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Sling vs No Sling After Reverse Total Shoulder Arthroplasty: A Randomized Control Trial

Primary Purpose

Shoulder Disease, Rotator Cuff Tear Arthropathy, Shoulder Osteoarthritis

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Time of Sling Use
Sponsored by
Duke University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Shoulder Disease

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Patient is scheduled to undergo a primary reverse shoulder arthroplasty procedure Patient voluntarily consents to participate in the study and has the mental and physical ability to participate in the study, fill out subjective questionnaires, return for follow-up visits, and comply with prescribed post-operative physical therapy at Duke. Patient meets indications for primary reverse shoulder arthroplasty for the following diagnosis Rotator cuff arthropathy Glenohumeral arthritis Patient is between 18-100 years old Patient is English speaking Patient lives in or within 20 miles of RTP Patient willing to do PT at a Duke facility Exclusion Criteria: A history of ipsilateral shoulder arthroplasty A history of shoulder septic arthritis A history of a proximal humeral fracture Chronic locked dislocation Rheumatoid arthritis Tumors Axillary nerve damage Non-functioning deltoid muscle Glenoid vault deficiency precluding baseplate fixation Infection and neuropathic joints Known or suspected non-compliance, drug or alcohol abuse Patients incapable of judgement or under tutelage Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, contraindication for imaging etc. The subject is related to investigator as family members, employees, or other dependent persons

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    No Intervention

    Experimental

    Arm Label

    Sling

    No Sling

    Arm Description

    Participants in the sling group will wear a sling according to current standard of care: 4 weeks postoperatively

    Participants in the no sling group will only wear a sling for three days postoperatively or until their nerve block wears off, whichever comes first

    Outcomes

    Primary Outcome Measures

    Number of participants who develop any kind of postoperative complication
    Incidence of postoperative complications

    Secondary Outcome Measures

    American Shoulder and Elbow Surgeons Standardized Shoulder Assessment Form (ASES) score
    The ASES is a 100-point scale that consists of two dimensions: pain and activities of daily living. There is one pain scale worth 50 points and ten activities of daily living worth 50 points. Total score ranges from 0 to 100 with a score of 0 indicating a worse shoulder condition and 100 indicating a better shoulder condition.
    Single Assessment Numeric Evaluation (SANE) score
    The SANE is a single-question outcome measure that asks patients to rate their function (as it pertains to the area being treated) on a scale of 0 to 100, where a higher score indicates greater function.
    Subjective Shoulder Value (SSV)
    The SSV score is defined as the subjective evaluation by the patient of shoulder function, expressed as a percentage of a normal shoulder. This score ranges from 0 to 100%.

    Full Information

    First Posted
    October 16, 2023
    Last Updated
    October 16, 2023
    Sponsor
    Duke University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT06092996
    Brief Title
    Sling vs No Sling After Reverse Total Shoulder Arthroplasty: A Randomized Control Trial
    Official Title
    Sling vs No Sling After Reverse Total Shoulder Arthroplasty: A Randomized Control Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    November 2023 (Anticipated)
    Primary Completion Date
    September 2025 (Anticipated)
    Study Completion Date
    September 2026 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Duke University

    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
    This study involves patients who will be undergoing a reverse total shoulder replacement at Duke University. 100 eligible will be randomly assigned into one of two groups, a sling or no sling group. Patients in the sling group will wear a sling for four weeks after their surgery while the no sling group will only wear a sling three days after their surgery or until their nerve block wears off, whichever comes first. Patients will follow their doctors normal follow up visit schedule after surgery, with visits at 2 weeks, 6 weeks, 3 months, 6 months, 1 year, and 2 years.
    Detailed Description
    The purpose of this study is to determine whether or not a sling is necessary after the nerve block has worn off postoperatively for patients undergoing reverse total shoulder arthroplasty. Patients who are scheduled for a reverse total shoulder with the participating investigators will be approached for potential participation in the study. Before the surgery, subjects will be randomly assigned to either the Sling (control) group or the No-Sling (investigational) group. The Sling, or control, group will wear a sling through 4 weeks postoperatively. The No Sling (investigational) group, will wear a sling either through 3 days postoperatively or until your nerve block wears off, whichever comes first. Following surgery, patients will be followed at their standard of care visits at 2 weeks, 6 weeks, 3 months, 6 months, 1 year, and 2 years after their surgical date. The investigators will collect data from these standard of care visits including PROs (including but not limited to ASES, SANE, and SSV), Adverse events data, and physical exam data including range of motion. Patients will be followed through their two-year visit and then taken off study.

