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.
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.
Study Type
OBSERVATIONAL
Enrollment
100
Patient with either a proximal humeral fracture or humeral shaft fracture requiring surgical intervention and be eligible for fixation by intramedullary nailing.
University of Texas Health Science Center at San Antonio
San Antonio, Texas, United States
RECRUITINGUZ Leuven - Traumatology Department
Leuven, Belgium
RECRUITINGHospital de la Santa Creu i Sant Pau
Barcelona, Spain
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.)
Time frame: 12 months
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.
Time frame: 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.
Time frame: 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).
Time frame: 12 months
Adverse Events
Adverse Event Report is completed as needed for each complication which is noted.
Time frame: 12 months
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General Foundation of the University of Valladolid
Valladolid, Spain
RECRUITINGKantonsspital Frauenfeld
Frauenfeld, Thurgau, Switzerland
RECRUITING