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Targon PH+ Follow-Up

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02836366
Recruitment Status : Completed
First Posted : July 19, 2016
Last Update Posted : June 7, 2019
Sponsor:
Information provided by (Responsible Party):
Aesculap AG

Tracking Information
First Submitted Date June 10, 2016
First Posted Date July 19, 2016
Last Update Posted Date June 7, 2019
Actual Study Start Date March 2016
Actual Primary Completion Date April 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: July 18, 2016)
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)
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: July 18, 2016)
  • 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)
  • Patient satisfaction [ Time Frame: 24 months ]
    4 point scale: very satisfied, satisfied, unsatisfied, very unsatisfied
  • 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
  • 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
  • Adverse Events [ Time Frame: 24 months ]
    Rate of Adverse Events, for example secondary interventions (revisions) that occur within the follow-up period
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Targon PH+ Follow-Up
Official Title Prospective Cohort Study of Proximal Humeral Fractures Treated With Targon® PH+
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 Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population adult patients
Condition Shoulder Fractures
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: June 6, 2019)
50
Original Estimated Enrollment
 (submitted: July 18, 2016)
102
Actual Study Completion Date April 2019
Actual Primary Completion Date April 2019   (Final data collection date for primary outcome measure)
Eligibility 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)
Sex/Gender
Sexes Eligible for Study: All
Ages 60 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Germany
Removed Location Countries  
 
Administrative Information
NCT Number NCT02836366
Other Study ID Numbers AAG-O-H-1536
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Aesculap AG
Study Sponsor Aesculap AG
Collaborators Not Provided
Investigators
Principal Investigator: Hermann Josef Bail, Prof. Dr. Klinikum Nürnberg Süd
PRS Account Aesculap AG
Verification Date June 2019