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GSSNRSA: Glenosphere Size and Scapular Notch in RSA, Prospective Randomized Study

Sponsor
Hospital del Mar (Other)
Overall Status
Completed
CT.gov ID
NCT03730597
Collaborator
(none)
95
Enrollment
2
Arms
24.3
Actual Duration (Months)

Study Details

Study Description

Brief Summary

Scapular notch can be reduced by using bigger glenospheres but in some patients it cannot be implanted because of small size. If small size of glenosphere is used then scapular notch may increase. To improve that situation, eccentricity has been added to some glenospheres to increase glenoid overhanging. The objective is to assess if eccentricity can avoid scapular notch as effectively as bigger glenospheres.

Condition or Disease Intervention/Treatment Phase
  • Device: reverse shoulder arthroplasty
 N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
95 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
randomized studyrandomized study
Masking:
Single (Outcomes Assessor)
Masking Description:
blinded to purpose of study and to randomization
Primary Purpose:
Prevention
Official Title:
Influenze of Glenosphere Size in Scapular Notch Development. Randomized Study Comparing 42 to 38 ECC
Actual Study Start Date :
Sep 1, 2014
Actual Primary Completion Date :
Sep 9, 2016
Actual Study Completion Date :
Sep 9, 2016

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: glenosphere 42

patients receiving a reverse shoulder arthroplasty with a glenosphere sized 42. reverse shoulder prosthesis implantation X-Ray analysis to detect scapular notch

Device: reverse shoulder arthroplasty
prosthesis implantation
Other Names:
  • Delta X-tend

    		•
    Active Comparator: glenosphere 38 ECC

    patients receiving a reverse shoulder arthroplasty with a glenosphere sized 38 ECC reverse shoulder prosthesis implantation X-Ray analysis to detect scapular notch

    Device: reverse shoulder arthroplasty
    prosthesis implantation
    Other Names:
  • Delta X-tend

    		•

    Outcome Measures

    Primary Outcome Measures

    1. scapular notch development [two years]

      X-ray assessment of scapular notch development

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Patients undergoing reverse shoulder prosthesis because of rotator cuff disordes andacute fractures
    Exclusion Criteria:

    • patients with previous surgery

    • patients with deltoid deficiency

    • patients with acute infection

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Hospital del Mar

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Carlos Torrens, Head of Shoulder Unit, Hospital del Mar
    ClinicalTrials.gov Identifier:
    NCT03730597
    Other Study ID Numbers:
    • Torrens.00
    • CTorrens
    First Posted:
    Nov 5, 2018
    Last Update Posted:
    Mar 12, 2019
    Last Verified:
    Oct 1, 2018
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    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

    Study Results

    No Results Posted as of Mar 12, 2019