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

NCT05584553 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 214

Last updated 2025-11-28

Study results available
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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 and the JuggerLoc Soft Tissue Systems when used for soft tissue to bone fixation in the shoulder.

The primary objective is the assessment of performance by analyzing soft tissue to bone healing in the shoulder.

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).

Conditions

  • Bankart Lesions
  • SLAP Lesion
  • Acromioclavicular; Dislocation
  • Capsular Shift/Capsulolabral Reconstruction
  • Deltoid Repair
  • Rotator Cuff Tear Repair
  • Biceps Tendon Disorder

Interventions

DEVICE

ToggleLoc 2.9 mm soft tissue device

The ToggleLoc 2.9 mm Soft Tissue devices consist of non-resorbable devices intended to aid in arthroscopic and orthopaedic reconstructive procedures requiring soft tissue to bone fixation.

DEVICE

JuggerLoc soft tissue device

The JuggerLoc Soft Tissue devices consist of non-resorbable devices intended to aid in arthroscopic and orthopaedic reconstructive procedures requiring soft tissue to bone fixation.

Sponsors & Collaborators

  • Zimmer Biomet

    lead INDUSTRY

Principal Investigators

  • Hassan ACHAKRI · Zimmer Biomet

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-12-02
Primary Completion
2024-06-30
Completion
2024-06-30
FDA Device
Yes

Countries

  • United States
  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05584553 on ClinicalTrials.gov