PMCF Study on the Safety, Performance and Clinical Benefits Data of the ComposiTCP

Официальное название

Post-market Clinical Follow-up Study to Collect Safety, Performance and Clinical Benefits of the ComposiTCP™ Suture Anchors Double Loaded With BroadBand Tape, Sliding

Обзор

The study is a multicenter, retrospective and prospective, non-randomized, noncontrolled, and consecutive series post-market study. The purpose of this study is collect data confirming safety, performance and clinical benefits of the ComposiTCP Suture Anchors Double Loaded with BroadBand Tape, Sliding implants when used in rotator cuff repair. The primary endpoint of this study is the assessment of performance by analyzing soft tissue to bone healing in the shoulder (rotator cuff). Healing will be assessed by the investigator using PROMs and clinical outcomes of the patient. The clinical benefit will be assessed by functional outcomes measured using standard and well-established scoring systems (e.g. Oxford Shoulder Score and EQ-5D-5L) at 1 year post-operative. The safety will be assessed by monitoring the incidence and frequency of device- and/or procedure-related adverse events.

Подробное описание

The ComposiTCP Suture Anchors Double Loaded with BroadBand Tape, Sliding implants are intended for use in rotator cuff repairs. They are intended for for the reattachment of soft tissue to bone.

Up to two sites will be involved in this study. The aim is to include a total of 43 consecutive series cases who received the device. All potential study subjects will be required to participate in the Informed Consent Process.

Baseline data from the preop, intraop and immediate post-op intervals will be available in medical notes and collected retrospectively. During follow-up visits at 1 years post-op, the patient will be asked to complete patient questionnaires. Moreover, a clinical assessment will be conducted. In addition, any complications and adverse events will also be collected during these follow-up visits.

Первичные конечные точки

• Assessment of performance by analyzing soft tissue to bone healing in the shoulder (rotator cuff) [Срок оценки: From operation to study completion, 0-1 year]

Вторичные конечные точки (3)

• EQ-5D-5L Score [Срок оценки: From operation to study completion, 0-1 year]
• The incidence and frequency of device and/or procedure related adverse events [Срок оценки: From operation to study completion, 0-1 year]
• Oxford Shoulder Score [Срок оценки: From surgery until study completion, 0-1 year]

Критерии участия

Критерии включения

• Subject was treated with the ComposiTCP Suture Anchors Double Loaded with BroadBand Tape, Sliding for rotator cuff repair;
• At least 18 years old and skeletally mature;
• Willing and able to comply with the study procedures;
• Subject is capable of understanding the doctor's explanations, following his instructions and is able to participate in the follow-up program;
• Subject is able to read and understand the ICF and has voluntarily provided written informed consent or non-opposition.

Критерии исключения

• Subject is vulnerable (is unable to fully understand all aspects of the investigation 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);
• The subject is unwilling or unable to give consent or to comply with the follow-up program;
• Subject meets any contraindications of the appropriate Instruction for Use;
• Off-Label Use.

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

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Франция · 1 центр

• Clinique Mutualiste de Bretagne Occidentale — Quimper

Идентификаторы

NCT: NCT07080450 · MDRG2017-89MS-197SM

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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