PMCF Study on the Safety, Performance and Clinical Benefits Data of the ToggleLoc™ 2.9mm in the Elbow

Biceps Tendon Disorder Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05519228
• Other study ID #: MDRG2017-89MS-72SM
• Status: Active, not recruiting
• Start date: September 12, 2022
• Est. completion date: February 2024

Study information

• Verified date: December 2023
• Source: Zimmer Biomet
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 83
• Est. completion date: February 2024
• Est. primary completion date: February 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Biceps Tendon Disorder
• Epicondylitis of the Elbow
• Tendinopathy

Intervention

Device:
• 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

Locations

Country	Name	City	State
Spain	ASEPEYO Hospital	Madrid
United States	OrthoVirginia	Fairfax	Washington

Sponsors (1)

Lead Sponsor	Collaborator
Zimmer Biomet

Countries where clinical trial is conducted

United States,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Soft tissue to bone healing in the elbow	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 a combined assessment of pain, ROM and activity level.	From operation to the study completion, minimum 1 year post-op.
Secondary	Incidence and frequency of revision	Safety will be evaluated by recording and analyzing the incidence and frequency of revisions. A Kaplan Meier survival curve will be calculated.	From operation to the study completion, minimum 1 year post-op.
Secondary	EuroQol five-dimensional Health Questionnaire (EQ-5D-5L)	Assessment of patient-reported outcome measures (PROMs): The EuroQol fivedimensional Health Questionnaire (EQ-5D-5L) is a generic instrument. The EQ-5D-5L is scored on a 0 to 100 mm scale. 0 mm represents "the worst..." and 100 mm represents "the best health you can imagine".	From pre-operative to the study completion, minimum 1 year post-op.
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).	From pre-operative to the study completion, minimum 1 year post-op.