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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 Soft Tissue System when used for soft tissue to bone fixation in the elbow. The primary objective is the assessment of performance by analyzing soft tissue to bone healing in the elbow.
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 Soft Tissue System consist of non-resorbable device 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 elbow requiring soft tissue to bone fixation and to relieve pain that cannot be controlled by other treatments.
Two sites will be involved in this study. The aim is to include a total of 83 consecutive series cases operated with the ToggleLoc 2.9 mm in the elbow. 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.
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| 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 elbow. No additional surgery will be performed. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ToggleLoc 2.9 mm Soft Tissue System | Device | The ToggleLoc 2.9 mm Soft Tissue System consist of non-resorbable device intended to aid in arthroscopic and orthopaedic reconstructive procedures requiring soft tissue to bone fixation |
| Measure | Description | Time Frame |
|---|---|---|
| Soft Tissue to Bone Healing in the Elbow - Hook Test | Assessment of performance by analyzing soft tissue to bone healing in the elbow. The principal investigator will clinically evaluate the study elbow to assess if soft tissue to bone healing has occurred using the Hook test. The Hook test is performed by hooking the finger, that is inserted laterally under the biceps tendon, under the cord-like structure spanning the antecubital fossa with the patient's elbow flexed at 90 degrees. Each case that a Hook test was performed on will be counted as 1 count and will be described as "1 case" if successful, meaning this case had successful soft tissue to bone healing. | From operation to the study completion, minimum 1 year post-op. |
| Measure | Description | Time Frame |
|---|---|---|
| EuroQol Five-dimensional Health Questionnaire (EQ-5D-5L): Visual Analogue Scale (VAS) | Assessment of patient-reported outcome measures (PROMs): The EuroQol fivedimensional Health Questionnaire (EQ-5D-5L) is a generic instrument. The EQ-5D-5L VAS is scored on a 0 to 100 mm scale. 0 mm represents "the worst..." and 100 mm represents "the best health you can imagine". | At minimum 1 year post-op. |
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Inclusion Criteria:
Exclusion Criteria:
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Patients who had required a soft tissue to bone fixation in the elbow with the ToggleLoc 2.9 mm Soft Tissue device according to Zimmer Biomet's Instruction for Use (IFU) and and who meet all the inclusions criteria and none of the exclusions criteria.
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| Name | Affiliation | Role |
|---|---|---|
| Hassan ACHAKRI | Zimmer Biomet | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| OrthoVirginia | Fairfax | Washington | 22033 | United States | ||
| ASEPEYO Hospital |
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| ID | Title | Description |
|---|---|---|
| FG000 | Patients Suffering From Biceps Tendon Rupture | Patients in need of a ToggleLoc 2.9mm in the Elbow for biceps tendon reattachment |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Patients Suffering From Biceps Tendon Rupture | Patients in need of a ToggleLoc 2.9mm in the Elbow for biceps tendon reattachment |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Soft Tissue to Bone Healing in the Elbow - Hook Test | Assessment of performance by analyzing soft tissue to bone healing in the elbow. The principal investigator will clinically evaluate the study elbow to assess if soft tissue to bone healing has occurred using the Hook test. The Hook test is performed by hooking the finger, that is inserted laterally under the biceps tendon, under the cord-like structure spanning the antecubital fossa with the patient's elbow flexed at 90 degrees. Each case that a Hook test was performed on will be counted as 1 count and will be described as "1 case" if successful, meaning this case had successful soft tissue to bone healing. | Posted | Count of Participants | Participants | From operation to the study completion, minimum 1 year post-op. |
|
Reported Adverse Events (AEs) include events from the date each subject was implanted up to 6.1 years after surgery, when the last follow-up was performed and patients completed the study.
Adverse Events were collected in an Electronic Data Capturing system called Oracle RDC, which gathers information of the date of occurrence, the nature of the adverse event, whether the device was involved, which treatment was used and the treatment outcome.
