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Coracoid Tunnel Widening After ACJ Tight Rope Fixation

Primary Purpose

Orthopedic Disorder, Orthopedic Devices Associated With Misadventures

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
arthroscopic fixation of Acute acromioclavicular joint injury using tight rope
Tight rope
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Orthopedic Disorder focused on measuring Acute acromioclavicular joint injury ., TightRope ., Coracoid tunnel dilatation., Loss of reduction.

Eligibility Criteria

15 Years - 60 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • patients with acute (≤ 3 weeks after injury) Rockwood grade III-V ACJ dislocation

Exclusion Criteria:

  • Patients with associated coracoid fracture, associated rotator cuff tears or glenohumeral arthritis

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    patient with Acute acromioclavicular joint injury

    Arm Description

    patient with Acute acromioclavicular joint injury

    Outcomes

    Primary Outcome Measures

    Coracoid tunnel diameter difference between immediate postoperative and final follow up
    Radiological outcome using CT scans
    Coraco-clavicular distance immediate postoperative and at final follow up
    Radiological outcome using X-rays

    Secondary Outcome Measures

    Constant-Murley shoulder score. Ranges from 0 representing worst outcome to 100 representing best outcome
    Clinical score using a questionnaire
    Disability of arm shoulder and Hand score ( DASH score) highest is 100 which represents worst outcome while lowest is 0 representing best possible outcome
    Clinical score using a questionnaire
    Oxford Shoulder score, a questionnaire of 12 questions each scores from 1 to 5. 1 being the fewest symptoms, 5 being the worst. The total score is 60 marks, the higher the score the worse the outcomes
    Clinical score using a questionnaire

    Full Information

    First Posted
    August 2, 2022
    Last Updated
    August 17, 2022
    Sponsor
    Cairo University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05504538
    Brief Title
    Coracoid Tunnel Widening After ACJ Tight Rope Fixation
    Official Title
    The Correlation Between Coracoid Tunnel Dilatation and Loss of Reduction After Arthroscopic Acromioclavicular Fixation Using Tightrope System, A CT Based Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2022
    Overall Recruitment Status
    Completed
    Study Start Date
    July 2016 (Actual)
    Primary Completion Date
    July 15, 2018 (Actual)
    Study Completion Date
    July 15, 2018 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Cairo University

    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

    5. Study Description

    Brief Summary
    studying coracoid tunnel widening after arthroscopic fixation of acute acromioclavicular joint (ACJ) dislocation using TightRope system and its correlation with loss of reduction and the functional scores.
    Detailed Description
    Abstract Purpose: To detect coracoid tunnel widening after arthroscopic fixation of acute acromioclavicular joint (ACJ) dislocation using TightRope system and its correlation with loss of reduction and the functional scores. Methods: From July 2016 to Dec 2018, a prospective study was performed at our hospital. Twenty-three patients with acute grade III-V ACJ dislocation were included in the study. Arthroscopic double tight-rope repair of the ACJ was performed. Coracoid tunnel widening was measured by computed tomography (CT) and coraco-clavicular distance was measured on the x-ray immediately post-operative and at 12 months. Constant Shoulder Score, Oxford Shoulder Score, Nottingham Clavicle Score and Visual analogue scale were used as outcome measures at 12 months. Level of evidence IV Keywords Acute acromioclavicular joint injury . TightRope . Coracoid tunnel dilatation. Loss of reduction.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Orthopedic Disorder, Orthopedic Devices Associated With Misadventures
    Keywords
    Acute acromioclavicular joint injury ., TightRope ., Coracoid tunnel dilatation., Loss of reduction.

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    23 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    patient with Acute acromioclavicular joint injury
    Arm Type
    Experimental
    Arm Description
    patient with Acute acromioclavicular joint injury
    Intervention Type
    Procedure
    Intervention Name(s)
    arthroscopic fixation of Acute acromioclavicular joint injury using tight rope
    Intervention Description
    arthroscopic fixation of Acute acromioclavicular joint injury using tight rope
    Intervention Type
    Device
    Intervention Name(s)
    Tight rope
    Intervention Description
    Adjustable button device from Arthrex Naples USA
    Primary Outcome Measure Information:
    Title
    Coracoid tunnel diameter difference between immediate postoperative and final follow up
    Description
    Radiological outcome using CT scans
    Time Frame
    1 year
    Title
    Coraco-clavicular distance immediate postoperative and at final follow up
    Description
    Radiological outcome using X-rays
    Time Frame
    1 year
    Secondary Outcome Measure Information:
    Title
    Constant-Murley shoulder score. Ranges from 0 representing worst outcome to 100 representing best outcome
    Description
    Clinical score using a questionnaire
    Time Frame
    1 year
    Title
    Disability of arm shoulder and Hand score ( DASH score) highest is 100 which represents worst outcome while lowest is 0 representing best possible outcome
    Description
    Clinical score using a questionnaire
    Time Frame
    1 year
    Title
    Oxford Shoulder score, a questionnaire of 12 questions each scores from 1 to 5. 1 being the fewest symptoms, 5 being the worst. The total score is 60 marks, the higher the score the worse the outcomes
    Description
    Clinical score using a questionnaire
    Time Frame
    1 year

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    15 Years
    Maximum Age & Unit of Time
    60 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: patients with acute (≤ 3 weeks after injury) Rockwood grade III-V ACJ dislocation Exclusion Criteria: Patients with associated coracoid fracture, associated rotator cuff tears or glenohumeral arthritis

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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    Coracoid Tunnel Widening After ACJ Tight Rope Fixation

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