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

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

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).

Study Overview

• Status: Completed
• Conditions: Epicondylitis of the Elbow; Biceps Tendon Disorder
• Intervention / Treatment: Device: ToggleLoc 2.9 mm Soft Tissue System

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.

• Study Type: Observational
• Enrollment (Actual): 83

Contacts and Locations

Study Locations

• Spain
  • Madrid, Spain, 28823
    • ASEPEYO Hospital
• United States
  • Washington
    • Fairfax, Washington, United States, 22033
      • OrthoVirginia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• 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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
ToggleLoc 2.9 mm soft tissue device; Patients who already received the ToggleLoc 2.9 mm soft tissue device in the elbow. No additional surgery will be performed.	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	From operation to the study completion, minimum 1 year post-op.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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".	At minimum 1 year post-op.
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.	At minimum 1 year post-op.
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).	At minimum 1 year post-op.

Collaborators and Investigators

• Sponsor: Zimmer Biomet
• Investigators: Study Director: Hassan Achakri, Zimmer Biomet

Study record dates

Study Major Dates

• Study Start (Actual): September 12, 2022
• Primary Completion (Actual): September 27, 2023
• Study Completion (Actual): February 20, 2024

Study Registration Dates

• First Submitted: June 1, 2022
• First Submitted That Met QC Criteria: August 24, 2022
• First Posted (Actual): August 29, 2022

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 28, 2025
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: Safety; Performance; Medical Device; Clinical Benefits; Post-Market Clinical Follow-Up Study
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Muscular Diseases; Wounds and Injuries; Tendon Injuries; Tendinopathy
• Other Study ID Numbers: MDRG2017-89MS-72SM

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes