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

NCT05519228 | Completed Results FDA Device

• 1 other identifier: MDRG2017-89MS-72SM
• Study Type: observational
• Target: 83
• Locations: 2 countries
• Sites: 2

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).

Conditions

Epicondylitis of the Elbow; Biceps Tendon Disorder

Keywords

Post-Market Clinical Follow-Up Study; Medical Device; Performance; Safety; Clinical Benefits

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• EuroQol Five-dimensional Health Questionnaire (EQ-5D-5L): Visual Analogue Scale (VAS)

  At minimum 1 year post-op.

• EuroQol Five-dimensional Health Questionnaire (EQ-5D-5L): EQ-5D-5L Profile

  At minimum 1 year post-op.

• Oxford Elbow Score (OES)

  At minimum 1 year post-op.

Study Arms (1)

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

Interventions

ToggleLoc 2.9 mm Soft Tissue System DEVICE

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

ToggleLoc 2.9 mm soft tissue device

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Zimmer Biomet: lead

Study Sites (2)

OrthoVirginia

Fairfax, Washington, 22033, United States

Location

ASEPEYO Hospital

Madrid, 28823, Spain

Location

Limitations and Caveats

A limitation to this study is its retrospective design. Due to this, no data on preoperative PROMs (Oxford Elbow Score) and patient questionnaires (EQ-5D-5L Profile/VAS) were collected and therefore, no comparison to postoperative PROMs and patient questionnaires could be drawn.

Results Point of Contact

• Title: Andrea Singer
• Organization: ZimmerBio

andrea.singer@zimmerbiomet.com

(0)79 318 06 55

Study Officials

• Hassan ACHAKRI

  Zimmer Biomet

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 1, 2022
• First Posted: August 29, 2022
• Study Start: September 12, 2022
• Primary Completion: September 27, 2023
• Study Completion: February 20, 2024
• Last Updated: January 30, 2025
• Results First Posted: November 12, 2024

Record last verified: 2023-12

Locations

US (1); ES (1)