Reverse Or Nothing For Complex Proximal Humeral Fractures

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

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.

Study Overview

• Status: Completed
• Conditions: Humeral Fractures
• Intervention / Treatment: Device: 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

• Study Type: Interventional
• Enrollment (Actual): 81
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Barcelona
    • Collbató, Barcelona, Spain, 08293
      • Joan Miquel Noguera

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 70 years and older (Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: CONSERVATIVE TREATMENT; Conservative treatment is conceived to the use of sling for three weeks, followed by rehabilitation protocol
Experimental: 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	Device: Reverse shoulder arthroplasty; The implantation of reverse shoulder prosthesis, and reattachment of greater and lesser tuberosities; Other Names: Shoulder prosthesis

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain, Mobility, Strenght and Daily Life Activities. (Functional Outcome)	Constant-Murley Score. The Constant-Murley score (CMS) is a 100-points scale composed of a number of individual parameters. These parameters define the level of pain and the ability to carry out the normal daily activities of the patient.The Constant-Murley score was introduced to determine the functionality after the treatment of a shoulder injury and it ranges from 0 to 100 points. The test is divided into four subscales: pain (0 to 15 points), activities of daily living (0 to 20 points), strength (0 to 25 points) and range of motion: forward elevation (0 to 10 points), external rotation (o to 10 points), abduction (0 to 10 points) and internal rotation of the shoulder (0 to 10 points). Then, those range of motion items allocate from 0 to 40 points to the global score. The higher the score, the higher the quality of the function.	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participants with treatment-related surgical reinterventions	Number of participants with treatment-related adverse events that require an additional surgical treatment after the randomization; such as debridement, implant replacement In the control group; reinterventions will be measured by the necessity to receive a treatment for fracture sequelae such as an implantation of a shoulder prosthesis or any other surgical intervention	1 year
Number of participants with treatment-related shoulder joint infection	Acute infection will be defined as swelling, erythema, fever, purulent discharge or increasing level of biological parameters such as C-reactive protein (CRP), white blood cell count (WBC). Only expected in experimental/intervention group	1 year
Number of participants with treatment-related Implant dislocation	It is defined as the number of patients in experimental arm presenting a radiological disalignement between the humeral component (stem) and the glenoid component (glenosphere). Only expected in experimental/intervention group	1 year

Collaborators and Investigators

• Sponsor: Consorci Sanitari de l'Anoia
• Collaborators: Parc de Salut Mar; Germans Trias i Pujol Hospital
• Investigators: Study Director: Carlos Torrens, PhD, Parc de Salut Mar

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2016
• Primary Completion (Actual): August 1, 2023
• Study Completion (Actual): August 1, 2023

Study Registration Dates

• First Submitted: July 16, 2018
• First Submitted That Met QC Criteria: July 25, 2018
• First Posted (Actual): August 1, 2018

Study Record Updates

• Last Update Posted (Actual): August 29, 2023
• Last Update Submitted That Met QC Criteria: August 28, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Keywords: Conservative treatment; Reverse shoulder arthroplasty; Proximal humeral fractures
• Additional Relevant MeSH Terms: Wounds and Injuries; Arm Injuries; Fractures, Bone; Humeral Fractures
• Other Study ID Numbers: AC12-045

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No