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Treatment of osteoarthritis behind the kneecap with tissue engineered nasal cartilage in a randomized, controlled, multicenter clinical trial
EU CTIS ID: 2023-508640-21-00
What this study is testing
Mean KOOS Pain Change from baseline to 24 months between groups
- 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
- 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
- Minimum values for women: Haemoglobin 120g/l, Platelets 150G/l, INR<1.3
- Minimum values for men: Haemoglobin 140g/l, Platelets 150G/l, INR<1.3
You likely can't join if
- Prior surgical treatment of the target knee within 12 months (Note: prior diagnostic arthroscopy with debridement and lavage are acceptable within 12 months)
- 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 >1) or MRI or pain in the tibiofemoral joint (clinical examination)
- Excessive varus or valgus deformity (>5°)
- Symptomatic meniscus lesion, 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
- 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
- Minimum values for women: Haemoglobin 120g/l, Platelets 150G/l, INR<1.3
- Minimum values for men: Haemoglobin 140g/l, Platelets 150G/l, INR<1.3
- Non-surgical standard of care options except for PRP have been exhausted
- Prior surgical treatment of the target knee within 12 months (Note: prior diagnostic arthroscopy with debridement and lavage are acceptable within 12 months)
- 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 >1) or MRI or pain in the tibiofemoral joint (clinical examination)
- Excessive varus or valgus deformity (>5°)
- Symptomatic meniscus lesion, 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 with any active infections
- patients on anticoagulants whose anticoagulant therapy cannot be interrupted as appropriate to the given agent(s) and underlying condition
- patients with increased bleeding risk (e.g. coagulopathies)
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. 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.