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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
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| 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 |
| 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 |
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Inclusion Criteria: - patients with a three- or four-fragment-fracture of the proximal humerus, with dislocation on X-ray
Exclusion Criteria: - Fractures more than 14 days old
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adult patients
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| Name | Affiliation | Role |
|---|---|---|
| Hermann Josef Bail, Prof. Dr. | Klinikum Nürnberg Süd | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Klinikum Nürnberg Süd | Nuremberg | Bavaria | 90471 | Germany |
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| ID | Term |
|---|---|
| D012784 | Shoulder Fractures |
| D050723 | Fractures, Bone |
| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
| D000070599 | Shoulder Injuries |
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| 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 |