Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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).
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
| |
| JuggerLoc soft tissue device | Patients who already received the JuggerLoc soft tissue device in the shoulder. No additional surgery will be performed. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
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.
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Hassan ACHAKRI | Zimmer Biomet | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Advanced Bone and Joint | City of Saint Peters | Missouri | 63376 | United States | ||
| Centro Médico Quirónsalud |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 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. 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. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 22, 2021 |
Not provided
Not provided
Not provided
Not provided
| 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. |
|
| 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'). | 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. | 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. |
| Alicante |
| 03184 |
| Spain |
| Hospital Universitario Quirónsalud | Madrid | 28223 | Spain |
| FG001 | JuggerLoc Soft Tissue Device | Patients who already received the JuggerLoc soft tissue device in the shoulder. No additional surgery will be performed. 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. |
| COMPLETED |
|
| NOT COMPLETED |
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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. 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. |
| BG001 | JuggerLoc Soft Tissue Device | Patients who already received the JuggerLoc soft tissue device in the shoulder. No additional surgery will be performed. 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. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||
| Age, Continuous | Mean | Standard Deviation | Years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
| |||||||||||||||
| Region of Enrollment | Count of Participants | Participants |
| ||||||||||||||||
| Body Mass Index of participants | Mean | Standard Deviation | kg/m² |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Number | participants | 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) | Implants | Implants |
|
|
| ||||||||||||||||||||||||||||||
| Secondary | 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. | Posted | Count of Participants | Participants | 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. |
| ||||||||||||||||||||||||||||||||||
| Secondary | 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'). | Posted | Mean | Standard Deviation | score on a scale | 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 |
| |||||||||||||||||||||||||||||||||
| Secondary | 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. | Posted | Mean | Standard Deviation | score on a scale | 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. |
|
From date of surgery to last available follow-up (mean = 2.1 ± 1.1 years for the JuggerLoc arm and 3.5 ± 2.0 years for the ToggleLoc arm)
Adverse events were prospectively collected using the Oracle RDC electronic data-capture system. For each event, the date of occurrence, event type, relationship to the study device, treatment provided, and treatment outcome were recorded.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. 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. | 0 | 106 | 0 | 106 | 23 | 106 |
| EG001 | JuggerLoc Soft Tissue Device | Patients who already received the JuggerLoc soft tissue device in the shoulder. No additional surgery will be performed. 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. | 0 | 108 | 1 | 108 | 1 | 108 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| GULLIAN BARRE SYNDROME | Nervous system disorders | Systematic Assessment | PATIENT DIAGNOSED WITH GULLIAN BARRE SYNDROME. WAS HOSPILIZED 84 DAYS. CURRENTLY IN REHAB. SHOULDER IS DOING GREAT |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| SEVERE BLISTERING FROM THE TAPE. | Skin and subcutaneous tissue disorders | Systematic Assessment | 2 DAYS POST OP [ PATIENT HAD "SEVERE" BLISTERING FROM THE TAPE. IT RESOLVED BUT HAS SCARRING](streamdown:incomplete-link) |
| |
