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Orthopaedic Treatment of Proximal Humeral Fractures With Sling. Prospective , Non-randomized Open Study to Compare Two Treatments Effectiveness in the Management of Three-four Part (Neer's Classification) of Proximal Humeral Fractures
Prospective non-randomized, open, unicentric observational study to compare two different treatments for Three-four parts fractures of proximal humerus (Neer's Classification) in elderly patients (over 75 years old). Both technics are: Sling inmobilization and shoulder arthroplasty.
The investigators propose an observational study that aims to assess: * Primarily, the functional results of a cohort of 20 pacients presenting fractures of 3 and 4 parts of proximal humerus (according to (Neer's Classification) that will be treated orthopedically (this is, non-surgically). This patients will be recruited in the emergency room of our center, and after being diagnosed of their fracture, will be treated with a sling for three weeks and subsequent rehabilitation treatment. Our intention is to assess the function of the injured shoulder using functional scales (ASES, DASH and Constant score, and VAS scale) at the time of three and twelve months from the date of the trauma. * Secondly the investigators want to compare the results obtained in this cohort with the results of a historical cohort of patients operated in our center with the same type of fracture. Both types of treatment (non-surgical and shoulder prosthesis) are valid for this type of fracture, and endorsed by the scientific literature. The investigators consider this to be an observational study since it assigns a single cohort of patients a single treatment (ie non-surgical treatment). The conservative treatment for this fractures is part of routine medical care, and the object of this study is to evaluate the effect of this intervention.
Age
75 - No limit years
Sex
ALL
Healthy Volunteers
No
Servicio de Cirugía Ortopédica y Traumatología, HGU Gregorio Maranon
Madrid, Spain
Start Date
November 15, 2017
Primary Completion Date
June 16, 2019
Completion Date
November 1, 2020
Last Updated
November 16, 2021
20
ACTUAL participants
Orthopedic treatment for a proximal humeral fracture
PROCEDURE
Lead Sponsor
Mikel Aburto
NCT03328650
NCT06133920
Data Source & Attribution
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View ClinicalTrials.gov Terms and ConditionsNCT03626038