Coracoid Tunnel Widening After ACJ Tight Rope Fixation

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Orthopedic Disorder, Orthopedic Devices Associated With Misadventures

Intervention / Treatment
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* Procedure: arthroscopic fixation of Acute acromioclavicular joint injury using tight rope
* Device: Tight rope


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 15 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: patient with Acute acromioclavicular joint injury<br>patient with Acute acromioclavicular joint injury | Procedure: arthroscopic fixation of Acute acromioclavicular joint injury using tight rope<br>* arthroscopic fixation of Acute acromioclavicular joint injury using tight rope<br>Device: Tight rope<br>* Adjustable button device from Arthrex Naples USA<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Coracoid tunnel diameter difference between immediate postoperative and final follow up | Radiological outcome using CT scans | 1 year | 
| Coraco-clavicular distance immediate postoperative and at final follow up | Radiological outcome using X-rays | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Constant-Murley shoulder score. Ranges from 0 representing worst outcome to 100 representing best outcome | Clinical score using a questionnaire | 1 year | 
| 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 | 1 year | 
| 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 | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Acute acromioclavicular joint injury ., TightRope ., Coracoid tunnel dilatation., Loss of reduction.