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

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

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05844098
Enrollment
20
Registered
2023-05-06
Start date
2024-04-01
Completion date
2024-12-30
Last updated
2024-10-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acromioclavicular Joint Dislocation

Keywords

Arthroscopic assisted CC-stabilization, AC joint injury

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?

Interventions

DEVICEK-wire

K-wire No. 2.0 insertion was done additionally from arthroscopic assisted CC-stabilization by inserting K-wire from acromion process to distal clavicle.

Sponsors

Queen Savang Vadhana Memorial Hospital, Thailand
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Acromioclavicular Joint Instability (ACJI) score1 year post-operativeFunctional outcome, Rated from 0-100, higher score means better function of the shoulder

Secondary

MeasureTime frameDescription
Coracoclavicular (CC) distance diferencePostoperative day 1, 2weeks postop, 6weeks postop, 3months postop, 6 months postop, 1 year postopRadiologic outcome
Gleno-acromio-clavicular angle (GACA) difference3months postop, 6 months postop, 1 year postopRadiologic outcome
Constant score3months postop, 6 months postop, 1 year postopFunctional outcome, Score from 0-100, Higher score means better shoulder function
DASH score3months postop, 6 months postop, 1 year postopFunctional outcome, Score from 0-100, 0 means no disabillity, 100 means most severe disabillity
VAS3months postop, 6 months postop, 1 year postopFunctional outcome, Scale from 0-10, Lower score means better outcome

Countries

Thailand

Contacts

Primary ContactNachapong Sithiwichankit, M.D
leang1698@hotmail.com+66038320200
Backup ContactSurasak Srimongkolpitak, M.D
+66038320200

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026