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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-45
SponsorQueen Savang Vadhana Memorial Hospital, Thailand

About this trial

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?

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age 18-45 years old

Acute AC joint injury rockwood classification III, IV and V

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • K-wire

    Device

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

Treatment groups

20 Participants
are divided into 2 treatment groups
Group A: With K-wireExperimental treatment 1 intervention
Group B: No K-wireNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

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

Secondary outcomes

1

Coracoclavicular (CC) distance diference

Radiologic outcome

Time frame
Postoperative day 1, 2weeks postop, 6weeks postop, 3months postop, 6 months postop, 1 year postop
2

Gleno-acromio-clavicular angle (GACA) difference

Radiologic outcome

Time frame
3months postop, 6 months postop, 1 year postop
3

Constant score

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

Time frame
3months postop, 6 months postop, 1 year postop
4

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

Other outcomes

Sponsors and contacts

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