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NCT Number: NCT05844098

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

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?

Recruiting

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Key information

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Queen Savang Vadhana Memorial Hospital

Chon Buri, 20110, Thailand

Location status: Recruiting

Location contact

Surasak Srimongkolpitak, M.D.

CONTACT

์Nachapong Sithiwichankit, M.D.

CONTACT

[email protected]

+66804570858

About this study

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?

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Acromioclavicular Joint Instability (ACJI) score

    Time frame: 1 year post-operative

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

Secondary outcomes

  1. Coracoclavicular (CC) distance diference

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

    Radiologic outcome

  2. Gleno-acromio-clavicular angle (GACA) difference

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

    Radiologic outcome

  3. Constant score

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

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

  4. DASH score

    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

  5. VAS

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

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

Study contacts

Contact information is provided by the study sponsor or research team.

Nachapong Sithiwichankit, M.D

CONTACT

[email protected]

+66038320200

Surasak Srimongkolpitak, M.D

CONTACT

+66038320200

Sponsors and collaborators

Lead sponsor

Queen Savang Vadhana Memorial Hospital, Thailand

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
May 6, 2023
Registry last updated
Oct 26, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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