Clinical Trial: Targon PH+ Follow-Up

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Observational

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 Summary:
Sponsor: Aesculap AG

Current Primary Outcome: 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: Same as current

Current Secondary Outcome:

  • 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: Same as current

Information By: Aesculap AG

Dates:
Date Received: June 10, 2016
Date Started: March 2016
Date Completion: February 2019
Last Updated: July 18, 2016
Last Verified: July 2016