Affixus Natural Nail System Humeral Nail PMCF

Humeral Fractures Clinical Trial

Official title:

Post-market Clinical Follow-up Study to Provide Safety, Performance and Clinical Benefits Data of the Affixus Natural Nail System Humeral Nail (Implants and Instrumentation)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05019664
• Other study ID #: CMG2020-09T
• Status: Recruiting
• Phase: N/A
• Start date: August 29, 2022
• Est. completion date: August 2027

Study information

• Verified date: April 2024
• Source: Zimmer Biomet
• Contact: Priscila Guedes, B.S.
• Phone: +41 79 891 14 25
• Email: priscila.guedes[@]zimmerbiomet.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

A commercially available product clinical study which aims to confirm the safety, performance and clinical benefits to the patient of the Affixus Natural Nail upper arm (humerus) bone nail system for both the implant itself and the instrumentation used during surgery.

Description:

Study objective: The objectives of this observational, prospective study with optional retrospective enrollment are to confirm safety, performance and clinical benefits of the Affixus Natural Nail System Humeral Nail and its instrumentation by analyzing adverse event records, fracture/osteotomy healing and functional outcome and adverse events. The safety of the system will be assessed by monitoring the frequency and incidence of adverse events. Relation of the events to implant, instrumentation and/or procedure should be specified. The performance and clinical benefits will be evaluated by assessment of fracture/osteotomy healing and functional outcome of all enrolled study subjects. Study Endpoints: Primary endpoint: The primary endpoint is bone union after 12 months since surgery. Secondary endpoint: The secondary endpoints will be evaluating functional outcomes (Range of Motion, & American Shoulder and Elbow Surgeons questionnaire), quality of life questionnaire (EQ-5D-5L), radiographic findings and adverse events including re-operation of all enrolled study subjects at the defined follow up time points.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: August 2027
• Est. primary completion date: August 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients 18 years or older and skeletally mature.
• Patient must have either a proximal humeral fracture or humeral shaft fracture requiring surgical intervention and be eligible for fixation by intramedullary nailing.
• Patient has been or is scheduled to be treated with the Affixus Natural Nail System Humeral Nail.
• Patient must be able and willing to complete the protocol required follow-up.
• Patient must have a signed Institutional Review Board/Ethics Committee approved informed consent. (An Institutional Review Board/Ethics Committee is group that has been formally designated to review and monitor medical research involving human subjects.)
• Patients capable of understanding the surgeon's explanations and following his instructions, able and willing to participate in the follow-up program and who gave consent to take part in the study.

Exclusion Criteria:

• Distal fracture involving the olecranon fossa.
• Bone shaft having excessive bow or deformity.
• A medullary canal obliterated by a previous fracture or tumor.
• Active or previous infection.
• Skeletally immature patients.
• All concomitant diseases that can impair the functioning and the success of the implant.
• Patients with mental or neurologic conditions who are unwilling or incapable of giving proper informed consent and following postoperative care instructions.
• 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).
• Patient known to be pregnant or breast feeding.
• Likely problems with maintaining follow-up program (e.g. patient with no fixed address, long distance, plans to move during course of study).
• Patients who have any condition that would in the judgment of the investigator place the patient at undue risk or interfere with the study.
• Not expected to survive the duration of the follow-up program.

Related Conditions & MeSH terms

• Fractures, Bone
• Humeral Fractures
• Humeral Fractures, Proximal
• Shoulder Fractures

Intervention

Device:
• Affixus Natural Nail System
Intramedullary nailing designed for fixation and stabilization of fractures or osteotomies of the humerus. Nails are comprised of proximal and antegrade/retrograde.

Locations

Country	Name	City	State
Belgium	UZ Leuven - Traumatology Department	Leuven
Spain	Hospital de la Santa Creu i Sant Pau	Barcelona
Switzerland	Kantonsspital Frauenfeld	Frauenfeld	Thurgau
United States	University of Texas Health Science Center at San Antonio	San Antonio	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Zimmer Biomet

Countries where clinical trial is conducted

United States,  Belgium,  Spain,  Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Bone Union	The primary endpoint is bone union after 12 months since surgery. (Bone union defined as no pain or tenderness at the site, and strong enough to allow normal activities.)	12 months
Secondary	Range of Motion	The Range of Motion (total shoulder motion, active and passive) of the affected and contralateral (right and left) upper arm will be measured.	12 months
Secondary	EQ-5D-5L	EQ-5D-5L Health Questionnaire is completed by the patient and assesses his/her general health status. The EQ-5D-5L is used to derive a quality of life index used for health economics considerations.	12 months
Secondary	Radiographic Findings	Postoperative Radiographic Evaluation collects radiographic parameters like bridging callus, visible fracture line, device fracture, device loosening and union status (AP, lateral, and auxiliary view).	12 months
Secondary	Adverse Events	Adverse Event Report is completed as needed for each complication which is noted.	12 months