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Идёт набор NCT06681051

Effectiveness and Safety of OSTENIL® TENDON in the Treatment of Pain and Restricted Mobility in Tendon Disorders

— Наблюдательное Tendinopathy

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: OSTENIL® TENDON.
Кому может быть актуально
Состояния в реестре: Tendinopathy. Базовые параметры: 18 лет — 99 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Германия
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Обзор

PMCF study to further substantiate the effectiveness and safety of OSTENIL® TENDON in the overall as well as indication-specific treatment of pain and restricted mobility in four different tendon disorders (patella tendon, peroneal tendon, medial epicondylus humeri and iliotibial band) in a real-life clinical setting when used according to the instructions for use.

Вмешательства

  • Устройство OSTENIL® TENDON
    OSTENIL® TENDON is a CE-certified viscoelastic solution intended for peritendinous or intrasheath injection, containing 2 % sodium hyaluronate from fermentation.

Первичные конечные точки

  • Change of pain intensity 3 months after end of treatment compared to baseline (visual analogue scale) [Срок оценки: Baseline compared to week 12 after the end of treatment.]
Вторичные конечные точки (9)
  • Change of Upper -/ Lower Extremity Functional Scale compared to baseline [Срок оценки: Baseline compared to week 1 as well as weeks 4, 12 and 24 after the end of treatment.]
  • Change of pain intensity compared to baseline (visual analogue scale) [Срок оценки: Baseline compared to week 1 as well as weeks 4 and 24 after the end of treatment.]
  • Change of patient-reported outcome measures (PROM) [Срок оценки: Baseline (except satifaction with treatment), week 1 and weeks 4, 12 and 24 after the end of treatment.]
  • Change of investigator-reported outcome measures [Срок оценки: Baseline (except satisfaction with treatment), week 1 and weeks 4, 12 and 24 after the end of treatment.]
  • Degree of tendinopathy [Срок оценки: Baseline, week 1 and weeks 4, 12 and 24 after the end of treatment]
  • Incidence of Adverse Events with (possible/probable) causal relationship with the device or application procedure [Срок оценки: Up to week 24 after the end of treatment.]
  • Incidence of Serious Adverse Events with (possible/probable) causal relationship with the device or application procedure [Срок оценки: Up to week 24 after the end of treatment.]
  • Incidence of (Presumably) serious incidents [Срок оценки: Up to week 24 after the end of treatment.]
  • Incidence of Device Deficiencies [Срок оценки: Up to week 24 after the end of treatment.]

Критерии участия

Критерии включения

  • Patient aged between 18 and 99 years
  • Diagnosis of symptomatic tendinopathy (patella tendon, peroneal tendon, medial epicondylus humeri or iliotibial band)
  • Physician's recommendation to use OSTENIL® TENDON prior to recruitment
  • Signed informed consent

Критерии исключения

  • Presence of any contra-indication or precautionary condition listed in the instructions for use, i.e.,
  • Ascertained hypersensitivity to any of the OSTENIL® TENDON constituents
  • Known pregnancy or breast feeding
  • Acute trauma
  • Use of the following treatments (the given time intervals refer to the date of inclusion):
  • Local\* OSTENIL® TENDON or other hyaluronic acid (HA) treatment within the last 6 months
  • Local\* platelet-rich plasma (PRP) treatment within the last 3 months
  • Local\* corticosteroid treatment (without time restriction)
  • Local\* extracorporeal shock wave therapy (ESWT) within the last 4 weeks
  • Local\* phytotherapy (e.g., Traumeel®) within the last 4 weeks
  • Local\* surgical intervention (without time restriction)
  • Systemic corticosteroid treatment within the last 4 weeks
  • Repeated use of non-steroidal anti-inflammatory drugs (NSAID) and/or other analgesics within the last week
  • Physiotherapy (therapeutic exercises and physical therapy), ortheses, transcutaneous electrical nerve stimulation (TENS) or acupuncture within the last week
  • Diagnosis of chronic inflammatory disease (e.g. rheumatoid arthritis, Bechterew disease, Crohn's disease, etc.) prior to inclusion
  • Participation in a clinical investigation within the last 6 months
  • Vulnerable patient (individual who is unable to fully understand all aspects of the study that are relevant to the decision to participate, or who could be manipulated or unduly influenced as a result of a compromised position, expectation of benefits or fear of retaliatory response \[including persons needing legally designated representatives, illiterate persons or persons with insufficient knowledge of local language\])

(\* local refers to the treatment of the study-relevant tendon)

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Только случаи

Центры проведения

Германия · 5 центров
  • Orthopädische Gemeinschaftspraxis ÜBAG — Berlin
  • ATOS MVZ meviva Berlin — Berlin
  • Orthopädie am Kiesteich — Berlin
  • Orthopädie Dr. Bentzin — Berlin
  • Orthopädische Praxis Dr. Fischer — Potsdam

Идентификаторы

NCT: NCT06681051 · OTIPPE-PMCF-DE-2021

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