Clincosm LogoSign in Get a demo

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

Sponsor
Queen Savang Vadhana Memorial Hospital, Thailand (Other)
Overall Status
Recruiting
CT.gov ID
NCT05844098
Collaborator
(none)
20
Enrollment
1
Location
2
Arms
25
Anticipated Duration (Months)
0.8
Patients Per Site Per Month

Study Details

Study Description

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?
Condition or Disease Intervention/Treatment Phase
  • Device: K-wire
 N/A

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?

Study Design

Study Type:
Interventional
Anticipated Enrollment :
20 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Arthroscopic Assisted CC Stabilization Alone VS Additional K-wire Fixation for Acute Acromioclavicular Joint Injury, A Randomized Controlled Trial
Actual Study Start Date :
Apr 1, 2022
Anticipated Primary Completion Date :
Mar 31, 2024
Anticipated Study Completion Date :
Apr 30, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: With K-wire

arthroscopic assisted CC-stabilization with K-wire

Device: K-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.
No Intervention: No K-wire

arthroscopic assisted CC-stabilization

Outcome Measures

Primary Outcome Measures

  1. Acromioclavicular Joint Instability (ACJI) score [1 year post-operative]

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

Secondary Outcome Measures

  1. Coracoclavicular (CC) distance diference [Postoperative day 1, 2weeks postop, 6weeks postop, 3months postop, 6 months postop, 1 year postop]

    Radiologic outcome

  2. Gleno-acromio-clavicular angle (GACA) difference [3months postop, 6 months postop, 1 year postop]

    Radiologic outcome

  3. Constant score [3months postop, 6 months postop, 1 year postop]

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

  4. DASH score [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 [3months postop, 6 months postop, 1 year postop]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 45 Years
Sexes Eligible for Study:
All
Accepts 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 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Queen Savang Vadhana Memorial Hospital Chon Buri Thailand 20110

Sponsors and Collaborators

  • Queen Savang Vadhana Memorial Hospital, Thailand

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Queen Savang Vadhana Memorial Hospital, Thailand
ClinicalTrials.gov Identifier:
NCT05844098
Other Study ID Numbers:
  • Interventional
First Posted:
May 6, 2023
Last Update Posted:
May 6, 2023
Last Verified:
May 1, 2023
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Queen Savang Vadhana Memorial Hospital, Thailand
Arthroscopic assisted CC-stabilization
AC joint injury
Additional relevant MeSH terms:
Joint Dislocations

Study Results

No Results Posted as of May 6, 2023