N-TEC for Patellofemoral osteoarthritis | Knee osteoarthritis

Inclusion criteria

• {"criterion_text":"- Patient age is ≥18 and ≤ 70 years at time of screening"}
• {"criterion_text":"- Symptomatic PFOA grade 1-4 according to Iwano Classification"}
• {"criterion_text":"- Chondropathy Grade 3-4 according to ICRS classification of the patella, trochlea femoris or both"}
• {"criterion_text":"- Baseline score of <75 on the KOOS-5 subjective knee evaluation"}
• {"criterion_text":"- Free range of motion of the affected knee joint or ≤ 5° of extension loss and minimum 125° flexion"}
• {"criterion_text":"- Patient is willing and able to give written informed consent"}

Exclusion criteria

• {"criterion_text":"- 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"}
• {"criterion_text":"- Patient is pregnant, breast feeding or anticipates becoming pregnant within 24 months after surgery"}
• {"criterion_text":"- 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"}
• {"criterion_text":"- Patient is unwilling, unable or lacking the capacity to provide informed consent"}
• {"criterion_text":"- Patient has known current or recent history of illicit drug or alcohol"}
• {"criterion_text":"- Any known allergies, especially for porcine collagen, penicillin or streptomycin"}
• {"criterion_text":"- Patient is unable to undergo magnetic resonance imaging (MRI)"}
• {"criterion_text":"- Prior surgical treatment of the target knee within 12 months"}
• {"criterion_text":"- 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"}
• {"criterion_text":"- Patient has excessive varus or valgus deformity (>5°), unless corrected during implantation"}
• {"criterion_text":"- Nail Patella syndrome"}
• {"criterion_text":"- Patient has a symptomatic meniscus lesion (or removal exceeding ½), as indicated by clinical examination (joint line tenderness and McMurray test positive) and MRI."}
• {"criterion_text":"- Patient has a body mass index (BMI) >35 kg/m2"}
• {"criterion_text":"- Patient has chronic rheumatoid arthritis, and/or infectious arthritis"}
• {"criterion_text":"- Patients who will likely benefit from conservative therapy, such as physiotherapy, medical training therapy and pain medication"}
• {"criterion_text":"- Any concomitant painful or disabling disease of the spine, hips, or lower limbs that would interfere with evaluation of the afflicted knee"}
• {"criterion_text":"- Patient has a known immunological suppressive disorder or is taking immunosuppressives"}
• {"criterion_text":"- Patient had any intra-articular injections into the affected knee within the last 3 months before baseline visit"}
• {"criterion_text":"- Instability of anterior, posterior and/or collateral ligaments"}
• {"criterion_text":"- The patient has a HIV/AIDS infection"}
• {"criterion_text":"- The patient has an acute Treponema pallidum (syphilis) infection"}
• {"criterion_text":"- 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"}
• {"criterion_text":"- Patients with increased anesthesiological and surgical risks"}
• {"criterion_text":"- Patients with increased bleeding risk (e.g. coagulopathies)"}
• {"criterion_text":"- Patients on anticoagulants whose anticoagulant therapy cannot be interrupted as appropriate to the given agent(s) and underlying condition"}
• {"criterion_text":"- Patients with any active infections"}
• {"criterion_text":"- Patient has any other condition, which, in the opinion of the investigator, would make the patient unsuitable for the study"}

Primary endpoints

• {"endpoint_text":"- Change in KOOS-5 subjective score from baseline to the 24-month follow-up","definition_or_measurement_approach":"Change in KOOS-5 (subjective knee evaluation) from baseline to 24 months as measured by the KOOS-5 questionnaire."}

Secondary endpoints

• {"endpoint_text":"- Mean KOOS subscores at all timepoints (baseline, 6, 12 and 24 months)","definition_or_measurement_approach":"Mean KOOS subscores measured at baseline, 6, 12 and 24 months."}
• {"endpoint_text":"- Kujala Anterior Knee Pain Scale at 6, 12 and 24 months","definition_or_measurement_approach":"Kujala score assessed at 6, 12 and 24 months."}
• {"endpoint_text":"- WOMAC Score at baseline, 6, 12 and 24 months","definition_or_measurement_approach":"WOMAC assessed at baseline, 6, 12 and 24 months."}
• {"endpoint_text":"- EQ-5D-5L at baseline 6, 12 and 24 months","definition_or_measurement_approach":"EQ-5D-5L assessed at baseline, 6, 12 and 24 months."}
• {"endpoint_text":"- GROC likert scale at baseline, 6, 12 and 24 months","definition_or_measurement_approach":"GROC Likert scale measured at baseline, 6, 12 and 24 months."}
• {"endpoint_text":"- Marx Activity Rating Scale at baseline, 6, 12 and 24 months","definition_or_measurement_approach":"Marx Activity Rating Scale assessed at baseline, 6, 12 and 24 months."}
• {"endpoint_text":"- VAS Score at baseline, 6, 12 and 24 months","definition_or_measurement_approach":"Visual Analog Scale (VAS) for pain measured at baseline, 6, 12 and 24 months."}
• {"endpoint_text":"- Patient Satisfaction Questionnaire at 24 months","definition_or_measurement_approach":"Patient satisfaction assessed by questionnaire at 24 months."}
• {"endpoint_text":"- MRI at baseline, 6, 12 and 24 months","definition_or_measurement_approach":"MRI imaging performed at baseline, 6, 12 and 24 months to assess graft integration and repair tissue maturation."}
• {"endpoint_text":"- X-ray at baseline, 6, 12 and 24 months","definition_or_measurement_approach":"X-ray imaging at baseline, 6, 12 and 24 months to assess structural changes."}
• {"endpoint_text":"- Safety (number of SARs and SUSARs)","definition_or_measurement_approach":"Safety evaluated based on the number of SARs and SUSARs reported."}
• {"endpoint_text":"- Number of treatment failures at 24 months","definition_or_measurement_approach":"Count of treatment failures assessed at 24 months."}

Austria

Earliest CTIS Part Ii Submission Date

30-04-2025

Latest Decision Or Authorization Date

11-06-2025

Processing Time Days

42

Number Of Sites

1

Number Of Participants

13

Croatia

Earliest CTIS Part Ii Submission Date

15-05-2025

Latest Decision Or Authorization Date

13-06-2025

Processing Time Days

29

Number Of Sites

1

Number Of Participants

14

Italy

Earliest CTIS Part Ii Submission Date

12-03-2025

Latest Decision Or Authorization Date

13-06-2025

Processing Time Days

93

Number Of Sites

2

Number Of Participants

28

Sweden

Earliest CTIS Part Ii Submission Date

12-03-2025

Latest Decision Or Authorization Date

10-06-2025

Processing Time Days

90

Number Of Sites

1

Number Of Participants

13

Poland

Earliest CTIS Part Ii Submission Date

21-05-2025

Latest Decision Or Authorization Date

16-06-2025

Processing Time Days

26

Number Of Sites

1

Number Of Participants

13

Germany

Earliest CTIS Part Ii Submission Date

22-05-2025

Latest Decision Or Authorization Date

13-06-2025

Processing Time Days

22

Number Of Sites

2

Number Of Participants

28

Netherlands

Earliest CTIS Part Ii Submission Date

12-05-2025

Latest Decision Or Authorization Date

16-06-2025

Processing Time Days

35

Number Of Sites

1

Number Of Participants

13

Primary sponsor

Full Name

Universitaetsspital Basel

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Switzerland

Third parties

• {"country":"","full_name":"European Commission (Horizon Europe)","duties_or_roles":"Monetary support / funding","organisation_type":""}