.
Time frame: 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.
Time frame: Until 24 months
Morphological analysis
Morphological analysis with assessment of whole cartilage volume (in mm3) by radiological assessment (MRI)
Time frame: Until 24 months
Collagen network organization
Collagen network organization with T2 mapping and RADIOMICS GLCM by radiological assessment (MRI)
Time frame: Until 24 months
Osteoarthritis grading
Osteoarthritis grade according to Iwano and Kellgren/Lawrence classification by radiological assessment (X-ray)
Time frame: Until 24 months
Biovigilance
Number of adverse events, adverse reactions based on severity, expectedness and relationship to treatment.
Time frame: Until 24 months
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