Targon PH+ Follow-Up

Completed

• Conditions: Shoulder Fractures

• Registration Number: NCT02836366
• Lead Sponsor: Aesculap AG

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2016-03
• Study First Submitted: 2016-06-10
• Study First Submitted QC: 2016-07-18
• Study First Posted: 2016-07-19
• Primary Completion: 2019-04
• Study Completion: 2019-04
• Status Verified: 2019-06
• Last Update Submitted: 2019-06-06
• Last Update Posted: 2019-06-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Functional Capacity	24 months	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)

Secondary Outcome Measures

Name	Time	Method
Level of pain	3, 12 and 24 months	10-point Visual Analogue Scale (VAS) from no pain (0) to most extreme pain imaginable (10)
Patient satisfaction	24 months	4 point scale: very satisfied, satisfied, unsatisfied, very unsatisfied
Radiological outcome (only if it could be raised in clinical standard)	24 months	The X-rays are examined regarding adverse events as screw perforation, screw breakage, cut-out, re-dislocation of the fracture
Adverse Events	24 months	Rate of Adverse Events, for example secondary interventions (revisions) that occur within the follow-up period
Shoulder Function	12 months, 24 months	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

Trial Locations

Locations (1)

Klinikum Nürnberg Süd; 🇩🇪 Nürnberg, Bayern, Germany