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Effectiveness Between Two Surgical Techniques for Reconstruction of Humeral Proximal Extremity Fractures

Primary Purpose

A02.835.232.087.090.400.400

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Hemiarthroplasty
reverse arthroplasty
Sponsored by
Carlos Alvarez
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for A02.835.232.087.090.400.400 focused on measuring Fracture-luxation, humeral proximal extremity, Hemiarthroplasty, reverse Arthroplasty

Eligibility Criteria

70 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients with humeral proximal extremity fracture or fracture luxation in three or four fragments of Neer's classification.
  • Patient 70 years older
  • Signed informed consent.

Exclusion Criteria:

  • Any condition to make worse the functional recovery or avoid the patient collaboration with the rehabilitation program ( cognitive disability, neurological pathology…)

    • Glenohumeral osteoarthritis
    • Inflammatory arthropathies
    • Previous cuff arthropatyy
    • High surgical or anesthesia risk
    • Any disease or condition that the investigator finds decisive for exclusion.

Sites / Locations

  • Hospital General Universitario Gregorio Marañon

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Hemiarthroplasty Global Fx(DePuy)

reverse arthroplasty Delta Xtent(DePuy)

Arm Description

in this technique the prosthesis is implanted in similar approach to shoulder anatomy

In this technique the prosthesis is implanted in the inverse mode of shoulder anatomy

Outcomes

Primary Outcome Measures

Effectiveness Will be Measured for AMERICAN SHOULDER AND ELBOW (ASES) Score
changes en ASES (AMERICAN SHOULDER AND ELBOW) score will be measured. The ASES questionnaire is composed of both a physician-rated component and a patient-reported component. The patient questions focus on joint pain, instability, and activities of daily living. This questionary includes a section on pain (7 items) and a section on activities of daily living (10 items). Scores range from 0 to 100 with a score of 0 indicating a worse shoulder condition and 100 indicating a better shoulder condition.
Effectiveness Will be Measured for Constant Score
changes in Constant score will be measured. The Constant-Murley score (CMS) is a 100-points scale composed of a number of individual parameters. These parameters define the level of pain and the ability to carry out the normal daily activities of the patient. The Constant-Murley score was introduced to determine the functionality after the treatment of a shoulder injury. The test is divided into four subscales: pain (15 points), activities of daily living (20 points), strength (25 points) and range of motion: forward elevation, external rotation, abduction and internal rotation of the shoulder (40 points). The higher the score, the higher the quality of the function.
Effectiveness Will be Measured for DASH (Disabilities of the Arm, Shoulder and Hand) Score
changes in DASH (Disabilities of the Arm, Shoulder and Hand) score will be measured. The Disabilities of the Arm, Shoulder and Hand (DASH) outcome measure is a 30-item, self-report questionnaire designed to assess the patient's health status during the previous week. The items enquire about the degree of difficulty in performing different physical activities because of arm, shoulder and hand problems (21 items), the severity of each of the symptoms of pain, activity-related pain, tingling, weakness and stiffness (five items) and the impact of the problem on social functioning, work, sleep and self-image (four items). Each item has five response options. The scores are then used to calculate a scale score ranging from 0 (no disability) to 100 (most severe disability)

Secondary Outcome Measures

Full Information

First Posted
February 6, 2014
Last Updated
April 1, 2020
Sponsor
Carlos Alvarez
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1. Study Identification

Unique Protocol Identification Number
NCT02075476
Brief Title
Effectiveness Between Two Surgical Techniques for Reconstruction of Humeral Proximal Extremity Fractures
Official Title
Prospective, Randomized and Double Blind Study of Parallels Groups for Evaluating the Effectiveness Between Two Surgical Techniques for Reconstruction of Humeral Proximal Extremity Fractures in Three or Four Fragments
Study Type
Interventional

2. Study Status

Record Verification Date
April 2020
Overall Recruitment Status
Completed
Study Start Date
May 2013 (Actual)
Primary Completion Date
August 5, 2015 (Actual)
Study Completion Date
August 6, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Carlos Alvarez

