Acromioclavicular; Dislocation, Bankart Lesions, Biceps Tendon Disorder, Capsular Shift/Capsulolabral Reconstruction, Deltoid Repair, Rotator Cuff Tear Repair, SLAP Lesion
Conditions
Keywords
Post-Market Clinical Follow-Up Study, Medical Device, Performance, Safety, Clinical Benefits
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).
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.
Interventions
DEVICEToggleLoc 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.
DEVICEJuggerLoc 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.
Sponsors
Zimmer Biomet
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Evidence of Soft Tissue-to-Bone Healing in the Shoulder | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. | 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. |
| 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 | 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'). |
| 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. | 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. |
Countries
Spain, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 106 |
| 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. | 108 |
| Total | 214 |
Baseline characteristics
| Characteristic | ToggleLoc 2.9 mm Soft Tissue Device | JuggerLoc Soft Tissue Device | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 9 Participants | 13 Participants | 22 Participants |
| Age, Categorical Between 18 and 65 years | 97 Participants | 95 Participants | 192 Participants |
| Age, Continuous | 54.7 Years STANDARD_DEVIATION 9 | 47.1 Years STANDARD_DEVIATION 11.3 | 50.2 Years STANDARD_DEVIATION 10.2 |
| Body Mass Index of participants | 30.1 kg/m² STANDARD_DEVIATION 5.6 | 29.1 kg/m² STANDARD_DEVIATION 5.1 | 29.5 kg/m² STANDARD_DEVIATION 5.3 |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Region of Enrollment Spain | 26 Participants | 68 Participants | 94 Participants |
| Region of Enrollment United States | 80 Participants | 40 Participants | 120 Participants |
| Sex: Female, Male Female | 26 Participants | 24 Participants | 50 Participants |
| Sex: Female, Male Male | 80 Participants | 84 Participants | 164 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 106 | 0 / 108 |
| other Total, other adverse events | 23 / 106 | 1 / 108 |
| serious Total, serious adverse events | 0 / 106 | 1 / 108 |
Outcome results
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.
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)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| ToggleLoc 2.9 mm Soft Tissue Device | Number of Participants With Evidence of Soft Tissue-to-Bone Healing in the Shoulder | 106 participants |
| JuggerLoc Soft Tissue Device | Number of Participants With Evidence of Soft Tissue-to-Bone Healing in the Shoulder | 108 participants |
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').
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| ToggleLoc 2.9 mm Soft Tissue Device | EuroQol Five-dimensional Health Questionnaire (EQ-5D-5L) | 79.6 score on a scale | Standard Deviation 16.2 |
| JuggerLoc Soft Tissue Device | EuroQol Five-dimensional Health Questionnaire (EQ-5D-5L) | 84.9 score on a scale | Standard Deviation 10.9 |
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.
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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| ToggleLoc 2.9 mm Soft Tissue Device | Number of Participants With Revision Surgery | 0 Participants |
| JuggerLoc Soft Tissue Device | Number of Participants With Revision Surgery | 0 Participants |
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.
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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| ToggleLoc 2.9 mm Soft Tissue Device | Oxford Shoulder Score (OSS) | 45.4 score on a scale | Standard Deviation 5.4 |
| JuggerLoc Soft Tissue Device | Oxford Shoulder Score (OSS) | 45.5 score on a scale | Standard Deviation 5 |