    6. Conditions and Keywords

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

    7. Study Design

    Primary Purpose
    Other
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    100 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Sling
    Arm Type
    No Intervention
    Arm Description
    Participants in the sling group will wear a sling according to current standard of care: 4 weeks postoperatively
    Arm Title
    No Sling
    Arm Type
    Experimental
    Arm Description
    Participants in the no sling group will only wear a sling for three days postoperatively or until their nerve block wears off, whichever comes first
    Intervention Type
    Other
    Intervention Name(s)
    Time of Sling Use
    Intervention Description
    Standard sling worn for only three days (or until the nerve block wears off) post operatively
    Primary Outcome Measure Information:
    Title
    Number of participants who develop any kind of postoperative complication
    Description
    Incidence of postoperative complications
    Time Frame
    Up to the first 2 years following surgery
    Secondary Outcome Measure Information:
    Title
    American Shoulder and Elbow Surgeons Standardized Shoulder Assessment Form (ASES) score
    Description
    The ASES is a 100-point scale that consists of two dimensions: pain and activities of daily living. There is one pain scale worth 50 points and ten activities of daily living worth 50 points. Total score ranges from 0 to 100 with a score of 0 indicating a worse shoulder condition and 100 indicating a better shoulder condition.
    Time Frame
    Up to the first 2 years following surgery
    Title
    Single Assessment Numeric Evaluation (SANE) score
    Description
    The SANE is a single-question outcome measure that asks patients to rate their function (as it pertains to the area being treated) on a scale of 0 to 100, where a higher score indicates greater function.
    Time Frame
    Up to the first 2 years following surgery
    Title
    Subjective Shoulder Value (SSV)
    Description
    The SSV score is defined as the subjective evaluation by the patient of shoulder function, expressed as a percentage of a normal shoulder. This score ranges from 0 to 100%.
    Time Frame
    Up to the first 2 years following surgery

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    100 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Patient is scheduled to undergo a primary reverse shoulder arthroplasty procedure Patient voluntarily consents to participate in the study and has the mental and physical ability to participate in the study, fill out subjective questionnaires, return for follow-up visits, and comply with prescribed post-operative physical therapy at Duke. Patient meets indications for primary reverse shoulder arthroplasty for the following diagnosis Rotator cuff arthropathy Glenohumeral arthritis Patient is between 18-100 years old Patient is English speaking Patient lives in or within 20 miles of RTP Patient willing to do PT at a Duke facility Exclusion Criteria: A history of ipsilateral shoulder arthroplasty A history of shoulder septic arthritis A history of a proximal humeral fracture Chronic locked dislocation Rheumatoid arthritis Tumors Axillary nerve damage Non-functioning deltoid muscle Glenoid vault deficiency precluding baseplate fixation Infection and neuropathic joints Known or suspected non-compliance, drug or alcohol abuse Patients incapable of judgement or under tutelage Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, contraindication for imaging etc. The subject is related to investigator as family members, employees, or other dependent persons
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Caroline Questell, BSN
    Phone
    919-613-3670
    Email
    caroline.darragh@duke.edu
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Oke A Anakwenze, MD, MBA
    Organizational Affiliation
    Duke University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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    Sling vs No Sling After Reverse Total Shoulder Arthroplasty: A Randomized Control Trial

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