Biceps Tendon Disorder, Epicondylitis of the Elbow
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 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).
Detailed description
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.
Interventions
DEVICEToggleLoc 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
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 who received the ToggleLoc 2.9 mm Soft Tissue device for soft tissue to bone fixation in the elbow. * 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 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 |
|---|---|---|
| Soft Tissue to Bone Healing in the Elbow - Hook Test | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| EuroQol Five-dimensional Health Questionnaire (EQ-5D-5L): Visual Analogue Scale (VAS) | 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. |
| EuroQol Five-dimensional Health Questionnaire (EQ-5D-5L): EQ-5D-5L Profile | 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. |
| Oxford Elbow Score (OES) | 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). |
Countries
Spain, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Patients Suffering From Biceps Tendon Rupture Patients in need of a ToggleLoc 2.9mm in the Elbow for biceps tendon reattachment | 83 |
| Total | 83 |
Baseline characteristics
| Characteristic | Patients Suffering From Biceps Tendon Rupture | — |
|---|---|---|
| Age, Continuous | 46.3 years STANDARD_DEVIATION 8.1 | — |
| BMI | 29.0 kg/m2 STANDARD_DEVIATION 4.9 | — |
| Height | 177.0 cm STANDARD_DEVIATION 7.5 | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Sex: Female, Male Female | 1 Participants | — |
| Sex: Female, Male Male | 82 Participants | — |
| Weight | 91.8 kg STANDARD_DEVIATION 19 | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 83 |
| other Total, other adverse events | 13 / 83 |
| serious Total, serious adverse events | 1 / 83 |
Outcome results
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.
Time frame: From operation to the study completion, minimum 1 year post-op.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| ToggleLoc 2.9 mm Soft Tissue Device | Soft Tissue to Bone Healing in the Elbow - Hook Test | 83 Participants |
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.
Time frame: At minimum 1 year post-op.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| ToggleLoc 2.9 mm Soft Tissue Device | EuroQol Five-dimensional Health Questionnaire (EQ-5D-5L): EQ-5D-5L Profile | 1.0 score on a scale | Standard Deviation 0.1 |
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.
Time frame: At minimum 1 year post-op.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| ToggleLoc 2.9 mm Soft Tissue Device | EuroQol Five-dimensional Health Questionnaire (EQ-5D-5L): Visual Analogue Scale (VAS) | 83.3 score on a scale | Standard Deviation 14.9 |
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).
Time frame: At minimum 1 year post-op.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| ToggleLoc 2.9 mm Soft Tissue Device | Oxford Elbow Score (OES) | 46.7 score on a scale | Standard Deviation 3.2 |