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to evaluate the effectiveness and safety of two surgical techniques for the treatments of proximal extremity humeral fractures and fractures luxation in three o four fragments of Neer's classification.
Detailed Description
Proximal extremity humeral fractures present high prevalence. It's estimated about 10% of all fractures. Their incidence is 6,6/1000 people-year and this amount increases from 40 years old. The majority are successfully treated with immobilization and rehabilitation. The surgical treatment is recommended in case of displacement. In elderly population with fractures types three or four of Neer's classification there is no consensus on which technique is the best surgical option. Classically hemiarthroplasty has been widely performed as a reconstruction method but its outcomes in old patients are unclear due to the bad bone quality and joint features. Recently some authors recommend the reverse arthroplasty in patients over 70 years old . The aim of this study is to compare the results between Hemiarthroplasty and reverse arthroplasty in patients over 70 years old. As far as the investigators are concerned there's no published studies like this.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
A02.835.232.087.090.400.400
Keywords
Fracture-luxation, humeral proximal extremity, Hemiarthroplasty, reverse Arthroplasty

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Hemiarthroplasty Global Fx(DePuy)
Arm Type
Active Comparator
Arm Description
in this technique the prosthesis is implanted in similar approach to shoulder anatomy
Arm Title
reverse arthroplasty Delta Xtent(DePuy)
Arm Type
Experimental
Arm Description
In this technique the prosthesis is implanted in the inverse mode of shoulder anatomy
Intervention Type
Procedure
Intervention Name(s)
Hemiarthroplasty
Intervention Type
Procedure
Intervention Name(s)
reverse arthroplasty
Primary Outcome Measure Information:
Title
Effectiveness Will be Measured for AMERICAN SHOULDER AND ELBOW (ASES) Score
Description
changes en ASES (AMERICAN SHOULDER AND ELBOW) score will be measured. The ASES questionnaire is composed of both a physician-rated component and a patient-reported component. The patient questions focus on joint pain, instability, and activities of daily living. This questionary includes a section on pain (7 items) and a section on activities of daily living (10 items). Scores range from 0 to 100 with a score of 0 indicating a worse shoulder condition and 100 indicating a better shoulder condition.
Time Frame
36 months
Title
Effectiveness Will be Measured for Constant Score
Description
changes in Constant score will be measured. The Constant-Murley score (CMS) is a 100-points scale composed of a number of individual parameters. These parameters define the level of pain and the ability to carry out the normal daily activities of the patient. The Constant-Murley score was introduced to determine the functionality after the treatment of a shoulder injury. The test is divided into four subscales: pain (15 points), activities of daily living (20 points), strength (25 points) and range of motion: forward elevation, external rotation, abduction and internal rotation of the shoulder (40 points). The higher the score, the higher the quality of the function.
Time Frame
36 months
Title
Effectiveness Will be Measured for DASH (Disabilities of the Arm, Shoulder and Hand) Score
Description
changes in DASH (Disabilities of the Arm, Shoulder and Hand) score will be measured. The Disabilities of the Arm, Shoulder and Hand (DASH) outcome measure is a 30-item, self-report questionnaire designed to assess the patient's health status during the previous week. The items enquire about the degree of difficulty in performing different physical activities because of arm, shoulder and hand problems (21 items), the severity of each of the symptoms of pain, activity-related pain, tingling, weakness and stiffness (five items) and the impact of the problem on social functioning, work, sleep and self-image (four items). Each item has five response options. The scores are then used to calculate a scale score ranging from 0 (no disability) to 100 (most severe disability)
Time Frame
36 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients with humeral proximal extremity fracture or fracture luxation in three or four fragments of Neer's classification. Patient 70 years older Signed informed consent. Exclusion Criteria: Any condition to make worse the functional recovery or avoid the patient collaboration with the rehabilitation program ( cognitive disability, neurological pathology…) Glenohumeral osteoarthritis Inflammatory arthropathies Previous cuff arthropatyy High surgical or anesthesia risk Any disease or condition that the investigator finds decisive for exclusion.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Carlos Alvarez, MD
Organizational Affiliation
Hospital General Universitario Gregorio Marañon
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital General Universitario Gregorio Marañon
City
Madrid
ZIP/Postal Code
28007
Country
Spain

12. IPD Sharing Statement

Citations:
PubMed Identifier
35727196
Citation
Handoll HH, Elliott J, Thillemann TM, Aluko P, Brorson S. Interventions for treating proximal humeral fractures in adults. Cochrane Database Syst Rev. 2022 Jun 21;6(6):CD000434. doi: 10.1002/14651858.CD000434.pub5.
Results Reference
derived

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Effectiveness Between Two Surgical Techniques for Reconstruction of Humeral Proximal Extremity Fractures

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