Trial Outcomes & Findings for PMCF Study on the Safety, Performance and Clinical Benefits Data of the ToggleLoc™ 2.9mm and JuggerLoc™ in the Shoulder (NCT NCT05584553)

Last Updated: 2025-11-28

Results Overview

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.

Recruitment status

COMPLETED

Target enrollment

214 participants

Primary outcome timeframe

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)

Results posted on

2025-11-28

Participant Flow

Participant milestones

Participant milestones
Measure	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.	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.
Overall Study STARTED	106	108
Overall Study COMPLETED	106	108
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	ToggleLoc 2.9 mm Soft Tissue Device n=106 Participants 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.	JuggerLoc Soft Tissue Device n=108 Participants 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.	Total n=214 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=106 Participants	0 Participants n=108 Participants	0 Participants n=214 Participants
Age, Categorical Between 18 and 65 years	97 Participants n=106 Participants	95 Participants n=108 Participants	192 Participants n=214 Participants
Age, Categorical >=65 years	9 Participants n=106 Participants	13 Participants n=108 Participants	22 Participants n=214 Participants
Age, Continuous	54.7 Years STANDARD_DEVIATION 9.0 • n=106 Participants	47.1 Years STANDARD_DEVIATION 11.3 • n=108 Participants	50.2 Years STANDARD_DEVIATION 10.2 • n=214 Participants
Sex: Female, Male Female	26 Participants n=106 Participants	24 Participants n=108 Participants	50 Participants n=214 Participants
Sex: Female, Male Male	80 Participants n=106 Participants	84 Participants n=108 Participants	164 Participants n=214 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment United States	80 Participants n=106 Participants	40 Participants n=108 Participants	120 Participants n=214 Participants
Region of Enrollment Spain	26 Participants n=106 Participants	68 Participants n=108 Participants	94 Participants n=214 Participants
Body Mass Index of participants	30.1 kg/m² STANDARD_DEVIATION 5.6 • n=106 Participants	29.1 kg/m² STANDARD_DEVIATION 5.1 • n=108 Participants	29.5 kg/m² STANDARD_DEVIATION 5.3 • n=214 Participants

PRIMARY outcome

Timeframe: 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)

Outcome measures

Outcome measures
Measure	ToggleLoc 2.9 mm Soft Tissue Device n=106 Implants 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.	JuggerLoc Soft Tissue Device n=108 Implants 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.
Number of Participants With Evidence of Soft Tissue-to-Bone Healing in the Shoulder	106 participants	108 participants

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	ToggleLoc 2.9 mm Soft Tissue Device n=106 Participants 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.	JuggerLoc Soft Tissue Device n=108 Participants 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.
Number of Participants With Revision Surgery	0 Participants	0 Participants

SECONDARY outcome

Timeframe: 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

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').

Outcome measures

Outcome measures
Measure	ToggleLoc 2.9 mm Soft Tissue Device n=106 Participants 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.	JuggerLoc Soft Tissue Device n=108 Participants 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.
EuroQol Five-dimensional Health Questionnaire (EQ-5D-5L)	79.6 score on a scale Standard Deviation 16.2	84.9 score on a scale Standard Deviation 10.9

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	ToggleLoc 2.9 mm Soft Tissue Device n=106 Participants 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.	JuggerLoc Soft Tissue Device n=108 Participants 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.
Oxford Shoulder Score (OSS)	45.4 score on a scale Standard Deviation 5.4	45.5 score on a scale Standard Deviation 5.0

Adverse Events

ToggleLoc 2.9 mm Soft Tissue Device

Serious events: 0 serious events

Other events: 23 other events

Deaths: 0 deaths

JuggerLoc Soft Tissue Device

Serious events: 1 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	ToggleLoc 2.9 mm Soft Tissue Device n=106 participants at risk 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.	JuggerLoc Soft Tissue Device n=108 participants at risk 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.
Nervous system disorders GULLIAN BARRE SYNDROME	0.00% 0/106 • 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.	0.93% 1/108 • Number of events 1 • 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.

Other adverse events

Additional Information

Dr Nesma Bayrich

Zimmer Biomet

Phone: +41793001484

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60

Measure	ToggleLoc 2.9 mm Soft Tissue Device n=106 participants at risk 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.	JuggerLoc Soft Tissue Device n=108 participants at risk 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.
Skin and subcutaneous tissue disorders SEVERE BLISTERING FROM THE TAPE.	0.00% 0/106 • 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.	100.0% 1/1 • Number of events 1 • 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.
Renal and urinary disorders Urinary	0.94% 1/106 • Number of events 1 • 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.	0.00% 0/108 • 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.
Surgical and medical procedures Bleeding	0.94% 1/106 • Number of events 1 • 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.	0.00% 0/108 • 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.
Cardiac disorders Chest Pain	0.94% 1/106 • Number of events 1 • 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.	0.00% 0/108 • 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.
Nervous system disorders Bicep Pain	0.94% 1/106 • Number of events 1 • 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.	0.00% 0/108 • 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.
Musculoskeletal and connective tissue disorders Knee Injection	0.94% 1/106 • Number of events 1 • 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.	0.00% 0/108 • 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.
Skin and subcutaneous tissue disorders Rash	0.94% 1/106 • Number of events 1 • 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.	0.00% 0/108 • 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.
Infections and infestations Small Wound	0.94% 1/106 • Number of events 1 • 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.	0.00% 0/108 • 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.
Musculoskeletal and connective tissue disorders Neck, Back Pain	0.94% 1/106 • Number of events 1 • 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.	0.00% 0/108 • 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.
Nervous system disorders Stroke	0.94% 1/106 • Number of events 1 • 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.	0.00% 0/108 • 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.
Musculoskeletal and connective tissue disorders LATERAL EPICONDYLITIS	0.94% 1/106 • Number of events 1 • 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.	0.00% 0/108 • 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.
Musculoskeletal and connective tissue disorders RIGHT SHOULDER PAIN	0.94% 1/106 • Number of events 1 • 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.	0.00% 0/108 • 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.
General disorders Pain	0.94% 1/106 • Number of events 1 • 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.	0.00% 0/108 • 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.
Musculoskeletal and connective tissue disorders Shoulder Pain	0.94% 1/106 • Number of events 1 • 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.	0.00% 0/108 • 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.
Nervous system disorders Left Hand Pain	0.94% 1/106 • Number of events 1 • 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.	0.00% 0/108 • 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.
Musculoskeletal and connective tissue disorders Hip Pain	0.94% 1/106 • Number of events 1 • 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.	0.00% 0/108 • 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.
General disorders Patient Fell	0.94% 1/106 • Number of events 1 • 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.	0.00% 0/108 • 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.
Musculoskeletal and connective tissue disorders Carpal tunnel syndrome	0.94% 1/106 • Number of events 1 • 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.	0.00% 0/108 • 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.
Nervous system disorders Hand Pain	0.94% 1/106 • Number of events 1 • 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.	0.00% 0/108 • 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.
Musculoskeletal and connective tissue disorders Knee Pain	0.94% 1/106 • Number of events 1 • 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.	0.00% 0/108 • 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.
Musculoskeletal and connective tissue disorders Fracture	0.94% 1/106 • Number of events 1 • 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.	0.00% 0/108 • 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.
Nervous system disorders PAIN	0.94% 1/106 • Number of events 1 • 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.	0.00% 0/108 • 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.
General disorders Injury	0.94% 1/106 • Number of events 1 • 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.	0.00% 0/108 • 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.