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OpenTrials
Completed

NCT Number: NCT03464578

Evidence Based Algorithm for Proximal Humerus Fractures

Proximal humerus fractures are particularly frequent injuries and represent 6% of all fractures with an overall incidence of 63/100.000 in human. The goal is to assess our institutional evidence based algorithm for treatment of proximal humeral fractures.

Objective(s):

1. Test the algorithm in terms of clinical applicability and clinical outcome 2. Compare general outcome and general complication/revision rate to the literature.

Inclusion / Exclusion criteria: Inclusion: All patients with an acute proximal humeral fracture (not older than 48 hours) admitted to our institution later than 1.1.2014. Exclusion: Multilevel and pathological fractures are excluded.

Terminally ill patients and those not being able, or willing to sing the informed consent.

Project Centre(s): Single-centre.

Statistical Considerations: Standard descriptive statistics will be performed using R-statistics program. Considering the population of 160 patients, we will be able to detect differences in proportions as low as 0.15 with power 82% and alpha = 0.05.

Other methodological Considerations: Terms applicability of a treatment protocol and adhesion to protocol are not well defined for decision making in orthopaedic surgery.

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Key information

Conditions

Proximal Humeral Fracture Fractures, Bone Shoulder Fractures Shoulder Injuries Wounds and Injuries

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Orthopaedic Surgery and Traumatology

Sankt Gallen, 9007, Switzerland

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Acute traumatic proximal humeral fracture
  • Signed informed consent

Exclusion criteria

  • Fracture older than 48 hours at admission
  • Multilevel fractures of the humerus
  • Pathological fractures
  • Terminally ill patients.

Treatment and study plan

Therapy of proximal humeral fractures (irrespective conservative or operative)

Procedure

Primary outcomes

  1. Constant Score

    Time frame: One year

    Point 0-100

Sponsors and collaborators

Lead sponsor

Cantonal Hospital of St. Gallen

Other

Registry information

Official study title

Evidence Based Algorithm to Treat Patients With Proximal Humerus Fractures - A Prospective Study With Early Clinical and Overall Performance Results

Important dates

Study start
2014
Primary completion
2020
Study completion
2020
First posted
Mar 14, 2018
Registry last updated
Aug 16, 2021

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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