Reverse Or Nothing For Complex Proximal Humeral Fractures

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

81 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-09-30

Study Completion Date

2023-08-31

Brief Summary

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Reverse shoulder prosthesis has recently emerged as an acute treatment for complex proximal humeral fractures. Promising functional results have been reported in observational papers.

However, no clinical trials have yet been reported when comparing the conservative treatment to surgical treatment through the use of reverse shoulder arthroplasty.

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Detailed Description

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Introduction The proximal humeral fractures are frequent in the investigator's environment. Among them, about 20% are considered as complex features. Conservative treatment has traditionally offered an extensive range of results. The reverse shoulder prosthesis as a treatment for acute fractures of the proximal humeral in the elderly population has changed the therapeutic approach of this acute pathology. However, high-level evidence-based studies are still not available, when comparing the conservative treatment with the treatment with reverse shoulder prosthesis.

Objective To compare the functional results and complications of elderly patients presenting acute complex fractures of the proximal humerus through two types of treatments; conservative treatment and treatment with reverse shoulder prosthesis.

Methodology A prospective, multicentre and randomized study comparing conservative treatment with the surgical treatment at two years followup by the use of functional shoulder assessment (Constant scale), complications and re-interventions associated with each treatment. The quality of life will also be analyzed through the SF-36 health questionnaire

Expected results The null hypothesis of the work is based on the appearance of non-significant differences between the two groups of the study (conservative vs. surgical treatment), concerning functional status, complications, and re-interventions

Conditions

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Humeral Fractures

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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CONSERVATIVE TREATMENT

Conservative treatment is conceived to the use of sling for three weeks, followed by rehabilitation protocol

Group Type NO_INTERVENTION

No interventions assigned to this group

REVERSE ARTHROPLASTY TREATMENT

This group receives a surgical intervention by the use of reverse shoulder arthroplasty through deltopectoral approach and tuberosities reattachment.

It is followed by the same rehabilitation protocol than conservative treatment

Group Type EXPERIMENTAL

Reverse shoulder arthroplasty

Intervention Type DEVICE

The implantation of reverse shoulder prosthesis, and reattachment of greater and lesser tuberosities

Interventions

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Reverse shoulder arthroplasty

The implantation of reverse shoulder prosthesis, and reattachment of greater and lesser tuberosities

Intervention Type DEVICE

Other Intervention Names

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Shoulder prosthesis

Eligibility Criteria

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Inclusion Criteria

* Patients with mental conditions available for rehabilitation protocols
* Patients presenting a 3 or 4 part proximal humeral fracture

Exclusion Criteria

* Extremely displaced fractures with no bony contact or less than 1 cm.
* Cognitive impairment (Pfeiffer test \>3)
* Shoulder dislocations
* Unable to sign informed consent or unable to respond to questionnaires
* Trauma or previous surgery of the extremity
* Open or pathological fracture
* Vascular or neurological injury associated
* Unable to collaborate with rehabilitation
* Patients with serious comorbidities that discourage surgery

Minimum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No