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An Exploratory Randomized Controlled Study of Arthroscopic Inlay Bristow Procedure for Recurrent Anterior Shoulder Dislocation

Primary Purpose

Shoulder Dislocation

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Inlay Bristow
Bristow
Sponsored by
Peking University Third Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Shoulder Dislocation focused on measuring bristow, shoulder dislocation

Eligibility Criteria

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

Inclusion Criteria:

  • Recurrent anterior shoulder instability based on medical history, physical examination, and radiological results.
  • A glenoid defect ≥10% but <25%
  • Participation in high-demand (collision and overhead) sports combined with the presence of a glenoid defect <25% of the glenoid or without defect
  • Failure after Bankart repair

Exclusion Criteria:

  • Multi-directional shoulder instability
  • Uncontrolled epilepsy
  • History of receiving Bristow-Latarjet procedure.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Inlay Bristow Group

    Onlay Bristow Group

    Arm Description

    Inlay Bristow procedure

    Onlay Bristow procedure

    Outcomes

    Primary Outcome Measures

    Bone union rate
    Bone healing was observed in 3D-CT. The bone healing rate was obtained by dividing the number of people who achieved bone healing by the total number of people
    Bone union rate
    Bone healing was observed in 3DCT. The bone healing rate was obtained by dividing the number of people who achieved bone healing by the total number of people
    ASES score
    The ASES score (Michener 2002) is a 10-item measure of shoulder pain and function. Pain is assessed on a 10-cm visual analog scale (VAS) and accounts for 50% of the total score. The remaining 50% of the score is determined by the responses to 10 4-point Likert-scale questions related to physical function.

    Secondary Outcome Measures

    dislocation rate
    The dislocation rate was obtained by dividing the number of people who dislocated postopratively by the total number of people
    VAS for pain score
    The visual analog scale (VAS) for pain score is the most commonly used to describe pain levels in patients, ranging from 0 to 10, with a higher score indicating more intense pain.
    Active shoulder ranges of motion
    internal rotation at the side, and external and internal rotation at 90° of abduction

    Full Information

    First Posted
    June 25, 2021
    Last Updated
    July 7, 2021
    Sponsor
    Peking University Third Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04949217
    Brief Title
    An Exploratory Randomized Controlled Study of Arthroscopic Inlay Bristow Procedure for Recurrent Anterior Shoulder Dislocation
    Official Title
    An Exploratory Randomized Controlled Study of Arthroscopic Inlay Bristow Procedure for Recurrent Anterior Shoulder Dislocation
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2021
    Overall Recruitment Status
    Completed
    Study Start Date
    January 17, 2017 (Actual)
    Primary Completion Date
    March 20, 2018 (Actual)
    Study Completion Date
    May 31, 2021 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Peking University Third Hospital

    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 evaluate the clinical and radiographic outcomes of arthroscopic inlay bristow procedure in treating recurrent anterior shoulder instability.
    Detailed Description
    Aim: To compare the clinical and radiographic outcomes following the arthroscopic Chinese Unique Inlay Bristow (Cuistow) procedure and the arthroscopic Bristow procedure. Background: The Cuistow procedure is a modified Bristow surgery in which a Mortise and Tenon structure was added to the contact surface between the coracoid tip and the glenoid. In previous retrospective study, patients received Cuistow procedure have satisfying clinical performance and excellent postoperative bone healing rate (96.1%). However, no prospective randomized controlled trial was performed. Methods: 70 patients with recurrent anterior shoulder instability were included and randomized to either an arthroscopic Cuistow procedure or arthroscopic Bristow procedure. Radiological evaluations with 3D CT scan were performed preoperatively, immediately after the operation, and postoperatively at three months and during the final follow-up (more than 2 years). Clinical assessment for a minimum of 24 months including the 10-point visual analog scale for pain and subjective instability, University of California at Los Angeles scoring system (UCLA score), American Shoulder and Elbow Surgeons score (ASES score), ROWE score, Subjective Shoulder Value (SSV) and active range of motion were completed by independent observers and analyzed.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Shoulder Dislocation
    Keywords
    bristow, shoulder dislocation

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    70 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Inlay Bristow Group
    Arm Type
    Experimental
    Arm Description
    Inlay Bristow procedure
    Arm Title
    Onlay Bristow Group
    Arm Type
    Active Comparator
    Arm Description
    Onlay Bristow procedure
    Intervention Type
    Procedure
    Intervention Name(s)
    Inlay Bristow
    Other Intervention Name(s)
    Cuistow
    Intervention Description
    A modified Bristow procedure
    Intervention Type
    Procedure
    Intervention Name(s)
    Bristow
    Intervention Description
    Traditional Bristow procedure
    Primary Outcome Measure Information:
    Title
    Bone union rate
    Description
    Bone healing was observed in 3D-CT. The bone healing rate was obtained by dividing the number of people who achieved bone healing by the total number of people
    Time Frame
    3-month postoperatily
    Title
    Bone union rate
    Description
    Bone healing was observed in 3DCT. The bone healing rate was obtained by dividing the number of people who achieved bone healing by the total number of people
    Time Frame
    2-year postoperatively
    Title
    ASES score
    Description
    The ASES score (Michener 2002) is a 10-item measure of shoulder pain and function. Pain is assessed on a 10-cm visual analog scale (VAS) and accounts for 50% of the total score. The remaining 50% of the score is determined by the responses to 10 4-point Likert-scale questions related to physical function.
    Time Frame
    2-year postoperatively
    Secondary Outcome Measure Information:
    Title
    dislocation rate
    Description
    The dislocation rate was obtained by dividing the number of people who dislocated postopratively by the total number of people
    Time Frame
    2-year postoperatively
    Title
    VAS for pain score
    Description
    The visual analog scale (VAS) for pain score is the most commonly used to describe pain levels in patients, ranging from 0 to 10, with a higher score indicating more intense pain.
    Time Frame
    2-year postoperatively
    Title
    Active shoulder ranges of motion
    Description
    internal rotation at the side, and external and internal rotation at 90° of abduction
    Time Frame
    2-year postoperatively

    10. Eligibility

    Sex
    All
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Recurrent anterior shoulder instability based on medical history, physical examination, and radiological results. A glenoid defect ≥10% but <25% Participation in high-demand (collision and overhead) sports combined with the presence of a glenoid defect <25% of the glenoid or without defect Failure after Bankart repair Exclusion Criteria: Multi-directional shoulder instability Uncontrolled epilepsy History of receiving Bristow-Latarjet procedure.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Guoqing Cui
    Organizational Affiliation
    Peking University Third Hospital
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    An Exploratory Randomized Controlled Study of Arthroscopic Inlay Bristow Procedure for Recurrent Anterior Shoulder Dislocation

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