NCT05519228

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

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: Completed
• Phase: —
• Study type: Observational
• Enrollment: 83 (actual)
• Sponsor: Zimmer Biomet · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Detailed 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.

Conditions

• Epicondylitis of the Elbow
• Biceps Tendon Disorder

Interventions

Type	Name	Description
DEVICE	ToggleLoc 2.9 mm Soft Tissue System	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

Timeline

• Start date: 2022-09-12
• Primary completion: 2023-09-27
• Completion: 2024-02-20
• First posted: 2022-08-29
• Last updated: 2025-01-30
• Results posted: 2024-11-12

Locations

2 sites across 2 countries: United States, Spain

Regulatory

• FDA-regulated device study