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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

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


Condition or disease
Shoulder Fractures

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Study Type : Observational
Actual Enrollment : 50 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prospective Cohort Study of Proximal Humeral Fractures Treated With Targon® PH+
Actual Study Start Date : March 2016
Actual Primary Completion Date : April 2019
Actual Study Completion Date : April 2019

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. 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)


Secondary Outcome Measures :
  1. 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)

  2. Patient satisfaction [ Time Frame: 24 months ]
    4 point scale: very satisfied, satisfied, unsatisfied, very unsatisfied

  3. 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

  4. 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

  5. Adverse Events [ Time Frame: 24 months ]
    Rate of Adverse Events, for example secondary interventions (revisions) that occur within the follow-up period



Information from the National Library of Medicine

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Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
adult patients
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02836366


Locations
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Germany
Klinikum Nürnberg Süd
Nürnberg, Bayern, Germany, 90471
Sponsors and Collaborators
Aesculap AG
Investigators
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Principal Investigator: Hermann Josef Bail, Prof. Dr. Klinikum Nürnberg Süd
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Responsible Party: Aesculap AG
ClinicalTrials.gov Identifier: NCT02836366    
Other Study ID Numbers: AAG-O-H-1536
First Posted: July 19, 2016    Key Record Dates
Last Update Posted: June 7, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Aesculap AG:
Proximal humerus
Fracture
Nailing
Additional relevant MeSH terms:
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Fractures, Bone
Shoulder Fractures
Wounds and Injuries
Shoulder Injuries