Clinical trial NCT03339570: Orthopaedic Treatment Proximal Humeral Fractures
Official title: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Proximal Humeral Fracture
Lead sponsor: Hospital General Universitario Gregorio Marañon
Sponsor class: OTHER
First posted: 2017-11-13
Enrollment: 20
Sex: ALL
Minimum age (years): 75
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Elderly population suffering proximal humeral fractures

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* 75 years or older.
* 3 or 4 parts fracture (Neer's Classification).

Exclusion Criteria:

* Comorbilities affecting to functional recovery.
* Fractures associating shoulder dislocation.
* Open fractures including neurovascular damage.
* Polytraumatized patients

Primary outcomes:
measure: Constant Scale Evaluation at 3 Months and 12 Months From the Date of Trauma
timeFrame: 1 year
measure: ASES Scale Evaluation
timeFrame: 12 months
measure: DASH Scale Evaluation
timeFrame: 12 months
measure: VAS Scale Evaluation
timeFrame: 12 months
Secondary outcomes:
measure: Statistical Analysis of Changes in Numeric Values for the Constant Scale in the Context of a Cohort Study
timeFrame: 12 months
measure: Development of Osteonecrosis or Lack of Consolidation
timeFrame: 1 year
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Servicio de Cirugía Ortopédica y Traumatología, HGU Gregorio Maranon
Study officials:
affiliation: HGU Gregorio Marañon
name: Mikel Aburto, MD
role: PRINCIPAL_INVESTIGATOR
References: