Reverse Or Nothing For Complex Proximal Humeral Fractures

Consorci Sanitari de l'Anoia

Status: Completed

Conditions: Humeral Fractures

Treatments: Device: Reverse shoulder arthroplasty

Study type: Interventional

Funder types: Other

Identifiers

NCT03610113

AC12-045

Details and patient eligibility

About

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.

Full description

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

Enrollment: 81 patients

Sex: All

Ages: 70+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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81 participants in 2 patient groups

CONSERVATIVE TREATMENT

No Intervention group

Description:

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

REVERSE ARTHROPLASTY TREATMENT

Experimental group

Description:

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

Treatment:

Device: Reverse shoulder arthroplasty