Queen Savang Vadhana Memorial Hospital
Chon Buri, 20110, Thailand
Location status: Recruiting
Location contact
Surasak Srimongkolpitak, M.D.
CONTACT
์Nachapong Sithiwichankit, M.D.
CONTACT
NCT Number: NCT05844098
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?
Interested in participating?
Request Info18 year–45 year
All sexes
Interventional
Not applicable
Chon Buri, 20110, Thailand
Location status: Recruiting
Surasak Srimongkolpitak, M.D.
CONTACT
์Nachapong Sithiwichankit, M.D.
CONTACT
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:
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
K-wire No. 2.0 insertion was done additionally from arthroscopic assisted CC-stabilization by inserting K-wire from acromion process to distal clavicle.
Time frame: 1 year post-operative
Functional outcome, Rated from 0-100, higher score means better function of the shoulder
Time frame: Postoperative day 1, 2weeks postop, 6weeks postop, 3months postop, 6 months postop, 1 year postop
Radiologic outcome
Time frame: 3months postop, 6 months postop, 1 year postop
Radiologic outcome
Time frame: 3months postop, 6 months postop, 1 year postop
Functional outcome, Score from 0-100, Higher score means better shoulder function
Time frame: 3months postop, 6 months postop, 1 year postop
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
Functional outcome, Scale from 0-10, Lower score means better outcome
Contact information is provided by the study sponsor or research team.
Nachapong Sithiwichankit, M.D
CONTACT
Surasak Srimongkolpitak, M.D
CONTACT
Queen Savang Vadhana Memorial Hospital, Thailand
Other
Arthroscopic Assisted CC Stabilization Alone VS Additional K-wire Fixation for Acute Acromioclavicular Joint Injury, A Randomized Controlled Trial
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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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