Targon PH+ Follow-Up

Study Overview
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Brief Summary
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With this study results of the Targon® PH+ nail, developed for the treatment of humeral head fractures, will be investigated clinically, radiological evaluation is optional. The primary objective of this study is to examine the effect of a plating treatment on the speed of recovery of functional capacity in adult patients. Secondary aims are to examine the level of pain, patient satisfaction, shoulder function, quality of life, radiological evaluation and complications. Targon PH+ is CE certified. The study is a non-interventional cohort study sponsored by Aesculap

Official Title
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Prospective Cohort Study of Proximal Humeral Fractures Treated With Targon® PH+

Conditions
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Shoulder Fractures

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: - patients with a three- or four-fragment-fracture of the proximal humerus, with dislocation on X-ray older than 60 years of age written and signed patient consent Exclusion Criteria: - Fractures more than 14 days old multiple comorbidity multitrauma (Injury Severity Score > 15) prev. surgery on the injured shoulder severely deranged function caused by a previous disease head-split proximal humerus fracture combined humerus head and shaft fractures pseudarthroses crushed head cap of the humerus head (AO 11 C3 fractures) isolated avulsion fracture of a tuberosity unwillingness or inability to follow protocol instructions and study requirements (follow-up visits) no signed informed consent treatment not in line with Instructions for Use (IfU)

Ages Eligible for Study
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Minimum Age: 60 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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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Functional Capacity | The DASH score (Disabilities of the Arm, Shoulder, and Hand) will be used to determine the recovery of functional capacity. It provides a summary of the responses on a scale of 0 (no disability) to 100 (severe disability) | 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Level of pain | 10-point Visual Analogue Scale (VAS) from no pain (0) to most extreme pain imaginable (10) | 3, 12 and 24 months | 
| Patient satisfaction | 4 point scale: very satisfied, satisfied, unsatisfied, very unsatisfied | 24 months | 
| Shoulder Function | Shoulder function outcome is measured with the Constant-Murley score, this score system combines shoulder function tests (65 points) with a subjective evaluation of the patients (35 points) including activities of daily living, level of work | 12 months, 24 months | 
| Radiological outcome (only if it could be raised in clinical standard) | The X-rays are examined regarding adverse events as screw perforation, screw breakage, cut-out, re-dislocation of the fracture | 24 months | 
| Adverse Events | Rate of Adverse Events, for example secondary interventions (revisions) that occur within the follow-up period | 24 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Proximal humerus, Fracture, Nailing