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A 2-Year Prospective Follow-up Study of the Global Unite Reverse Fracture Shoulder System for Proximal Humerus Fractures

Primary Purpose

Shoulder Fractures

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Reverse Total Shoulder Arthroplasty
Hemiarthroplasty
Sponsored by
Signe Rosner Rasmussen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Shoulder Fractures focused on measuring Humeral Fractures, Proximal

Eligibility Criteria

65 Years - 120 Years (Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Fracture or fracture dislocation not suitable for non-operative treatment or for osteosynthesis due to displacement and comminution
  • Patients older than 65-years of age, or younger than 65-year of age if the surgeon assesses the physiological age as older.
  • All patients, regardless of age, with an insufficient or irreparable rotator cuff

Exclusion Criteria:

  • Brachial plexus palsy
  • Previous ipsilateral fracture of clavicula, scapula, or proximal humerus
  • Cognitive disabilities or substance abuse enabling rehabilitation and follow-up
  • Patients without a Danish civil registration number

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    RTSA group

    Hemiarthroplasty group

    Arm Description

    Participants with a complex proximal humerus fracture given a RTSA

    Historical cohort of participants, operated with a hemiarthroplasty of the shoulder

    Outcomes

    Primary Outcome Measures

    Change in Constant score (CS)
    The CS consists of four parameters (pain, mobility, ADL, strength) assessing shoulder function after the treatment of shoulder injury, both subjectively and objectively. The scale rates from worst (0) to best (100) quality of shoulder function.

    Secondary Outcome Measures

    Change in Oxford Shoulder Score (OSS)
    The OSS is a patient related outcome-measure (PROM) validated for evaluating self-assessed functionality after shoulder surgery. The 12 questions, with five response options, gives a total score ranging from 12 points (no pain or functional impairment) to 60 points (worst).
    Change in Western Ontario Osteoarthritis of the Shoulder Index (WOOS)
    The WOOS is a patient-related outcome measurement, initially validated for patients with osteoarthritis of the shoulder. On four domains (physical symptoms, recreation/work, lifestyle, emotions) the visual analog scale measures shoulder-related quality-of-life with a maximum of 1900 points, which signifies highest quality of function.
    Change in EQ5D questionnaire
    The EQ-5D (EuroQuol 5 Dimension scale) questionnaire is a widely used patient-related outcome measurement for quality of life assessment in general, consisting of 25 dichotomous questions from five parameters and a visual analog scale to plot perceived health. A persons selfperceived health status is then evaluated as a 5-digit number, ranging from 11111 (having no problems) to 33333 (having problems in all 5 aspects), and as a number from 0 (worst imaginable health) to 100 (best imaginable health).
    Change in Numeric Ranking Scale
    Pain measured after surgery according to the Numeric Ranking Scale (NRS), where 0 is no pain and 10 is worst imaginable pain.
    Complications
    Postoperative complications or reoperation due to infection, nerve damage, vascular damage, iatrogenic perioperative fracture, or loosening of the implant.
    Change in humeral tuberosities
    Migration or resorption of the humeral tuberosities accessed qualitatively from the xrays.

    Full Information

    First Posted
    July 31, 2020
    Last Updated
    August 8, 2020
    Sponsor
    Signe Rosner Rasmussen
    Collaborators
    Herlev and Gentofte Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04507880
    Brief Title
    A 2-Year Prospective Follow-up Study of the Global Unite Reverse Fracture Shoulder System for Proximal Humerus Fractures
    Official Title
    A 2-Year Prospective Follow-up Study of the Global Unite Reverse Fracture Shoulder System for Proximal Humerus Fractures
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2020
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    August 1, 2020 (Anticipated)
    Primary Completion Date
    August 1, 2024 (Anticipated)
    Study Completion Date
    August 1, 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor-Investigator
    Name of the Sponsor
    Signe Rosner Rasmussen
    Collaborators
    Herlev and Gentofte Hospital

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    Yes
    Product Manufactured in and Exported from the U.S.
    Yes
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    The objective of this study is to evaluated the efficacy and safety of the reverse total shoulder prosthesis (RTSA) for complex proximal humerus fractures. The clinical results of RTSA will be compared to clinical results from a historical cohort, that received a hemiarthroplasty of the shoulder.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Shoulder Fractures
    Keywords
    Humeral Fractures, Proximal

