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

NCT ID: NCT02075476

Last Updated: 2020-04-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-05-31
• Study Completion Date: 2016-08-06

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.

Conditions

A02.835.232.087.090.400.400

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Hemiarthroplasty Global Fx(DePuy)

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

Group Type: ACTIVE_COMPARATOR

Hemiarthroplasty

Intervention Type: PROCEDURE

reverse arthroplasty Delta Xtent(DePuy)

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

Group Type: EXPERIMENTAL

reverse arthroplasty

Intervention Type: PROCEDURE

Interventions

Hemiarthroplasty

Intervention Type: PROCEDURE

reverse arthroplasty

Intervention Type: PROCEDURE

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.

• Minimum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Carlos Alvarez

OTHER

Sponsor Role: lead

Responsible Party

Carlos Alvarez

Head of Department

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Carlos Alvarez, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital General Universitario Gregorio Marañon

Locations

Hospital General Universitario Gregorio Marañon

Madrid, , Spain

Countries

Spain

References

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.

Reference Type: DERIVED

PMID: 35727196 (View on PubMed)

Other Identifiers

FRALUX-34

Identifier Type: -

Identifier Source: org_study_id