Targon PH+ Follow-Up

Aesculap

Status: Completed

Conditions: Shoulder Fractures

Study type: Observational

Funder types: Industry

Identifiers

NCT02836366

AAG-O-H-1536

Details and patient eligibility

About

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

Enrollment: 50 patients

Sex: All

Ages: 60+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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)