"Suture of the Tuberosities in Inverted Prostheses" Implanted for Acute Fractures of the Proximal Humerus?.
Primary Purpose
Proximal Humeral Fractures, Reverse Shoulder Prostheses, Tuberosities
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
tuberosity suture
Sponsored by
About this trial
This is an interventional treatment trial for Proximal Humeral Fractures, Reverse Shoulder Prostheses, Tuberosities
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Patients without tuberosity reconstruction
Patients with tuberosity reconstruction
Arm Description
patients undergoing reverse shoulder arthroplasty because a proximal humeral fracture with suturing of the tuberosities
patients undergoing reverse shoulder arthroplasty because a proximal humeral fracture without suturing of the tuberosities
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05462691
Brief Title
"Suture of the Tuberosities in Inverted Prostheses" Implanted for Acute Fractures of the Proximal Humerus?.
Official Title
"It is Necessary to Suture the Tuberosities in Inverted Prostheses Implanted for Acute Fractures of the Proximal Humerus?. Prospective Randomized Study
Study Type
Interventional
2. Study Status
Record Verification Date
July 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
September 1, 2022 (Anticipated)
Primary Completion Date
September 1, 2023 (Anticipated)
Study Completion Date
September 1, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hospital del Mar
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Proximal Humeral Fractures, Reverse Shoulder Prostheses, Tuberosities
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
prospective randomized trial
Masking
ParticipantOutcomes Assessor
Masking Description
patients will be blinded to the assignment group. outcomes assessors will be blinded to the assignment group
Allocation
Randomized
Enrollment
90 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Patients without tuberosity reconstruction
Arm Type
Experimental
Arm Description
patients undergoing reverse shoulder arthroplasty because a proximal humeral fracture with suturing of the tuberosities
Arm Title
Patients with tuberosity reconstruction
Arm Type
Active Comparator
Arm Description
patients undergoing reverse shoulder arthroplasty because a proximal humeral fracture without suturing of the tuberosities
Intervention Type
Procedure
Intervention Name(s)
tuberosity suture
Intervention Description
to suture or not suture the tuberosities in reverse shoulder arthroplasty because of a proximal humeral fracture
Primary Outcome Measure Information:
Title
Simple Shoulder Test
Description
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.
Time Frame
24 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
65 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Carlos Torrens, MD
Phone
003493674100
Ext
4201
Email
CTorrens@psmar.cat
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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"Suture of the Tuberosities in Inverted Prostheses" Implanted for Acute Fractures of the Proximal Humerus?.
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