Targon PH+ Follow-Up

Shoulder Fractures Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02836366
• Other study ID #: AAG-O-H-1536
• Status: Completed
• Start date: March 2016
• Est. completion date: April 2019

Study information

• Verified date: June 2019
• Source: Aesculap AG
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: April 2019
• Est. primary completion date: April 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Fractures, Bone
• Shoulder Fractures

Locations

Country	Name	City	State
Germany	Klinikum Nürnberg Süd	Nürnberg	Bayern

Sponsors (1)

Lead Sponsor	Collaborator
Aesculap AG

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Level of pain	10-point Visual Analogue Scale (VAS) from no pain (0) to most extreme pain imaginable (10)	3, 12 and 24 months
Secondary	Patient satisfaction	4 point scale: very satisfied, satisfied, unsatisfied, very unsatisfied	24 months
Secondary	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
Secondary	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
Secondary	Adverse Events	Rate of Adverse Events, for example secondary interventions (revisions) that occur within the follow-up period	24 months