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

NCT ID: NCT05462691

Last Updated: 2022-07-18

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-09-01
• Study Completion Date: 2025-09-01

Brief Summary

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.

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.

Conditions

Proximal Humeral Fractures, Reverse Shoulder Prostheses, Tuberosities

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Patients without tuberosity reconstruction

patients undergoing reverse shoulder arthroplasty because a proximal humeral fracture with suturing of the tuberosities

Group Type: EXPERIMENTAL

tuberosity suture

Intervention Type: PROCEDURE

to suture or not suture the tuberosities in reverse shoulder arthroplasty because of a proximal humeral fracture

Patients with tuberosity reconstruction

patients undergoing reverse shoulder arthroplasty because a proximal humeral fracture without suturing of the tuberosities

Group Type: ACTIVE_COMPARATOR

tuberosity suture

Intervention Type: PROCEDURE

to suture or not suture the tuberosities in reverse shoulder arthroplasty because of a proximal humeral fracture

Interventions

tuberosity suture

to suture or not suture the tuberosities in reverse shoulder arthroplasty because of a proximal humeral fracture

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 65 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hospital del Mar

OTHER

Sponsor Role: lead

Responsible Party

Carlos Torrens

Clinical Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Carlos Torrens, MD

Role: CONTACT

CTorrens@psmar.cat

003493674100 ext. 4201

Other Identifiers

2022/10519

Identifier Type: -

Identifier Source: org_study_id