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Crossover Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    42 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    RTSA group
    Arm Type
    Experimental
    Arm Description
    Participants with a complex proximal humerus fracture given a RTSA
    Arm Title
    Hemiarthroplasty group
    Arm Type
    Active Comparator
    Arm Description
    Historical cohort of participants, operated with a hemiarthroplasty of the shoulder
    Intervention Type
    Device
    Intervention Name(s)
    Reverse Total Shoulder Arthroplasty
    Intervention Description
    The RTSA (GLOBAL UNITE Reverse Fracture System) from DePuy Synthes.
    Intervention Type
    Device
    Intervention Name(s)
    Hemiarthroplasty
    Intervention Description
    The shoulder hemiarthroplasty
    Primary Outcome Measure Information:
    Title
    Change in Constant score (CS)
    Description
    The CS consists of four parameters (pain, mobility, ADL, strength) assessing shoulder function after the treatment of shoulder injury, both subjectively and objectively. The scale rates from worst (0) to best (100) quality of shoulder function.
    Time Frame
    The outcome is measured 3 months, 6 months, 1 year and 2 years after surgery
    Secondary Outcome Measure Information:
    Title
    Change in Oxford Shoulder Score (OSS)
    Description
    The OSS is a patient related outcome-measure (PROM) validated for evaluating self-assessed functionality after shoulder surgery. The 12 questions, with five response options, gives a total score ranging from 12 points (no pain or functional impairment) to 60 points (worst).
    Time Frame
    The outcome is measured 3 months, 6 months, 1 year and 2 years after surgery
    Title
    Change in Western Ontario Osteoarthritis of the Shoulder Index (WOOS)
    Description
    The WOOS is a patient-related outcome measurement, initially validated for patients with osteoarthritis of the shoulder. On four domains (physical symptoms, recreation/work, lifestyle, emotions) the visual analog scale measures shoulder-related quality-of-life with a maximum of 1900 points, which signifies highest quality of function.
    Time Frame
    The outcome is measured 3 months, 6 months, 1 year and 2 years after surgery
    Title
    Change in EQ5D questionnaire
    Description
    The EQ-5D (EuroQuol 5 Dimension scale) questionnaire is a widely used patient-related outcome measurement for quality of life assessment in general, consisting of 25 dichotomous questions from five parameters and a visual analog scale to plot perceived health. A persons selfperceived health status is then evaluated as a 5-digit number, ranging from 11111 (having no problems) to 33333 (having problems in all 5 aspects), and as a number from 0 (worst imaginable health) to 100 (best imaginable health).
    Time Frame
    The outcome is measured 3 months, 6 months, 1 year and 2 years after surgery
    Title
    Change in Numeric Ranking Scale
    Description
    Pain measured after surgery according to the Numeric Ranking Scale (NRS), where 0 is no pain and 10 is worst imaginable pain.
    Time Frame
    The outcome is measured 3 months, 6 months, 1 year and 2 years after surgery
    Title
    Complications
    Description
    Postoperative complications or reoperation due to infection, nerve damage, vascular damage, iatrogenic perioperative fracture, or loosening of the implant.
    Time Frame
    The outcome is registered 2 years after surgery
    Title
    Change in humeral tuberosities
    Description
    Migration or resorption of the humeral tuberosities accessed qualitatively from the xrays.
    Time Frame
    The outcome is measured 3 months, 6 months, 1 year and 2 years after surgery

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    65 Years
    Maximum Age & Unit of Time
    120 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Fracture or fracture dislocation not suitable for non-operative treatment or for osteosynthesis due to displacement and comminution Patients older than 65-years of age, or younger than 65-year of age if the surgeon assesses the physiological age as older. All patients, regardless of age, with an insufficient or irreparable rotator cuff Exclusion Criteria: Brachial plexus palsy Previous ipsilateral fracture of clavicula, scapula, or proximal humerus Cognitive disabilities or substance abuse enabling rehabilitation and follow-up Patients without a Danish civil registration number
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Signe R Rasmussen, MD
    Phone
    +4526623427
    Email
    signe.nanna.rosner.rasmussen.01@regionh.dk
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Bo S Olsen, Professor
    Organizational Affiliation
    Herlev and Gentofte Hospital
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    A 2-Year Prospective Follow-up Study of the Global Unite Reverse Fracture Shoulder System for Proximal Humerus Fractures

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