Orthopaedic Treatment Proximal Humeral Fractures

NCT03339570 | Completed Results

• 1 other identifier: SCIARPA 3/4
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Proximal Humeral Fracture

Outcome Measures

Primary Outcomes (4)

• 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

• 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: 1. Pain subscale 0-50 ASES points. 2. Function/disability subscale 0-50 ASES points. Total score 0-100 ASES points, being 0 = worse pain and functional loss/disability

  12 months

• 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

• 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 Outcomes (2)

• Statistical Analysis of Changes in Numeric Values for the Constant Scale in the Context of a Cohort Study

  12 months

• Development of Osteonecrosis or Lack of Consolidation

  1 year

Study Arms (1)

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.

Procedure: Orthopedic treatment for a proximal humeral fracture

Interventions

Orthopedic treatment for a proximal humeral fracture PROCEDURE

Orthopedic treatment consisting in inmobilization of the arm in a sling for the first three weeks, followed by physical therapy.

Orthopedic treatment

Eligibility Criteria

• Age: 75 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Elderly population suffering proximal humeral fractures

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Mikel Aburto: lead

Study Sites (1)

Servicio de Cirugía Ortopédica y Traumatología, HGU Gregorio Maranon

Madrid, 28007, Spain

Location

MeSH Terms

Conditions

Shoulder Fractures

Condition Hierarchy (Ancestors)

Fractures, Bone; Wounds and Injuries; Shoulder Injuries

Results Point of Contact

• Title: Dr. Mikel Aburto
• Organization: Hospital Gregorio Maranon

mikelaburto@hotmail.com

34915868000

Study Officials

• Mikel Aburto, MD

  HGU Gregorio Marañon

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: OS head of unit

Study Record Dates

• First Submitted: September 12, 2017
• First Posted: November 13, 2017
• Study Start: November 15, 2017
• Primary Completion: June 16, 2019
• Study Completion: November 1, 2020
• Last Updated: November 16, 2021
• Results First Posted: November 16, 2021

Record last verified: 2021-10

Locations

ES (1)