Affixus Natural Nail System Humeral Nail PMCF

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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)

Conditions
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Humeral Fractures, Proximal, Humeral Fractures

Intervention / Treatment
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* Device: Affixus Natural Nail System


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment Group<br>Subject target population suffers from fractures or osteotomies of the humerus which require temporary fixation and stabilization. | Device: Affixus Natural Nail System<br>* Intramedullary nailing designed for fixation and stabilization of fractures or osteotomies of the humerus. Nails are comprised of proximal and antegrade/retrograde.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 
| Adverse Events | Adverse Event Report is completed as needed for each complication which is noted. | 12 months |