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Evidence Based Algorithm for Proximal Humerus Fractures

C

Cantonal Hospital of St. Gallen

Status

Completed

Conditions

Proximal Humeral Fracture

Treatments

Procedure: Therapy of proximal humeral fractures (irrespective conservative or operative)

Study type

Observational

Funder types

Other

Identifiers

NCT03464578
ProxHumFx

Details and patient eligibility

About

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.

Enrollment

143 patients

Sex

All

Volunteers

No Healthy Volunteers

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.

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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