Bankart LesionsNCT05584553
PMCF Study on the Safety, Performance and Clinical Benefits Data of the ToggleLoc™ 2.9mm and JuggerLoc™ in the Shoulder
An observational study of Bankart Lesions and SLAP Lesion, run by Zimmer Biomet at 3 sites in 2 countries.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bankart Lesions, SLAP Lesion, Acromioclavicular; Dislocation
- What is being tested?
- ToggleLoc 2.9 mm soft tissue device and JuggerLoc soft tissue device
- Type of treatment
- Medical device
- How many people
- 214 participants
- Where
- 3 sitesin 2 countries
- Study dates
- 2 Dec 2022to 30 Jun 2024
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
Spain2 sites
Centro Médico Quirónsalud
Alicante, 03184
Hospital Universitario Quirónsalud
Madrid, 28223
United States1 site
Advanced Bone and Joint
City of Saint Peters, Missouri, 63376
About this study
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
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).
Read the 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.
- Conditions
- Bankart Lesions, SLAP Lesion, Acromioclavicular; Dislocation, Capsular Shift/Capsulolabral Reconstruction, Deltoid Repair, Rotator Cuff Tear Repair
- Being tested
- ToggleLoc 2.9 mm soft tissue device, JuggerLoc soft tissue device
- Keywords
- Post-Market Clinical Follow-Up Study, Medical Device, Performance, Safety, Clinical Benefits
- Medical subject headings
- Bankart Lesions, Joint Dislocations
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ToggleLoc 2.9 mm soft tissue deviceDevice
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 deviceDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: JuggerLoc soft tissue device |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Safety will be evaluated by recording and analyzing the incidence of revisions. A Kaplan-Meier survival curve will be calculated. Revisions were defined as any subsequent surgical intervention involving removal, replacement, or modification of the index implant. Data were analyzed descriptively and using Kaplan-Meier survival analysis to estimate the probability of remaining revision-free over time. Results represent the number of participants who underwent at least one revision during follow-up.
Measured: 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)
Clinical benefits will be assessed by recording patient-reported outcome measures (PROMs). This standardized instrument includes five dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression). The EQ-5D is a standardized instrument widely used to measure health status. It is a self-reported assessment about the patient's quality of life composed of two parts: a questionnaire and a visual analogue scale (VAS). The questionnaire includes 5 questions referring to mobility, self-care, daily activities, pain/discomfort, and anxiety/depression. Each question can be answered in five ways, indicating no, slight, moderate, severe problems or inability to complete the task. In the derived EQ-5D-5L score, the highest score is 1 and the lowest score is -0.573; negative numbers correspond to a self-assessed health state. The VAS is a vertical scale ranging from 100 ('The best health you can imagine') to 0 ('The worst health you can imagine').
Measured: 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)
Clinical benefits will be assessed by recording patient-reported outcome measures (PROMs). The Oxford Shoulder Score (OSS) is a patient-reported outcome questionnaire that was developed to specifically assess the patient's perspective of outcome following shoulder arthroplasty. The OSS consists of twelve questions covering function and pain. To calculate the total score, each question is scored from 0 (worst outcome) to 4 (best outcome), and the sum of all 12 items is reported with a maximum of 48, representing the best score possible. The outcome score can be categorized as: Satisfactory Joint Function: 40 - 48, Moderate-Mild Arthritis: 30 - 39, Moderate-Severe Arthritis: 20 - 29, Severe Arthritis: 0 - 19.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2022
- Study start2 Dec 2022
- Primary completion30 Jun 2024
- Study completion30 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Bankart LesionsStudies of the same condition, open and under way.
- More trials run by Zimmer BiometThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 214 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zimmer Biomet
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Hassan ACHAKRI, Study director, Zimmer Biomet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05584553
- Sponsor's protocol ID
- MDRG2017-89MS-70SM
- Status last verified
- Dec 2024
- First submitted
- 25 Apr 2022
- Last updated
- 28 Nov 2025
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05584553
- Acronym / sponsor ID
- MDRG2017-89MS-70SM
- Conditions
- Bankart Lesions, SLAP Lesion, Acromioclavicular; Dislocation, Capsular Shift/Capsulolabral Reconstruction, Deltoid Repair, Rotator Cuff Tear Repair
- Keywords
- Post-Market Clinical Follow-Up Study, Medical Device, Performance, Safety, Clinical Benefits
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 214 participants (actual)
- Lead sponsor
- Zimmer BiometIndustry (pharma, biotech, devices)
- Study start
- 2 Dec 2022 (actual)
- Primary completion
- 30 Jun 2024 (actual)
- Study completion
- 30 Jun 2024 (actual)
- First posted
- 18 Oct 2022 (actual)
- Results
- Posted 28 Nov 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ToggleLoc 2.9 mm soft tissue device | – | Device: ToggleLoc 2.9 mm soft tissue devicePatients who already received the ToggleLoc 2.9 mm soft tissue device in the shoulder. No additional surgery will be performed. |
| JuggerLoc soft tissue device | – | Device: JuggerLoc soft tissue devicePatients who already received the JuggerLoc soft tissue device in the shoulder. No additional surgery will be performed. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ToggleLoc 2.9 mm soft tissue deviceThe 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 | ToggleLoc 2.9 mm soft tissue device |
| JuggerLoc soft tissue deviceThe JuggerLoc 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 |
Primary outcome
Number of Participants With Evidence of Soft Tissue-to-Bone Healing in the Shoulder
Time frame: 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)
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.
3 secondary outcomes
Number of Participants With Revision Surgery
Time frame: 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)
Time frame: 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)
Time frame: 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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Nov 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for Bankart Lesions
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hassan ACHAKRI study director
Zimmer Biomet
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bankart Lesions and SLAP Lesion, run by Zimmer Biomet at 3 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Spain, United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 28 Nov 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Evidence of Soft Tissue-to-Bone Healing in the Shoulder (time frame: 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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Nov 2025.