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

Epicondylitis of the Elbow Clinical Trial

Official title: Post-market Clinical Follow-up Study to Provide Safety, Performance and Clinical Benefits Data of the ToggleLoc™ 2.9mm Soft Tissue System (Implants and Instrumentation) in the Elbow - A Multicenter Retrospective Consecutive Study

Status Active, not recruiting

Clinical Trial Summary

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).

Clinical Trial Description

The ToggleLoc 2.9 mm Soft Tissue System consist of non-resorbable device intended to aid in arthroscopic and orthopaedic reconstructive procedures requiring soft tissue to bone fixation. The clinical purpose is to restore the function and flexibility of the elbow requiring soft tissue to bone fixation and to relieve pain that cannot be controlled by other treatments.

Two sites will be involved in this study. The aim is to include a total of 83 consecutive series cases operated with the ToggleLoc 2.9 mm in the elbow. All potential study subjects will be required to participate in the Informed Consent Process.

Baseline data from the preop and intraop will be available in medical notes. The patients will be asked to complete patient questionnaires during a minimum 1 year follow up visit/phone call. In addition, any complications and adverse events that occured since the surgery will also be collected during the follow-up visit/phone call. ;

Related Conditions & MeSH terms

• Biceps Tendon Disorder
• Epicondylitis of the Elbow
• Tendinopathy

• NCT number: NCT05519228
• Study type: Observational
• Source: Zimmer Biomet
• Status: Active, not recruiting
• Start date: September 12, 2022
• Completion date: February 2024