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Completed

NCT Number: NCT05504538

Coracoid Tunnel Widening After ACJ Tight Rope Fixation

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.

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Key information

Conditions

Orthopedic Disorder Musculoskeletal Diseases Orthopedic Devices Associated With Misadventures

Age range

15 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

arthroscopic fixation of Acute acromioclavicular joint injury using tight rope

Procedure

arthroscopic fixation of Acute acromioclavicular joint injury using tight rope

Tight rope

Device

Adjustable button device from Arthrex Naples USA

Primary outcomes

  1. Coracoid tunnel diameter difference between immediate postoperative and final follow up

    Time frame: 1 year

    Radiological outcome using CT scans

  2. Coraco-clavicular distance immediate postoperative and at final follow up

    Time frame: 1 year

    Radiological outcome using X-rays

Secondary outcomes

  1. Constant-Murley shoulder score. Ranges from 0 representing worst outcome to 100 representing best outcome

    Time frame: 1 year

    Clinical score using a questionnaire

  2. Disability of arm shoulder and Hand score ( DASH score) highest is 100 which represents worst outcome while lowest is 0 representing best possible outcome

    Time frame: 1 year

    Clinical score using a questionnaire

  3. 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

    Time frame: 1 year

    Clinical score using a questionnaire

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

The Correlation Between Coracoid Tunnel Dilatation and Loss of Reduction After Arthroscopic Acromioclavicular Fixation Using Tightrope System, A CT Based Study

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Aug 17, 2022
Registry last updated
Aug 19, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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