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

NCT02075476 | Completed Results

• 1 other identifier: FRALUX-34
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

A02.835.232.087.090.400.400

Keywords

Fracture-luxation; humeral proximal extremity; Hemiarthroplasty; reverse Arthroplasty

Outcome Measures

Primary Outcomes (3)

• 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.

  36 months

• 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.

  36 months

• 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)

  36 months

Study Arms (2)

Hemiarthroplasty Global Fx(DePuy)

ACTIVE COMPARATOR

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

Procedure: Hemiarthroplasty

reverse arthroplasty Delta Xtent(DePuy)

EXPERIMENTAL

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

Procedure: reverse arthroplasty

Interventions

Hemiarthroplasty PROCEDURE

Hemiarthroplasty Global Fx(DePuy)

reverse arthroplasty PROCEDURE

reverse arthroplasty Delta Xtent(DePuy)

Eligibility Criteria

• Age: 70 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Carlos Alvarez: lead

Study Sites (1)

Hospital General Universitario Gregorio Marañon

Madrid, 28007, Spain

Location

Related Publications (1)

• 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.

  PMID: 35727196 DERIVED

MeSH Terms

Interventions

Hemiarthroplasty

Intervention Hierarchy (Ancestors)

Arthroplasty, Replacement; Arthroplasty; Orthopedic Procedures; Surgical Procedures, Operative; Plastic Surgery Procedures; Prosthesis Implantation

Results Point of Contact

• Title: Dr. Carlos Álvarez
• Organization: Hospital Gregorio Marañón

calvargon@gmail.com

0034915868000

Study Officials

• Carlos Alvarez, MD

  Hospital General Universitario Gregorio Marañon

  PRINCIPAL INVESTIGATOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Head of Department

Study Record Dates

• First Submitted: February 6, 2014
• First Posted: March 3, 2014
• Study Start: May 1, 2013
• Primary Completion: August 5, 2015
• Study Completion: August 6, 2016
• Last Updated: April 14, 2020
• Results First Posted: April 14, 2020

Record last verified: 2020-04

Locations

ES (1)