Trial Outcomes & Findings for PMCF Study on the Safety, Performance and Clinical Benefits Data of the ToggleLoc™ 2.9mm in the Elbow (NCT NCT05519228)
NCT ID: NCT05519228
Last Updated: 2025-01-30
Results Overview
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.
COMPLETED
83 participants
From operation to the study completion, minimum 1 year post-op.
2025-01-30
Participant Flow
Participant milestones
| Measure |
Patients Suffering From Biceps Tendon Rupture
Patients in need of a ToggleLoc 2.9mm in the Elbow for biceps tendon reattachment
|
|---|---|
|
Overall Study
STARTED
|
83
|
|
Overall Study
COMPLETED
|
83
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Patients Suffering From Biceps Tendon Rupture
n=83 Participants
Patients in need of a ToggleLoc 2.9mm in the Elbow for biceps tendon reattachment
|
|---|---|
|
Age, Continuous
|
46.3 "years"
STANDARD_DEVIATION 8.1 • n=83 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=83 Participants
|
|
Sex: Female, Male
Male
|
82 Participants
n=83 Participants
|
|
Height
|
177.0 "cm"
STANDARD_DEVIATION 7.5 • n=77 Participants • As only data on height on 77 cases was available, the BMI could also only be calculated for 77 cases.
|
|
Weight
|
91.8 "kg"
STANDARD_DEVIATION 19.0 • n=83 Participants
|
|
BMI
|
29.0 "kg/m2"
STANDARD_DEVIATION 4.9 • n=77 Participants • As only data on height on 77 cases was available, the BMI could also only be calculated for 77 cases.
|
PRIMARY outcome
Timeframe: From operation to the study completion, minimum 1 year post-op.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.
Outcome measures
| Measure |
ToggleLoc 2.9 mm Soft Tissue Device
n=83 Participants
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
|
|---|---|
|
Soft Tissue to Bone Healing in the Elbow - Hook Test
|
83 Participants
|
SECONDARY outcome
Timeframe: At minimum 1 year post-op.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".
Outcome measures
| Measure |
ToggleLoc 2.9 mm Soft Tissue Device
n=83 Participants
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
|
|---|---|
|
EuroQol Five-dimensional Health Questionnaire (EQ-5D-5L): Visual Analogue Scale (VAS)
|
83.3 score on a scale
Standard Deviation 14.9
|
SECONDARY outcome
Timeframe: At minimum 1 year post-op.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.
Outcome measures
| Measure |
ToggleLoc 2.9 mm Soft Tissue Device
n=83 Participants
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
|
|---|---|
|
EuroQol Five-dimensional Health Questionnaire (EQ-5D-5L): EQ-5D-5L Profile
|
1.0 score on a scale
Standard Deviation 0.1
|
SECONDARY outcome
Timeframe: At minimum 1 year post-op.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).
Outcome measures
| Measure |
ToggleLoc 2.9 mm Soft Tissue Device
n=83 Participants
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
|
|---|---|
|
Oxford Elbow Score (OES)
|
46.7 score on a scale
Standard Deviation 3.2
|
Adverse Events
ToggleLoc 2.9 mm Soft Tissue Device
Serious adverse events
| Measure |
ToggleLoc 2.9 mm Soft Tissue Device
n=83 participants at risk
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
|
|---|---|
|
Nervous system disorders
Serious Adverse Event (SAE)
|
1.2%
1/83 • 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.
|
Other adverse events
| Measure |
ToggleLoc 2.9 mm Soft Tissue Device
n=83 participants at risk
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
|
|---|---|
|
Nervous system disorders
Adverse Events (AE)
|
2.4%
2/83 • 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.
|
|
Musculoskeletal and connective tissue disorders
Adverse Events (AE)
|
1.2%
1/83 • 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.
|
|
Skin and subcutaneous tissue disorders
Adverse Events (AE)
|
1.2%
1/83 • 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.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60