Targon PH+ Follow-Up
Prospective Cohort Study of Proximal Humeral Fractures Treated With Targon® PH+
1 other identifier
observational
50
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Mar 2016
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2016
CompletedFirst Submitted
Initial submission to the registry
June 10, 2016
CompletedFirst Posted
Study publicly available on registry
July 19, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2019
CompletedJune 7, 2019
June 1, 2019
3.1 years
June 10, 2016
June 6, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (5)
Level of pain
3, 12 and 24 months
Patient satisfaction
24 months
Shoulder Function
12 months, 24 months
Radiological outcome (only if it could be raised in clinical standard)
24 months
Adverse Events
24 months
Eligibility Criteria
adult patients
You may qualify if:
- older than 60 years of age
- written and signed patient consent
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Aesculap AGlead
Study Sites (1)
Klinikum Nürnberg Süd
Nuremberg, Bavaria, 90471, Germany
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Hermann Josef Bail, Prof. Dr.
Klinikum Nürnberg Süd
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 10, 2016
First Posted
July 19, 2016
Study Start
March 1, 2016
Primary Completion
April 1, 2019
Study Completion
April 1, 2019
Last Updated
June 7, 2019
Record last verified: 2019-06
Data Sharing
- IPD Sharing
- Will not share