Arthroscopic Assisted CC Stabilization Alone VS Additional K-wire Fixation for Acute Acromioclavicular Joint Injury

Study Overview
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Brief Summary
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This RCT study is designed for comparing functional outcomes and radioligic outcomes between intervention group (Arthroscopic assisted CC-stabilzation with additional K-wire fixation) and control group (Arthroscopic assisted CC-stabilzation alone) for acute ACJI. The main question it aims to answer is: - Does Arthroscopic assisted CC-stabilization with additional K-wire fixation provide different outcomes in functional outcomes, CC-distance and GACA difference compare with arthroscopic assisted CC-stabilization alone in acute acromioclavicular joint injury?

Detailed Description
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Acromioclavicular joint injury (ACJI) is one of the most common injury of shoulder joint. Most common mechanism of injury is from direct force apply to the affected shoulder, in adduction position, in acromion process area. Most of the intervention that have been used for treat ACJI are focused on pain control, maintain the strength of the joint, no limitation in daily life activity and full range of motion of affected shoulder. Operative treatment is indicated in ACJI Rockwood classification grade III, IV, V, and VI. Nowadays there are over 60 surgical techniques without gold standard. Arthroscopic assisted CC-stabilzation is one of the most popular technique that has been used for ACJI. This RCT study is designed for comparing functional outcomes (ACJI score, VAS, Constant score and DASH score) and radioligic outcomes (CC-distance difference, GACA difference) between intervention group (Arthroscopic assisted CC-stabilzation with additional K-wire fixation) and control group (Arthroscopic assisted CC-stabilzation alone) for acute ACJI. The main question it aims to answer is: - Does Arthroscopic assisted CC-stabilization with additional K-wire fixation provide different outcomes in functional outcomes, CC-distance and GACA difference compare with arthroscopic assisted CC-stabilization alone in acute acromioclavicular joint injury?

Official Title
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Arthroscopic Assisted CC Stabilization Alone VS Additional K-wire Fixation for Acute Acromioclavicular Joint Injury, A Randomized Controlled Trial

Conditions
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Acromioclavicular Joint Dislocation

Intervention / Treatment
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* Device: K-wire


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 18-45 years old Acute AC joint injury rockwood classification III, IV and V Exclusion Criteria: History of underwent previous ipsilateral shoulder surgery Specific associated ipsilateral injury (Rib fractures, clavicel fractures, scapula fractures and base of coracoid fractures) Onset of injury more than 3 weeks Cannot underwent arthroscopic assisted CC-stabilization surgery

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: With K-wire<br>arthroscopic assisted CC-stabilization with K-wire | Device: K-wire<br>* K-wire No. 2.0 insertion was done additionally from arthroscopic assisted CC-stabilization by inserting K-wire from acromion process to distal clavicle.<br>|
| No Intervention: No K-wire<br>arthroscopic assisted CC-stabilization | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Acromioclavicular Joint Instability (ACJI) score | Functional outcome, Rated from 0-100, higher score means better function of the shoulder | 1 year post-operative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Coracoclavicular (CC) distance diference | Radiologic outcome | Postoperative day 1, 2weeks postop, 6weeks postop, 3months postop, 6 months postop, 1 year postop | 
| Gleno-acromio-clavicular angle (GACA) difference | Radiologic outcome | 3months postop, 6 months postop, 1 year postop | 
| Constant score | Functional outcome, Score from 0-100, Higher score means better shoulder function | 3months postop, 6 months postop, 1 year postop | 
| DASH score | Functional outcome, Score from 0-100, 0 means no disabillity, 100 means most severe disabillity | 3months postop, 6 months postop, 1 year postop | 
| VAS | Functional outcome, Scale from 0-10, Lower score means better outcome | 3months postop, 6 months postop, 1 year postop | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Arthroscopic assisted CC-stabilization, AC joint injury