Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Orthopaedic Treatment Proximal Humeral Fractures

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03339570
Recruitment Status : Recruiting
First Posted : November 13, 2017
Last Update Posted : February 19, 2020
Sponsor:
Information provided by (Responsible Party):
Mikel Aburto, Hospital General Universitario Gregorio Marañon

Brief Summary:
Prospective non-randomized, open, unicentric clinical trial 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.

Condition or disease
Proximal Humeral Fracture

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 and Constant score) at the time of one, three, six 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 studies the effect of this intervention.

Layout table for study information
Study Type : Observational
Estimated Enrollment : 20 participants
Observational Model: Cohort
Time Perspective: Prospective
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
Actual Study Start Date : March 15, 2018
Estimated Primary Completion Date : August 16, 2020
Estimated Study Completion Date : November 1, 2020

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. Changes in numeric values for the Constant shoulder function scale applied to 20 patients with fractures of 3 and 4 parts of proximal humerus (according to Neer's Classification) evaluated at the time of 1,3,6 and 12 months from the date of the trauma. [ Time Frame: 1 year ]
  2. Changes in numeric values for the ASES shoulder function scale applied to 20 patients with fractures of 3 and 4 parts of proximal humerus (according to Neer's Classification) evaluated at the time of 1,3,6 and 12 months from the date of the trauma. [ Time Frame: 1 year ]

Secondary Outcome Measures :
  1. Statistical analysis of changes in numeric values for the Constant and ASES shoulder function scales in the context of a cohort study [ Time Frame: 1 year ]
    To compare the results of these scales in the prospective cohort (non-surgical cohort) with the results already obtained in a historical cohort of 20 patients who were operated on by this same pathology in our hospital

  2. Assess possible complications related to the treatment [ Time Frame: 1 year ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   75 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Elder population suffering proximal humeral fractures
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • comorbilities affecting to functional recovery.
  • fractures/dislocation of shoulder
  • open fractures including neurovascular damage.
  • polytraumatized patients

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03339570


Contacts
Layout table for location contacts
Contact: Mikel Aburto, MD 34606034007 mikelaburto@hotmail.com
Contact: Carlos Alvarez, MD 34606034007 calvargon@gmail.com

Locations
Layout table for location information
Spain
Servicio de Cirugía Ortopédica y Traumatología, HGU Gregorio Maranon Recruiting
Madrid, Spain, 28007
Contact: Mikel Aburto, MD    34914269801    mikelaburto@hotmail.com   
Principal Investigator: Mikel Aburto, MD         
Sponsors and Collaborators
Mikel Aburto
Investigators
Layout table for investigator information
Principal Investigator: Mikel Aburto, MD HGU Gregorio Marañon
Layout table for additonal information
Responsible Party: Mikel Aburto, OS head of unit, Hospital General Universitario Gregorio Marañon
ClinicalTrials.gov Identifier: NCT03339570    
Other Study ID Numbers: SCIARPA 3/4
First Posted: November 13, 2017    Key Record Dates
Last Update Posted: February 19, 2020
Last Verified: February 2020

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Fractures, Bone
Humeral Fractures
Shoulder Fractures
Wounds and Injuries
Arm Injuries
Shoulder Injuries