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

Carlos Alvarez

Status: Completed

Conditions: A02.835.232.087.090.400.400

Treatments: Procedure: Hemiarthroplasty; Procedure: reverse arthroplasty

Study type: Interventional

Funder types: Other

Identifiers

NCT02075476

FRALUX-34

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 patients

Sex: All

Ages: 70+ years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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40 participants in 2 patient groups

Hemiarthroplasty Global Fx(DePuy)

Active Comparator group

Description:

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

Treatment:

Procedure: Hemiarthroplasty

reverse arthroplasty Delta Xtent(DePuy)

Experimental group

Description:

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

Treatment:

Procedure: reverse arthroplasty