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

December 13, 2023 updated by: Zimmer Biomet

Post-market Clinical Follow-up Study to Provide Safety, Performance and Clinical Benefits Data of the ToggleLoc™ 2.9mm and the JuggerLoc™ Soft Tissue Systems (Implants and Instrumentation) in the Shoulder - A Multicenter Retrospective Study

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).

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Detailed Description

The ToggleLoc 2.9 mm and JuggerLoc Soft Tissue devices consist of non-resorbable devices 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 shoulder requiring soft tissue to bone fixation and to relieve pain that cannot be controlled by other treatments.

Three sites will be involved in this study. The aim is to include a total of 206 (103 cases operated with the ToggleLoc 2.9 mm and 103 cases operated with the JuggerLoc in the shoulder) consecutive series cases. 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.

Study Type

Observational

Enrollment (Estimated)

206

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Spain
      • Alicante, Spain, 03184
        • Centro Médico Quirónsalud
      • Madrid, Spain, 28223
        • Hospital Universitario Quirónsalud
  • United States
    • Missouri
      • Saint Peters, Missouri, United States, 63376
        • Advanced Bone and Joint

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients who had required a soft tissue to bone fixation in the shoulder with the ToggleLoc 2.9 mm and/or the JuggerLoc Soft Tissue devices according to Zimmer Biomet's Instruction for Use (IFU) and and who meet all the inclusions criteria and none of the exclusions criteria.

Description

Inclusion Criteria:

  • Patients that received the ToggleLoc 2.9 mm and/or the JuggerLoc Soft Tissue devices for soft tissue to bone fixation in the shoulder.
  • Patients 18 years or older and skeletally mature.
  • Patients capable of understanding the surgeon's explanations and following his/her instructions, able and willing to participate in the follow-up program and who gave consent to take part in the study.

Exclusion Criteria:

  • Infection.
  • Patient conditions including blood supply limitations, and insufficient quantity or quality of bone or soft tissue.
  • Patients with mental or neurologic conditions who are unwilling or incapable of following postoperative care instructions.
  • Foreign body sensitivity. Where material sensitivity is suspected, testing is to be completed prior to implantation of the device.
  • Patients who are unwilling or unable to give consent, or to comply with the follow-up program.
  • Patients who have any condition that would in the judgment of the Investigator place the patient at undue risk or interfere with the study.
  • Patient is a vulnerable subject (prisoner, mentally incompetent or unable to understand what participation to the study entails, a known alcohol or drug abuser, anticipated to be non-compliant).
  • Off-label use.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
ToggleLoc 2.9 mm soft tissue device
Patients who already received the ToggleLoc 2.9 mm soft tissue device in the shoulder. No additional surgery will be performed.
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.
JuggerLoc soft tissue device
Patients who already received the JuggerLoc soft tissue device in the shoulder. No additional surgery will be performed.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Soft tissue to bone healing in the shoulder
Time Frame: From operation to the study completion, minimum 1 year post-op.
Assessment of performance by analyzing soft tissue to bone healing in the shoulder. The principal investigator will clinically evaluate the study shoulder to assess if soft tissue to bone healing has occurred using a assessment of pain. Pain will be measured from none (no pain) to severe.
From operation to the study completion, minimum 1 year post-op.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of revisions
Time Frame: From operation to the study completion, minimum 1 year post-op.
Safety will be evaluated by recording and analyzing the incidence of revisions. A Kaplan Meier survival curve will be calculated. The Kaplan-Meier involves computing of probabilities of occurrence of revision at a certain point of time.
From operation to the study completion, minimum 1 year post-op.
EuroQol five-dimensional Health Questionnaire (EQ-5D-5L)
Time Frame: From pre-operative to the study completion, minimum 1 year post-op.
Clinical benefits will be assessed by recording patient-reported outcome measures (PROMs). The EuroQol five-dimensional Health Questionnaire (EQ-5D-5L): is a generic instrument. The EQ is scored on a 0 to 100 mm scale representing "the worst..." and "the best health you can imagine", respectively.
From pre-operative to the study completion, minimum 1 year post-op.
Oxford Shoulder Score (OSS)
Time Frame: From pre-operative to the study completion, minimum 1 year post-op.
Clinical benefits will be assessed by recording patient-reported outcome measures (PROMs). the Oxford Shoulder Score (OSS) is a 12-item, each with 5 potential answers specifically designed and developed for assessing outcomes of shoulder surgery. The score will be on a scale from 0 (worst) to 48 (best).
From pre-operative to the study completion, minimum 1 year post-op.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Zimmer Biomet

Investigators

  • Study Director: Hassan Achakri, Zimmer Biomet

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 2, 2022

Primary Completion (Estimated)

June 30, 2024

Study Completion (Estimated)

June 30, 2024

Study Registration Dates

First Submitted

April 25, 2022

First Submitted That Met QC Criteria

October 17, 2022

First Posted (Actual)

October 18, 2022

Study Record Updates

Last Update Posted (Estimated)

December 14, 2023

Last Update Submitted That Met QC Criteria

December 13, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MDRG2017-89MS-70SM

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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