Targon PH+ Follow-Up

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-03-31

Study Completion Date

2019-04-30

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

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Detailed Description

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Conditions

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Shoulder Fractures

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* older than 60 years of age
* written and signed patient consent

Exclusion Criteria

* 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)

Minimum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No