Targon PH+ Follow-Up

June 6, 2019 updated by: Aesculap AG

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

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

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • Bayern
      • Nürnberg, Bayern, Germany, 90471
        • Klinikum Nürnberg Süd

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

60 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

adult patients

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Functional Capacity
Time Frame: 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)
24 months

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Aesculap AG

Investigators

  • Principal Investigator: Hermann Josef Bail, Prof. Dr., Klinikum Nürnberg Süd

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

March 1, 2016

Primary Completion (ACTUAL)

April 1, 2019

Study Completion (ACTUAL)

April 1, 2019

Study Registration Dates

First Submitted

June 10, 2016

First Submitted That Met QC Criteria

July 18, 2016

First Posted (ESTIMATE)

July 19, 2016

Study Record Updates

Last Update Posted (ACTUAL)

June 7, 2019

Last Update Submitted That Met QC Criteria

June 6, 2019

Last Verified

June 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AAG-O-H-1536

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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