| Urinary | Renal and urinary disorders | Systematic Assessment | PATIENT RECALLS NOT BEING ABLE TO URINATE. WENT TO THE ED AND CATHETER WAS PLACED. PCP EVENTUALLY REMOVED. |
| |
| Bleeding | Surgical and medical procedures | Systematic Assessment | PATIENT CAME IN POD 1 WITH BLEEDING CONCERNS. NO ACTIVE BLEEDING. NEW DRESSING APPLIED. POST OP VISIT: THE INCISION LOOKED FINE |
| |
| Bleeding | Surgical and medical procedures | Systematic Assessment | PATIENT CAME INTO THE OFFICE FOR EARLY FOLLOW UP FOR BLEEDING CONCERNS. NO ACTIVE BLEEDING. DRESSING REAPPLIED |
| |
| Chest Pain | Cardiac disorders | Systematic Assessment | PATIENT RECALLS CHEST PAIN AND ADMITTED THRU ED. H/O 1992 STENTING AND MI. 1/31/18 OFFICE NOTE STATES HE SAW CARDIOLOGY AND WAS GETTING A WORK UP THAT DAY. . |
| |
| Bicep Pain | Nervous system disorders | Systematic Assessment | POST OP VISIT PATIENT MENTIONS N/T AROUND BICEP INCISION. NO MENTION AT FUTURE APPTS. |
| |
| Knee Injection | Musculoskeletal and connective tissue disorders | Systematic Assessment | SEEN FOR 3RD RIGHT KNEE EUFLEXXA INJECTION (FIRST TWO PRIOR INJECTIONS GIVEN PRIOR TO SHOULDER SURGERY.) |
| |
| Rash | Skin and subcutaneous tissue disorders | Systematic Assessment | POST OP VISIT PATIENT HAD A RASH UNDER OPERATED ARM |
| |
| Small Wound | Infections and infestations | Systematic Assessment | SMALL WOUND DEHISCENCE WHICH REQUIRED ANTIBIOTICS |
| |
| Neck, Back Pain | Musculoskeletal and connective tissue disorders | Systematic Assessment | EARLY FOLLOW UP DUE TO NECK, MID-BACL, AND SCAPULA PAIN THAT STARTED A FEW DAYS |
| |
| Stroke | Nervous system disorders | Systematic Assessment | FOLLOW UP: STATES PATIENT IS DOING STROKE REHAB. |
| |
| LATERAL EPICONDYLITIS | Musculoskeletal and connective tissue disorders | Systematic Assessment | REPORTS NUMBNESS IN FOREARM AND ELBOW PAIN. LATERAL EPICONDYLITIS- NO ADDITIONAL TREATMENT |
| |
| RIGHT SHOULDER PAIN | Musculoskeletal and connective tissue disorders | Systematic Assessment | Patient HAVING RIGHT SHOULDER PAIN-REPORTS "LONG HISTORY" OF RIGHT SHOULDER PAIN- SHOULDER XRAY AND EVALUATED BUT PATIENT DIDNT WANT FUTHUR TREATMENT |
| |
| Pain | General disorders | Systematic Assessment | THE PATIENT HAD INCREASED PAIN AFTER WORKING OUT. WENT TO PT. DID GET BETTER. NORMAL EXAM |
| |
| Shoulder Pain | Musculoskeletal and connective tissue disorders | Systematic Assessment | RIGHT SHOULDER PAIN - NON Study Related |
| |
| Left Hand Pain | Nervous system disorders | Systematic Assessment | Left Hand Pain (non study related) - Patient doesn't want to Follow up |
| |
| Hip Pain | Musculoskeletal and connective tissue disorders | Systematic Assessment | Hip Pain - Resolved |
| |
| Patient Fell | General disorders | Systematic Assessment | PATIENT FELL ON LEFT SIDE GETTING INTO A VAN |
| |
| Carpal tunnel syndrome | Musculoskeletal and connective tissue disorders | Systematic Assessment | Patient experienced pain in left hand - Diagnosed with Carpal tunnel syndrome |
| |
| Hand Pain | Nervous system disorders | Systematic Assessment | HAND PAIN. INJECTION GIVEN LEFT HAND. Resolved |
| |
| Knee Pain | Musculoskeletal and connective tissue disorders | Systematic Assessment | Knee Pain - Injections, resolved |
| |
| Fracture | Musculoskeletal and connective tissue disorders | Systematic Assessment | NON DISPLACED ANKLE FRACTURE. NON OPERATIVE TREATMENT |
| |
| PAIN | Nervous system disorders | Systematic Assessment | PERSISTANCE PAIN (NON STUDY RELATED), INJECTION. DEPO MEDROL 40MG AND 1% LIDOCAINE |
| |
| Injury | General disorders | Systematic Assessment | REPORTS INJURY WHEN GRABBING A DOOR WEEKS AGO. HAD INCREASED PAIN. IMPROVED OVER LAST FEW WEEKS |
|
The retrospective setting of the study
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Nesma Bayrich | Zimmer Biomet | +41793001484 | nesma.bayrich@zimmerbiomet.com |
| Nov 10, 2025 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D000070896 | Bankart Lesions |
| D004204 | Joint Dislocations |
| ID | Term |
|---|---|
| D012784 | Shoulder Fractures |
| D050723 | Fractures, Bone |
| D014947 | Wounds and Injuries |
| D000070599 | Shoulder Injuries |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
Not provided
Not provided
| Between 18 and 65 years |
|
| >=65 years |
|
|
|
|
|
| Spain |
|
|
|
|
|
| OG001 |
| JuggerLoc Soft Tissue Device |
Patients who already received the JuggerLoc soft tissue device in the shoulder. No additional surgery will be performed. 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. |
|
|
|
|