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Longterm Outcome of the Delta III Inverse Prosthesis

Primary Purpose

Rotator Cuff Tear Arthropathy

Status
Withdrawn
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Implantation of a Delta III Prosthesis
Sponsored by
Schulthess Klinik
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rotator Cuff Tear Arthropathy

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • implantation of a Delta III - prothesis
  • timeframe (Oct 1998 - Dec 2002)
  • delta-pectoral approach
  • written informed consent

Exclusion Criteria:

  • Implantation because of a revision
  • Complaints, which make it difficult to follow instructions or even prevent

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Delta III

    Arm Description

    Implantation of a Delta III Prosthesis

    Outcomes

    Primary Outcome Measures

    Constant Murley Score

    Secondary Outcome Measures

    cASES
    pASES
    SF-36
    DASH-Questionannaire
    SPADI
    x-ray (Sperling Classification)
    x-ray (Sirveaux Classification)
    Description of the glenoid
    Description of the situation: e.g. any dissociation of the gleonid any migration of the glenoid
    Description of the stem
    Description of the situation: e.g. - change of the position

    Full Information

    First Posted
    June 5, 2013
    Last Updated
    August 8, 2014
    Sponsor
    Schulthess Klinik
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01873651
    Brief Title
    Longterm Outcome of the Delta III Inverse Prosthesis
    Official Title
    The Reverse Delta III Total Shoulder Prosthesis - Longerm Results in 98 Patients
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2014
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    The study has been withdrawn due to too few patients
    Study Start Date
    October 2013 (undefined)
    Primary Completion Date
    December 2013 (Anticipated)
    Study Completion Date
    March 2014 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Schulthess Klinik

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The aim of the study is to describe the results after > 10 years due to a prosthesis implant.
    Detailed Description
    The aim of the study is to measure the gain of the benefit in function an painreduction which the patient yields with this type of prosthesis in a longterm (> 10 years )outcome. Additionally the long-term results will be compared with the mid-term results and the literature. Furthermore the complications since the mid-term measurement time point will be determined.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Rotator Cuff Tear Arthropathy

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Delta III
    Arm Type
    Experimental
    Arm Description
    Implantation of a Delta III Prosthesis
    Intervention Type
    Device
    Intervention Name(s)
    Implantation of a Delta III Prosthesis
    Intervention Description
    Implantation of a Delta III Prosthesis
    Primary Outcome Measure Information:
    Title
    Constant Murley Score
    Time Frame
    10 years
    Secondary Outcome Measure Information:
    Title
    cASES
    Time Frame
    10 years
    Title
    pASES
    Time Frame
    10 years
    Title
    SF-36
    Time Frame
    10 years
    Title
    DASH-Questionannaire
    Time Frame
    10 years
    Title
    SPADI
    Time Frame
    10 years
    Title
    x-ray (Sperling Classification)
    Time Frame
    10 years
    Title
    x-ray (Sirveaux Classification)
    Time Frame
    10 years
    Title
    Description of the glenoid
    Description
    Description of the situation: e.g. any dissociation of the gleonid any migration of the glenoid
    Time Frame
    10 years
    Title
    Description of the stem
    Description
    Description of the situation: e.g. - change of the position
    Time Frame
    10 years

    10. Eligibility

    Sex
    All
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: implantation of a Delta III - prothesis timeframe (Oct 1998 - Dec 2002) delta-pectoral approach written informed consent Exclusion Criteria: Implantation because of a revision Complaints, which make it difficult to follow instructions or even prevent
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Matthias Flury, Dr.
    Organizational Affiliation
    Schulthess Klinik, Upper Extremities Department
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    Longterm Outcome of the Delta III Inverse Prosthesis

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