2024-513683-25-00招募中2 期
Randomized, controlled, multi-center phase II clinical trial for the treatment of patellofemoral osteoarthritis with nasal chondrocyte-based tissue engineered cartilage implantation vs current standard of care (ENCANTO)
Universitaetsspital Basel9 个研究点 分布在 7 个国家目标入组 122 人开始时间: 2025年6月10日最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 122
- 试验地点
- 9
- 主要终点
- Change in KOOS-5 subjective score from baseline to the 24-month follow-up
研究概览
简要总结
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.
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Change in KOOS-5 subjective score from baseline to the 24-month follow-up
Change in KOOS-5 subjective score from baseline to the 24-month follow-up
次要结局
- Mean KOOS subscores at all timepoints (baseline, 6, 12 and 24 months)
- Kujala Anterior Knee Pain Scale at 6, 12 and 24 months
- WOMAC Score at baseline, 6, 12 and 24 months
- EQ-5D-5L at baseline 6, 12 and 24 months
- GROC likert scale at baseline, 6, 12 and 24 months
- Marx Activity Rating Scale at baseline, 6, 12 and 24 months
- VAS Score at baseline, 6, 12 and 24 months
- Patient Satisfaction Questionnaire at 24 months
- MRI at baseline, 6, 12 and 24 months
- X-ray at baseline, 6, 12 and 24 months
- Safety (number of SARs and SUSARs)
- Number of treatment failures at 24 months
研究者
Ivan Martin
Scientific
Universitaetsspital Basel
研究点 (9)
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