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

Biceps Tendon Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05584553
• Other study ID #: MDRG2017-89MS-70SM
• Status: Enrolling by invitation
• Start date: December 2, 2022
• Est. completion date: June 30, 2024

Study information

• Verified date: April 2023
• Source: Zimmer Biomet
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

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 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).

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 206
• Est. completion date: June 30, 2024
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Bankart Lesions
• Biceps Tendon Disorder
• Capsular Shift/Capsulolabral Reconstruction
• Deltoid Repair
• Rotator Cuff Injuries
• Rotator Cuff Tear Repair
• SLAP Lesion
• Tendinopathy

Intervention

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
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.

Locations

Country	Name	City	State
Spain	Centro Médico Quirónsalud	Alicante
Spain	Hospital Universitario Quirónsalud	Madrid
United States	Advanced Bone and Joint	Saint Peters	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Zimmer Biomet

Countries where clinical trial is conducted

United States,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Soft tissue to bone healing in the shoulder	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	Incidence of revisions	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.
Secondary	EuroQol five-dimensional Health Questionnaire (EQ-5D-5L)	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.
Secondary	Oxford Shoulder Score (OSS)	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.