Clinical trial NCT05519228: PMCF Study on the Safety, Performance and Clinical Benefits Data of the ToggleLoc™ 2.9mm in the Elbow
Official title: Post-market Clinical Follow-up Study to Provide Safety, Performance and Clinical Benefits Data of the ToggleLoc™ 2.9mm Soft Tissue System (Implants and Instrumentation) in the Elbow - A Multicenter Retrospective Consecutive Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Epicondylitis of the Elbow
Biceps Tendon Disorder
Keywords: Post-Market Clinical Follow-Up Study
Medical Device
Performance
Safety
Clinical Benefits
Lead sponsor: Zimmer Biomet
Sponsor class: INDUSTRY
First posted: 2022-08-29
Enrollment: 83
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

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.

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.

Primary outcomes:
measure: Soft Tissue to Bone Healing in the Elbow - Hook Test
timeFrame: From operation to the study completion, minimum 1 year post-op.
Secondary outcomes:
measure: EuroQol Five-dimensional Health Questionnaire (EQ-5D-5L): Visual Analogue Scale (VAS)
timeFrame: At minimum 1 year post-op.
measure: EuroQol Five-dimensional Health Questionnaire (EQ-5D-5L): EQ-5D-5L Profile
timeFrame: At minimum 1 year post-op.
measure: Oxford Elbow Score (OES)
timeFrame: At minimum 1 year post-op.
Other outcomes:
Locations:
city: Fairfax
country: United States
facility: OrthoVirginia
state: Washington
city: Madrid
country: Spain
facility: ASEPEYO Hospital
Study officials:
affiliation: Zimmer Biomet
name: Hassan ACHAKRI
role: STUDY_DIRECTOR
References: