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Идёт набор NCT06948591

BioBrace® Augmentation in Anterior Cruciate Ligament Reconstruction Procedures

— Наблюдательное ACL Tears

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: Anterior cruciate ligament reconstruction with BioBrace® augmentation, Arthroscopic anterior cruciate ligament reconstruction.
Кому может быть актуально
Состояния в реестре: ACL Tears. Базовые параметры: 14 лет — 70 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
США
Следующий шаг
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Официальное название

Real World Evaluation of the Safety and Effectiveness of BioBrace® Augmentation in Anterior Cruciate Ligament (ACL) Reconstruction Procedures

Обзор

This research study will evaluate mid-term clinical safety and performance outcomes of the BioBrace® Reinforced Implant when used to augment a tissue graft during anterior cruciate ligament (ACL) reconstruction.

Подробное описание

This is a multi-center, single arm, open label registry investigating anterior cruciate ligament reconstruction (ACLR) procedures where the tissue graft is augmented with BioBrace®. Subjects meeting the inclusion/exclusion criteria will be enrolled retrospectively or prospectively. Clinical evaluations will be conducted at baseline (pre-operatively) and at 6 months, 1-, 2-, and 3-years post-operatively using various patient-reported outcome measures to assess pain, function, return to activity, and safety post-surgery.

Вмешательства

  • Устройство Anterior cruciate ligament reconstruction with BioBrace® augmentation
    An arthroscopic anterior cruciate ligament reconstruction (ACLR) will be performed and the tissue graft will be augmented with the BioBrace® Reinforced Implant. BioBrace® is intended for use in surgical procedures for reinforcement of soft tissue where weakness exists. It is a bioresorbable, biocomposite scaffold composed of a highly porous collagen sponge and reinforced with poly-L-lactic-acid (PLLA). When used in ACLRs, it is sutured alongside the tissue graft to augment and reinforce the graf
  • Процедура Arthroscopic anterior cruciate ligament reconstruction
    An arthroscopic anterior cruciate ligament reconstruction is performed using standard surgical procedure.

Первичные конечные точки

  • Improvement in Function [Срок оценки: 3 years post-op]
  • Adverse Events [Срок оценки: Baseline, 6-months, 1-, 2-, and 3-years post-op]
Вторичные конечные точки (7)
  • International Knee Documentation Committee (IKDC) [Срок оценки: Baseline, 6 months, 1-, 2-years post-op]
  • Knee Injury and Osteoarthritis Outcome Score Junior (KOOS, JR.) [Срок оценки: Baseline, 6 months, 1-, 2-, and 3-years post-op]
  • Patient-Reported Outcomes Measurement Information System (PROMIS-10) [Срок оценки: Baseline, 6 months, 1-, 2-, and 3-years post-op]
  • Tegner Activity Scale (TAS) [Срок оценки: Baseline, 6 months, 1-, 2-, and 3-years post-op]
  • Anterior Cruciate Ligament - Return to Sport After Injury (ACL-RSI) [Срок оценки: 6 months, 1-, 2-, and 3-years post-op]
  • Secondary Surgical Intervention(s) [Срок оценки: 6 months, 1-, 2-, and 3-years post-op]
  • Re-tear Rate [Срок оценки: 6 months, 1-, 2-, and 3-years post-op]

Критерии участия

Критерии включения

  • Underwent ACL reconstruction with a tissue graft augmented with BioBrace® within the past 24 months from study start date or scheduled to undergo ACL reconstruction with a tissue graft augmented with BioBrace®.
  • Between 14 and 70 years old at the time of surgery.
  • Can understand the content of the subject information / Informed Consent Form (ICF) for the prospective portion of the study.
  • Is willing and able to participate in the prospective data collection protocol and comply with the required data collection.
  • If the subject has already undergone ACLR within the past 24 months, subject must have at least two (2) of the following measures at baseline and 1 year post-operatively:
  • International Knee Documentation Committee (IKDC)
  • Knee Injury and Osteoarthritis Outcome Score Junior (KOOS, JR.)
  • Patient-Reported Outcomes Measurement Information System (PROMIS-10)
  • Tegner Activity Scale (TAS)
  • Anterior Cruciate Ligament - Return to Sport After Injury (ACL-RSI)
  • Positive diagnostic imaging by MRI at baseline indicating an ACL tear

Критерии исключения

  • Has other concurrent medical or other conditions (chronic or acute in nature) that in the opinion of the participating investigator may prevent participation or otherwise render subject ineligible for the study.
  • Is currently participating in an investigational therapy (device and/or pharmaceutical) within 30 days prior to entering the study or such treatment is planned during the 3 years following enrollment into the study.
  • Underwent or scheduled to undergo a multi-ligament reconstruction procedure (excluding cases where a torn MCL is treated non-operatively).
  • Females of child-bearing potential who are either pregnant or breastfeeding at the time of surgery.

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

Дизайн исследования

Модель наблюдения
Только случаи

Центры проведения

США · 1 центр
  • ConMed — New Haven

Идентификаторы

NCT: NCT06948591 · CSP-BB0004

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