N-TEC for Patellofemoral osteoarthritis | Knee osteoarthritis

Inclusion criteria

• {"criterion_text":"-Symptomatic PFOA grade 1-3 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 <60 on the KOOS Pain 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":"-Minimum values for women: Haemoglobin 120g/l, Platelets 150G/l, INR<1.3"}
• {"criterion_text":"-Minimum values for men: Haemoglobin 140g/l, Platelets 150G/l, INR<1.3"}
• {"criterion_text":"-Non-surgical standard of care options except for PRP have been exhausted"}

Exclusion criteria

• {"criterion_text":"-Prior surgical treatment of the target knee within 12 months (Note: prior diagnostic arthroscopy with debridement and lavage are acceptable within 12 months)"}
• {"criterion_text":"-patients with increased anesthesiological and surgical risks (e.g. known or predicted difficult airway, myocardial infarction <60 days prior to surgery)"}
• {"criterion_text":"-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)"}
• {"criterion_text":"-Excessive varus or valgus deformity (>5°)"}
• {"criterion_text":"-Symptomatic meniscus lesion, 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 with any active infections"}
• {"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 increased bleeding risk (e.g. coagulopathies)"}

Primary endpoints

• {"endpoint_text":"-Comparison of mean change in KOOS Pain from baseline to 24 months between groups (N-TEC – PRP > 15)","definition_or_measurement_approach":"Mean KOOS Pain change from baseline to 24 months between groups; KOOS Pain score measured at baseline and 24 months."}

Secondary endpoints

• {"endpoint_text":"-Mean KOOS Pain at 6 and 12 months","definition_or_measurement_approach":"KOOS Pain score measured at 6 and 12 months."}
• {"endpoint_text":"-Mean KOOS subscales (Symptoms, Activity of daily living (ADL), Sports & Recreation (Sports), Quality of Life (QOL)) at 6, 12 and 24 months","definition_or_measurement_approach":"KOOS subscale scores (Symptoms, ADL, Sports & Recreation, QOL) measured at 6, 12 and 24 months."}
• {"endpoint_text":"-Kujala Anterior Knee Pain Scale at 6, 12 and 24 months","definition_or_measurement_approach":"Kujala Anterior Knee Pain Scale assessed at 6, 12 and 24 months."}
• {"endpoint_text":"-WOMAC Score at 6, 12 and 24 months","definition_or_measurement_approach":"WOMAC questionnaire score measured at 6, 12 and 24 months."}
• {"endpoint_text":"-EQ-5D-5L at 6, 12 and 24 months","definition_or_measurement_approach":"EQ-5D-5L health-related quality of life instrument measured at 6, 12 and 24 months."}
• {"endpoint_text":"-VAS at 6, 12 and 24 months","definition_or_measurement_approach":"Visual analogue scale (pain) measured at 6, 12 and 24 months."}
• {"endpoint_text":"-Number of treatment failures and subjects non-responding (improvement in KOOS Pain < 13 on a scale of 0-100) at 24 months","definition_or_measurement_approach":"Count of subjects with KOOS Pain improvement <13 at 24 months (non-responders) and number of treatment failures."}
• {"endpoint_text":"-Global Rating Of Change (GROC) likert scale at 6, 12 and 24 months","definition_or_measurement_approach":"GROC Likert scale ratings at 6, 12 and 24 months."}
• {"endpoint_text":"-MARS at 6, 12 and 24 months","definition_or_measurement_approach":"Marx Activity Rating Scale assessed at 6, 12 and 24 months."}
• {"endpoint_text":"-MRI Osteoarthritis Knee Score (MOAKS) for radiological evaluation of osteoarthritis at 6, 12 and 24 months","definition_or_measurement_approach":"MOAKS radiological scoring of osteoarthritis on MRI at 6, 12 and 24 months."}
• {"endpoint_text":"-MRI of Cartilage Repair Tissue (MOCART) for radiological evaluation of repair tissue at 6, 12 and 24 months","definition_or_measurement_approach":"MOCART scoring of cartilage repair tissue on MRI at 6, 12 and 24 months."}
• {"endpoint_text":"-Osteoarthritis grade according to Iwano and Kellgren/Lawrence classification at 6, 12 and 24 months","definition_or_measurement_approach":"Radiographic grading of osteoarthritis by Iwano and Kellgren/Lawrence classifications at 6, 12 and 24 months."}
• {"endpoint_text":"-Number of SARs and SUSARs to assess safety","definition_or_measurement_approach":"Counting of serious adverse reactions (SARs) and suspected unexpected serious adverse reactions (SUSARs) to evaluate safety."}

Methods

• Recruitment via study homepage (K2_Recruitment material_Homepage_EN / DE / FR / IT documents)
• Local site recruitment through participating orthopaedic clinics in Germany and Croatia (site contact details provided in trial record)
• Recruitment arrangements documented in K1_Recruitment arrangements (public document)

Germany

Earliest CTIS Part Ii Submission Date

16-09-2024

Latest Decision Or Authorization Date

29-08-2025

Processing Time Days

347

Number Of Sites

2

Number Of Participants

16

Croatia

Earliest CTIS Part Ii Submission Date

06-02-2025

Latest Decision Or Authorization Date

30-01-2026

Processing Time Days

358

Number Of Sites

2

Number Of Participants

14

Primary sponsor

Full Name

Universitaetsspital Basel

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Switzerland

Third parties

• {"country":"Switzerland","full_name":"Swiss national science foundation","duties_or_roles":"Monetary support / funding","organisation_type":"Funding organisation"}