Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
20 participants
OBSERVATIONAL
2017-11-15
2020-11-01
Brief Summary
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Detailed Description
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* 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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Orthopedic treatment
This is the prospective cohort which includes 20 patients presenting three-four proximal humeral fracture who were treated non-surgically and followed prospectively during 12 months.
Orthopedic treatment for a proximal humeral fracture
Orthopedic treatment consisting in inmobilization of the arm in a sling for the first three weeks, followed by physical therapy.
Interventions
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Orthopedic treatment for a proximal humeral fracture
Orthopedic treatment consisting in inmobilization of the arm in a sling for the first three weeks, followed by physical therapy.
Eligibility Criteria
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Inclusion Criteria
* 3 or 4 parts fracture (Neer's Classification).
Exclusion Criteria
* Fractures associating shoulder dislocation.
* Open fractures including neurovascular damage.
* Polytraumatized patients
75 Years
ALL
No
Sponsors
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Mikel Aburto
OTHER
Responsible Party
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Mikel Aburto
OS head of unit
Principal Investigators
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Mikel Aburto, MD
Role: PRINCIPAL_INVESTIGATOR
HGU Gregorio Marañon
Locations
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Servicio de Cirugía Ortopédica y Traumatología, HGU Gregorio Maranon
Madrid, , Spain
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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SCIARPA 3/4
Identifier Type: -
Identifier Source: org_study_id