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Epicondylitis of the Elbow clinical trials

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NCT ID: NCT05519228 Active, not recruiting - Clinical trials for Epicondylitis of the Elbow

PMCF Study on the Safety, Performance and Clinical Benefits Data of the ToggleLoc™ 2.9mm in the Elbow

Start date: September 12, 2022
Phase:
Study type: Observational

The study is a multicenter, retrospective, non-randomized, non-controlled and consecutive series post-market study. The purpose of this study is to collect data confirming safety, performance and clinical benefits of the ToggleLoc 2.9 mm Soft Tissue System when used for soft tissue to bone fixation in the elbow. The primary objective is the assessment of performance by analyzing soft tissue to bone healing in the elbow. The secondary objective is the assessment of safety and clinical benefits. Safety will be evaluated by recording and analyzing the incidence and frequency of complications and adverse events. Relation of the events to device, instrumentation and/or procedure will be specified. Clinical benefits will be assessed by recording patient-reported outcome measures (PROMs) at the longest follow-up after surgery (minimum one year).