NCT03610113

Reverse Or Nothing For Complex Proximal Humeral Fractures

Reverse Shoulder Arthroplasty Versus Conservative Treatment For Complex Proximal Fractures in Elderly Patients

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 81 (actual)
• Sponsor: Consorci Sanitari de l'Anoia · Academic / Other
• Sex: All
• Age: 70 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed 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

Conditions

• Humeral Fractures

Interventions

Type	Name	Description
DEVICE	Reverse shoulder arthroplasty	The implantation of reverse shoulder prosthesis, and reattachment of greater and lesser tuberosities

Timeline

• Start date: 2016-09-01
• Primary completion: 2023-08-01
• Completion: 2023-08-01
• First posted: 2018-08-01
• Last updated: 2023-08-29

Locations

1 site across 1 country: Spain