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

NCT05584553 | Completed Results FDA Device

• 1 other identifier: MDRG2017-89MS-70SM
• Study Type: observational
• Target: 214
• Locations: 2 countries
• Sites: 3

Brief 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

Keywords

Post-Market Clinical Follow-Up Study; Medical Device; Performance; Safety; Clinical Benefits

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Evidence of 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 an assessment of pain. Healing was assessed by clinical examination at a minimum of 12 months post-operation. Soft tissue-to-bone healing was evaluated through clinical assessment at follow-up. Healing was defined as restoration of tendon attachment to bone without visible gap, pain, or functional limitation. Clinical evaluation included absence of pain on palpation and a satisfactory range of motion. Results represent the number of participants meeting these criteria for complete healing.

  From operation to the study completion, minimum 1 year post-op. Through last available follow-up (mean = 2.1 years, range = 1.0-5.2 years for JuggerLoc; mean = 3.5 years, range = 1.0-7.0 years for ToggleLoc)

Secondary Outcomes (3)

• Number of Participants With Revision Surgery

  From date of surgery to last available follow-up (mean follow-up = 2.1 ± 1.1 years for JuggerLoc and 3.5 ± 2.0 years for ToggleLoc), minimum 1 year post-op.

• EuroQol Five-dimensional Health Questionnaire (EQ-5D-5L)

  From pre-operative baseline to last available follow-up (mean follow-up = 2.1 ± 1.1 years for JuggerLoc and 3.5 ± 2.0 years for ToggleLoc). Minimum 1 year post-operative

• Oxford Shoulder Score (OSS)

  From pre-operative baseline to last available follow-up (mean follow-up = 2.1 ± 1.1 years for JuggerLoc and 3.5 ± 2.0 years for ToggleLoc), minimum 1 year post-op.

Study Arms (2)

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

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

Interventions

ToggleLoc 2.9 mm soft tissue device 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.

ToggleLoc 2.9 mm soft tissue device

JuggerLoc soft tissue device 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.

JuggerLoc soft tissue device

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Zimmer Biomet: lead

Study Sites (3)

Advanced Bone and Joint

City of Saint Peters, Missouri, 63376, United States

Location

Centro Médico Quirónsalud

Alicante, 03184, Spain

Location

Hospital Universitario Quirónsalud

Madrid, 28223, Spain

Location

MeSH Terms

Conditions

Bankart Lesions; Joint Dislocations

Condition Hierarchy (Ancestors)

Shoulder Fractures; Fractures, Bone; Wounds and Injuries; Shoulder Injuries; Joint Diseases; Musculoskeletal Diseases

Limitations and Caveats

The retrospective setting of the study

Results Point of Contact

• Title: Dr Nesma Bayrich
• Organization: Zimmer Biomet

nesma.bayrich@zimmerbiomet.com

+41793001484

Study Officials

• Hassan ACHAKRI

  Zimmer Biomet

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 25, 2022
• First Posted: October 18, 2022
• Study Start: December 2, 2022
• Primary Completion: June 30, 2024
• Study Completion: June 30, 2024
• Last Updated: November 28, 2025
• Results First Posted: November 28, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

ES (2); US (1)