Orthopaedic Treatment Proximal Humeral Fractures

Proximal Humeral Fracture Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03339570
• Other study ID #: SCIARPA 3/4
• Status: Completed
• Start date: November 15, 2017
• Est. completion date: November 1, 2020

Study information

• Verified date: October 2021
• Source: Hospital General Universitario Gregorio Marañon
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: November 1, 2020
• Est. primary completion date: June 16, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 75 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Fractures, Bone
• Humeral Fractures
• Proximal Humeral Fracture
• Shoulder Fractures

Intervention

Procedure:
• 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.

Locations

Country	Name	City	State
Spain	Servicio de Cirugía Ortopédica y Traumatología, HGU Gregorio Maranon	Madrid

Sponsors (1)

Lead Sponsor	Collaborator
Mikel Aburto

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Constant Scale Evaluation at 3 Months and 12 Months From the Date of Trauma	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 3 months and 12 months from the date of the trauma.; The Constant scale, also known as the ConstantMurley score, is one of the most widely used instruments to evaluate the shoulder. It was originally published in 1987 by the European Society of Shoulder and Elbow Surgeons (SECEC) as a method to compare function of the shoulder before and after a treatment. It is a system that combines the physical examination (65 points) with the subjective evaluation of the patient (35 points). The maximum score is 100 points, being from 90 to 100 excellent, from 80 to 89 good, from 70 to 79 average, and less than 70 poor.	1 year
Primary	ASES Scale Evaluation	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 3 months and 12 months from the date of the trauma.; ASES evaluation comprises a subjective part completed by the patient and an objective part performed by doctor. The subjective includes questions about pain, symptoms of instability, and activities of daily living.; The final score includes two subscales: Pain subscale 0-50 ASES points.; Function/disability subscale 0-50 ASES points. Total score 0-100 ASES points, being 0 = worse pain and functional loss/disability	12 months
Primary	DASH Scale Evaluation	Changes in numeric values for the DASH 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 3 months and 12 months from the date of the trauma.; DASH scale consists of 30 questions. In addition, there are two optional modules, each containing four questions, which are used to assess the symptoms and function of athletes, artists and other workers whose functional demands exceed those assessed by the DASH questionnaire.; Calculating the final score is relatively complicated. To calculate the score it is necessary that at least 27 of the 30 questions have been answered. The final score is obtained by calculating the arithmetic mean of the answered questions, subtracting 1 and multiplying by 25. This calculation provides a score between 0 and 100, with the greater the disability the higher the score obtained, and considering variations with clinical significance those that exceed the 10 points.	12 months
Primary	VAS Scale Evaluation	Changes in numeric values for the Changes in numeric values for the VAS 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 3 months and 12 months from the date of the trauma.; VAS is defined as a one-dimensional scale for the subjective assessment of pain by the patient. It consists of a straight line (usually 10 centimeters -100 millimeters) in whose limits the most extreme degrees of pain intensity are located, considering a score of 0 points for the lowest degree or absence of pain (usually referred by the patient as "no pain") and 100 points for the highest grade (often referred to as "worst bearable" or "worst pain imaginable").; The final score (from 0 to 100 points) is obtained by measuring the distance in millimeters between the lower end (score of 0 points) and the mark indicated by the patient along the line.	12 months
Secondary	Statistical Analysis of Changes in Numeric Values for the Constant Scale in the Context of a Cohort Study	To compare the results of Constant scale at 12 months 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.; The Constant scale, also known as the ConstantMurley score, is one of the most widely used instruments to evaluate the shoulder. It was originally published in 1987 by the European Society of Shoulder and Elbow Surgeons (SECEC) as a method to compare function of the shoulder before and after a treatment. It is a system that combines the physical examination (65 points) with the subjective evaluation of the patient (35 points). The maximum score is 100 points, being from 90 to 100 excellent, from 80 to 89 good, from 70 to 79 average, and less than 70 poor.	12 months
Secondary	Development of Osteonecrosis or Lack of Consolidation	Collect possible complications derived from non-surgical treatment in the prospective cohort, such as humeral head osteonecrosis or lack of consolidation.	1 year