An interventional study of K-wire in Acromioclavicular Joint Dislocation, sponsored by Queen Savang Vadhana Memorial Hospital, Thailand. Recruiting at 1 site in Thailand. Open to participants aged 18 Years to 45 Years. Per ClinicalTrials.gov, last updated 2024-10-26.
Sponsored by Queen Savang Vadhana Memorial Hospital, Thailand · Not applicable, Interventional, and Treatment
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:
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:
98 studies on the registry are indexed under Joint Dislocations; 21 are open to participants now.
This study's planned enrollment of 20 is below the median of 50 across 60 interventional studies indexed under Joint Dislocations.
Browse Joint Dislocations studies →Queen Savang Vadhana Memorial Hospital, Thailand is the lead sponsor of 29 studies on the registry; 15 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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Exclusion Criteria:
arthroscopic assisted CC-stabilization with K-wire
Device: K-wire
arthroscopic assisted CC-stabilization
K-wire No. 2.0 insertion was done additionally from arthroscopic assisted CC-stabilization by inserting K-wire from acromion process to distal clavicle.
Acromioclavicular Joint Instability (ACJI) score
Functional outcome, Rated from 0-100, higher score means better function of the shoulder
Time frame: 1 year post-operative
Coracoclavicular (CC) distance diference
Radiologic outcome
Time frame: Postoperative day 1, 2weeks postop, 6weeks postop, 3months postop, 6 months postop, 1 year postop
Gleno-acromio-clavicular angle (GACA) difference
Radiologic outcome
Time frame: 3months postop, 6 months postop, 1 year postop
Constant score
Functional outcome, Score from 0-100, Higher score means better shoulder function
Time frame: 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
Time frame: 3months postop, 6 months postop, 1 year postop
VAS
Functional outcome, Scale from 0-10, Lower score means better outcome
Time frame: 3months postop, 6 months postop, 1 year postop
Started Apr 2024 (actual). Primary completion is estimated for Oct 2024, 6 months after the start.
Of 24 interventional studies with no phase under Joint Dislocations, half reached primary completion within 25 months of starting (the median), counting those still running; a quarter within 17 and three quarters within 68. This study's planned 6 months is below that.
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Queen Savang Vadhana Memorial Hospital, Thailand