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"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
Hospital del Mar
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Proximal Humeral Fractures, Reverse Shoulder Prostheses, Tuberosities

Eligibility Criteria

65 Years - 85 Years (Older Adult)All SexesDoes not accept healthy volunteers

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

    First Posted
    July 12, 2022
    Last Updated
    July 14, 2022
    Sponsor
    Hospital del Mar
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    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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