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Completed

NCT Number: NCT02836366

Targon PH+ Follow-Up

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

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Key information

Conditions

Shoulder Fractures Fractures, Bone Shoulder Injuries Wounds and Injuries

Age range

60 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Klinikum Nürnberg Süd

Nuremberg, Bavaria, 90471, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Aesculap AG

Industry

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2019
Study completion
2019
First posted
Jul 19, 2016
Registry last updated
Jun 7, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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