N/A
N=83
PMCF Study on the Safety, Performance and Clinical Benefits Data of the ToggleLoc™ 2.9mm in the Elbow
Epicondylitis of the Elbow · Biceps Tendon Disorder
Bottom Line
View on ClinicalTrials.gov: NCT05519228 ↗Enrolled (actual)
83
Serious AEs
1.2%
Results posted
Nov 2024
Primary outcome: Primary: Soft Tissue to Bone Healing in the Elbow - Hook Test — 83 Participants
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- ToggleLoc 2.9 mm Soft Tissue System (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Zimmer Biomet
- Primary completion
- Sep 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Soft Tissue to Bone Healing in the Elbow - Hook Test |
83 | — |
| SECONDARY EuroQol Five-dimensional Health Questionnaire (EQ-5D-5L): Visual Analogue Scale (VAS) |
83.3 | — |
| SECONDARY EuroQol Five-dimensional Health Questionnaire (EQ-5D-5L): EQ-5D-5L Profile |
1.0 | — |
| SECONDARY Oxford Elbow Score (OES) |
46.7 | — |
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).
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT05519228). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.