"Suture of the Tuberosities in Inverted Prostheses" Implanted for Acute Fractures of the Proximal Humerus?.

"It is Necessary to Suture the Tuberosities in Inverted Prostheses Implanted for Acute Fractures of the Proximal Humerus?. Prospective Randomized Study

Complex fractures of the proximal humerus in elderly patients constitute a growing problem. Osteoporosis linked to these fractures prevents osteosynthesis correctly, so that if the offset between the fragments is large, it is necessary to implant a prosthesis. Inverted prostheses, normally used for the treatment of osteoarthritis with absence of the rotator cuff, have become the treatment of choice in these fractures obtaining very favorable results. Traditionally, once the prosthesis is implanted, they are sutured the tuberosities with the rotator cuff tendons to the prosthesis. This gesture is supposed to will improve patient function. However, this prosthesis was originally designed for use in patients without a rotator cuff, so the need for this suture, which lengthens surgical time and requires an increase in the number of sutures, which can potentially increase the risk of infection. With the results of this study, it would be possible to reduce the surgical time, the number of inert materials implanted, and potentially the risk of infection.

Study Overview

• Status: Not yet recruiting
• Conditions: Proximal Humeral Fractures, Reverse Shoulder Prostheses, Tuberosities
• Intervention / Treatment: Procedure: tuberosity suture

Detailed Description

Complex fractures of the proximal humerus in elderly patients constitute a growing problem. Osteoporosis linked to these fractures prevents osteosynthesis correctly, so that if the offset between the fragments is large, it is necessary to implant a prosthesis. Inverted prostheses, normally used for the treatment of osteoarthritis with absence of the rotator cuff, have become the treatment of choice in these fractures obtaining very favorable results. Traditionally, once the prosthesis is implanted, they are sutured the tuberosities with the rotator cuff tendons to the prosthesis. This gesture is supposed to will improve patient function. However, this prosthesis was originally designed for use in patients without a rotator cuff, so the need for this suture, which lengthens surgical time and requires an increase in the number of sutures, which can potentially increase the risk of infection. With the results of this study, it would be possible to reduce the surgical time, the number of inert materials implanted, and potentially the risk of infection.

Primary objective:

To determine if there are differences in the perception of quality of life measured by through the Simple Shoulder Test scale, among the patients in whom sutured the tuberosities and patients who have had the tuberosities excised tuberosities.

Secondary objectives:

To determine if there are differences between the patients in whom suturing has been the tuberosities and patients who have had their tuberosities excised about:

• SPADI quality of life test.
• Constant functional test.
• number of prosthetic dislocations
• Percentage of scapular notch development measured according to the Sirveaux scale.
• Number of dislocations.
• number of infections.
• number of revision surgeries.

• Study Type: Interventional
• Enrollment (Anticipated): 90
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years to 85 years (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• patients > 65 yrs. and < 85 yrs.
• Acute fracture of the proximal humerus.
• implantation of inverted shoulder prosthesis.

Exclusion Criteria:

• acute fractures of more than 3 weeks of evolution
• Associated fractures.
• senile dementia and/or cognitive alterations that prevent compliance protocols

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
Experimental: Patients without tuberosity reconstruction; patients undergoing reverse shoulder arthroplasty because a proximal humeral fracture with suturing of the tuberosities	Procedure: tuberosity suture; to suture or not suture the tuberosities in reverse shoulder arthroplasty because of a proximal humeral fracture
Active Comparator: Patients with tuberosity reconstruction; patients undergoing reverse shoulder arthroplasty because a proximal humeral fracture without suturing of the tuberosities	Procedure: tuberosity suture; to suture or not suture the tuberosities in reverse shoulder arthroplasty because of a proximal humeral fracture

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Simple Shoulder Test	Primary objective: To determine if there are differences in the perception of quality of life measured by through the Simple Shoulder Test scale, among the patients in whom sutured the tuberosities and patients who have had the tuberosities excised tuberosities.	24 months

Collaborators and Investigators

• Sponsor: Hospital del Mar

Study record dates

Study Major Dates

• Study Start (Anticipated): September 1, 2022
• Primary Completion (Anticipated): September 1, 2023
• Study Completion (Anticipated): September 1, 2025

Study Registration Dates

• First Submitted: July 12, 2022
• First Submitted That Met QC Criteria: July 14, 2022
• First Posted (Actual): July 18, 2022

Study Record Updates

• Last Update Posted (Actual): July 18, 2022
• Last Update Submitted That Met QC Criteria: July 14, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Shoulder Injuries; Arm Injuries; Fractures, Bone; Humeral Fractures; Shoulder Fractures
• Other Study ID Numbers: 2022/10519

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

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