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| 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 elbow. No additional surgery will be performed. ToggleLoc 2.9 mm Soft Tissue System: The ToggleLoc 2.9 mm Soft Tissue System consist of non-resorbable device intended to aid in arthroscopic and orthopaedic reconstructive procedures requiring soft tissue to bone fixation |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Serious Adverse Event (SAE) | Nervous system disorders | Systematic Assessment | Amyotrophic Lateral Sclerosis (ALS) |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Adverse Events (AE) | Nervous system disorders | Systematic Assessment | Median nerve dysesthesia |
A limitation to this study is its retrospective design. Due to this, no data on preoperative PROMs (Oxford Elbow Score) and patient questionnaires (EQ-5D-5L Profile/VAS) were collected and therefore, no comparison to postoperative PROMs and patient questionnaires could be drawn.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Andrea Singer | ZimmerBio | (0)79 318 06 55 | +41 | andrea.singer@zimmerbiomet.com |
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| 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 | Sep 20, 2022 | Aug 13, 2024 | Prot_SAP_000.pdf |
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| EuroQol Five-dimensional Health Questionnaire (EQ-5D-5L): EQ-5D-5L Profile | Assessment of patient-reported outcome measures (PROMs): The EuroQol fivedimensional Health Questionnaire (EQ-5D-5L) is a generic instrument. In the EQ-5D-5L Profile the highest score is 1 and the lowest score is -0.573; negative numbers correspond to a self-assessed health state worse than being dead. | At minimum 1 year post-op. |
| Oxford Elbow Score (OES) | Assessment of patient-reported outcome measures (PROMs): The Oxford Elbow Score (OES) consists of 12 questionnaire items with five original response options each and is specifically designed and developed for assessing outcomes of elbow surgery. The score will be on a scale from 0 (worst) to 48 (best). | At minimum 1 year post-op. |
| Madrid |
| 28823 |
| Spain |
| "years" |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
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| Height | As only data on height on 77 cases was available, the BMI could also only be calculated for 77 cases. | Mean | Standard Deviation | "cm" |
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| Weight | Mean | Standard Deviation | "kg" |
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| BMI | As only data on height on 77 cases was available, the BMI could also only be calculated for 77 cases. | Mean | Standard Deviation | "kg/m2" |
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| Secondary | EuroQol Five-dimensional Health Questionnaire (EQ-5D-5L): Visual Analogue Scale (VAS) | Assessment of patient-reported outcome measures (PROMs): The EuroQol fivedimensional Health Questionnaire (EQ-5D-5L) is a generic instrument. The EQ-5D-5L VAS is scored on a 0 to 100 mm scale. 0 mm represents "the worst..." and 100 mm represents "the best health you can imagine". | Posted | Mean | Standard Deviation | score on a scale | At minimum 1 year post-op. |
|
|
|
| Secondary | EuroQol Five-dimensional Health Questionnaire (EQ-5D-5L): EQ-5D-5L Profile | Assessment of patient-reported outcome measures (PROMs): The EuroQol fivedimensional Health Questionnaire (EQ-5D-5L) is a generic instrument. In the EQ-5D-5L Profile the highest score is 1 and the lowest score is -0.573; negative numbers correspond to a self-assessed health state worse than being dead. | Posted | Mean | Standard Deviation | score on a scale | At minimum 1 year post-op. |
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| Secondary | Oxford Elbow Score (OES) | Assessment of patient-reported outcome measures (PROMs): The Oxford Elbow Score (OES) consists of 12 questionnaire items with five original response options each and is specifically designed and developed for assessing outcomes of elbow surgery. The score will be on a scale from 0 (worst) to 48 (best). | Posted | Mean | Standard Deviation | score on a scale | At minimum 1 year post-op. |
|
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| 0 |
| 83 |
| 1 |
| 83 |
| 13 |
| 83 |
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| Adverse Events (AE) | Nervous system disorders | Systematic Assessment | Paresthesia due to tick bite |
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| Adverse Events (AE) | Nervous system disorders | Systematic Assessment | Paresthesia |
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| Adverse Events (AE) | Nervous system disorders | Systematic Assessment | Medium neurapraxia |
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| Adverse Events (AE) | Nervous system disorders | Systematic Assessment | Hypoesthesia |
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| Adverse Events (AE) | Musculoskeletal and connective tissue disorders | Systematic Assessment | Lack of Flexion and Calcifications |
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| Adverse Events (AE) | Musculoskeletal and connective tissue disorders | Systematic Assessment | Lack of Supination |
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| Adverse Events (AE) | Musculoskeletal and connective tissue disorders | Systematic Assessment | Heterotopic Ossification at the repair site/forearm |
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| Adverse Events (AE) | Skin and subcutaneous tissue disorders | Systematic Assessment | Wound problems - infection |
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