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Randomized, controlled, multi-center clinical trial for the treatment of osteoarthritis behind the kneecap with tissue engineered nasal cartilage implantation vs current standard of care (ENCANTO)
EU CTIS ID: 2024-513683-25-00
What this study is testing
This proposed phase II trial seeks to primarily define whether implantation of N-TEC will lead to a superior clinical outcome as determined by the change in KOOS-5 from baseline to 24 months than the comparator (AMIC). Data will be collected for N-TEC vs. PFA, but only minimal differences in change of KOOS-5 from baseline to 24 months between the N-TEC and the comparator are expected.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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, trochlea femoris or both
- Baseline score of <75 on the KOOS-5 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
You likely can't join if
- 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
- 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°), unless corrected during implantation
- Nail Patella syndrome
- 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
See the full eligibility 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, trochlea femoris or both
- Baseline score of <75 on the KOOS-5 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
- 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
- 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°), unless corrected during implantation
- Nail Patella syndrome
- 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
- Patients who will likely benefit from conservative therapy, such as physiotherapy, medical training therapy and pain medication
- 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
- Patient is pregnant, breast feeding or anticipates becoming pregnant within 24 months after surgery
- Instability of anterior, posterior and/or collateral ligaments
- The patient has a HIV/AIDS infection
- The patient has an acute Treponema pallidum (syphilis) infection
- 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 not excluded
- Patients with increased anesthesiological and surgical risks
- 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
- Patient is currently participating or has participated in any other clinical study involving the actually affected knee, within 3 months prior to the screening visit
- Patient is unwilling, unable or lacking the capacity to provide informed consent
- Patient has known current or recent history of illicit drug or alcohol
- 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
- Patient is unable to undergo magnetic resonance imaging (MRI)
- Prior surgical treatment of the target knee within 12 months
The study team makes the final eligibility decision.
Where it's taking place
- Switzerland
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Switzerland. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.