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Influenze of Approach in Reversed Shoulder Prosthesis

Primary Purpose

Outcomes Assessments, Patients, Rotator Cuff Arthropathy

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Reverse Shoulder Arthroplasty
Sponsored by
Hospital del Mar
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Outcomes Assessments, Patients focused on measuring reverse shoulder arthroplasty, scapular notch, deltopectoral, anterosuperior approach

Eligibility Criteria

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

Inclusion Criteria:

  • Patients with secondary osteoarthritis of the shoulder who are candidates for an inverted prosthesis
  • Acute fractures <2 weeks of evolution in patients candidates for inverted prostheses
  • No previous surgeries of the affected shoulder
  • Acceptance by the patient to participate in the study

Exclusion Criteria:

  • Fractures> 2 weeks of evolution
  • Previous surgeries on the affected shoulder
  • Not signing the informed consent
  • Cognitive impairment
  • Institutionalization of the patient

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Other

    Other

    Arm Label

    deltopectoral

    antero-superior

    Arm Description

    deltopectoral surgical approach

    antero-superior approach

    Outcomes

    Primary Outcome Measures

    positioning of the metaglene of the reverse shoulder prostheses
    to determine the metaglene postioning in both surgical approaches by measuring the distance between the inferior part of the metaglene and the glenoid inferior rim. The measurement will be done in an AP X-ray view of the shoulder and with the help of the measure tool in the PACS system of viewing.

    Secondary Outcome Measures

    scapular notch
    determine scapular notch development in both approaches as determined with the aid of an AP X-ray view of the shoulder and thus classifying the scapular notch development according to Sirveaux et al. classification system.
    functional outcome
    determine the functional outcome as measured with the Constant Score at 2-years follow-up

    Full Information

    First Posted
    May 20, 2020
    Last Updated
    March 25, 2021
    Sponsor
    Hospital del Mar
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04405947
    Brief Title
    Influenze of Approach in Reversed Shoulder Prosthesis
    Official Title
    Randomized Prospective Study Comparing Reversed Shoulder Prosthesis Through the Superior Anterior Approach and the Deltopectoral Approach
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2021
    Overall Recruitment Status
    Completed
    Study Start Date
    January 13, 2016 (Actual)
    Primary Completion Date
    January 18, 2018 (Actual)
    Study Completion Date
    October 29, 2020 (Actual)

    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
    Yes

    5. Study Description

    Brief Summary
    To determine the differences in the placement of the glenoid implant of the inverted prostheses when they are implanted using a superior approach and using an anterior approach.
    Detailed Description
    Inverted prostheses have proven to be effective in the treatment of all those pathologies that involve a deterioration of the rotator cuff (secondary arthropathy, acute fractures, sequelae of fractures, tumor surgery and revision surgery). Despite this, numerous complications have been described after the use of inverted prostheses, such as glenoid erosion, infections, dislocation, or aseptic loosening. The most frequent complication related to the use of inverted prostheses is glenoid erosion that can occur in up to 96% of cases. This complication appears early in the evolution, usually before 2 years after surgery. Its clinical significance is not yet clear, but it seems that it may be a cause of long-term prosthetic loosening. To avoid the development of glenoid erosion, the best option is to place the glenoid component low, so that if the glenoid component is flush with the lower margin of the glena, the chances of developing glenoid erosion are significantly reduced. Two types of approaches have been used to implant these prostheses, the deltopectoral and the superior anterior approach. Each of them has its advantages and disadvantages, so that deltopectoral seems to improve surgical exposure and therefore favors the best placement of the glenoid component, but sacrifices the subscapularis tendon, increasing the risk of dislocation of the components. On the contrary, the superior anterior approach respects the subscapularis tendon, reducing the risk of dislocation of the components but gives worse surgical exposure.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Outcomes Assessments, Patients, Rotator Cuff Arthropathy
    Keywords
    reverse shoulder arthroplasty, scapular notch, deltopectoral, anterosuperior approach

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    prospective randomized study
    Masking
    Outcomes Assessor
    Masking Description
    given the fact that the different approaches come with different scars, just the outcomes assessor can be blinded
    Allocation
    Randomized
    Enrollment
    100 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    deltopectoral
    Arm Type
    Other
    Arm Description
    deltopectoral surgical approach
    Arm Title
    antero-superior
    Arm Type
    Other
    Arm Description
    antero-superior approach
    Intervention Type
    Procedure
    Intervention Name(s)
    Reverse Shoulder Arthroplasty
    Intervention Description
    implantation of a reversed shoulder prostheses through two different surgical approaches
    Primary Outcome Measure Information:
    Title
    positioning of the metaglene of the reverse shoulder prostheses
    Description
    to determine the metaglene postioning in both surgical approaches by measuring the distance between the inferior part of the metaglene and the glenoid inferior rim. The measurement will be done in an AP X-ray view of the shoulder and with the help of the measure tool in the PACS system of viewing.
    Time Frame
    2 years
    Secondary Outcome Measure Information:
    Title
    scapular notch
    Description
    determine scapular notch development in both approaches as determined with the aid of an AP X-ray view of the shoulder and thus classifying the scapular notch development according to Sirveaux et al. classification system.
    Time Frame
    2 years
    Title
    functional outcome
    Description
    determine the functional outcome as measured with the Constant Score at 2-years follow-up
    Time Frame
    2 years. The minimum value of the Constant Score is 0 and the maximum is 100. The higher scores mean a better outcome.

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    85 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Patients with secondary osteoarthritis of the shoulder who are candidates for an inverted prosthesis Acute fractures <2 weeks of evolution in patients candidates for inverted prostheses No previous surgeries of the affected shoulder Acceptance by the patient to participate in the study Exclusion Criteria: Fractures> 2 weeks of evolution Previous surgeries on the affected shoulder Not signing the informed consent Cognitive impairment Institutionalization of the patient

    12. IPD Sharing Statement

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