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

Not Applicable
Recruiting
Conditions
Acromioclavicular Joint Dislocation
Interventions
Device: K-wire
Registration Number
NCT05844098
Lead Sponsor
Queen Savang Vadhana Memorial Hospital, Thailand
Brief Summary

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

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?

Recruitment & Eligibility

Status
RECRUITING
Sex
All
Target Recruitment
20
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 active 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

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
With K-wireK-wirearthroscopic assisted CC-stabilization with K-wire
Primary Outcome Measures
NameTimeMethod
Acromioclavicular Joint Instability (ACJI) score1 year post-operative

Functional outcome, Rated from 0-100, higher score means better function of the shoulder

Secondary Outcome Measures
NameTimeMethod
Gleno-acromio-clavicular angle (GACA) difference3months postop, 6 months postop, 1 year postop

Radiologic outcome

Constant score3months postop, 6 months postop, 1 year postop

Functional outcome, Score from 0-100, Higher score means better shoulder function

VAS3months postop, 6 months postop, 1 year postop

Functional outcome, Scale from 0-10, Lower score means better outcome

Coracoclavicular (CC) distance diferencePostoperative day 1, 2weeks postop, 6weeks postop, 3months postop, 6 months postop, 1 year postop

Radiologic outcome

DASH score3months postop, 6 months postop, 1 year postop

Functional outcome, Score from 0-100, 0 means no disabillity, 100 means most severe disabillity

Trial Locations

Locations (1)

Queen Savang Vadhana Memorial Hospital

🇹🇭

Chon Buri, Thailand

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