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

October 23, 2024 updated by: Queen Savang Vadhana Memorial Hospital, Thailand

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Surasak Srimongkolpitak, M.D
  • Phone Number: +66038320200

Study Locations

  • Thailand
      • Chon Buri, Thailand, 20110
        • Recruiting
        • Queen Savang Vadhana Memorial Hospital
        • Contact:
        • Contact:
          • Surasak Srimongkolpitak, M.D.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
1 year post-operative

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Coracoclavicular (CC) distance diference
Time Frame: Postoperative day 1, 2weeks postop, 6weeks postop, 3months postop, 6 months postop, 1 year postop
Radiologic outcome
Postoperative day 1, 2weeks postop, 6weeks postop, 3months postop, 6 months postop, 1 year postop
Gleno-acromio-clavicular angle (GACA) difference
Time Frame: 3months postop, 6 months postop, 1 year postop
Radiologic outcome
3months postop, 6 months postop, 1 year postop
Constant score
Time Frame: 3months postop, 6 months postop, 1 year postop
Functional outcome, Score from 0-100, Higher score means better shoulder function
3months postop, 6 months postop, 1 year postop
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
3months postop, 6 months postop, 1 year postop
VAS
Time Frame: 3months postop, 6 months postop, 1 year postop
Functional outcome, Scale from 0-10, Lower score means better outcome
3months postop, 6 months postop, 1 year postop

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Queen Savang Vadhana Memorial Hospital, Thailand

Investigators

  • Principal Investigator: Nachapong Sithiwichankit, MD, QSMVH

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2024

Primary Completion (Estimated)

October 30, 2024

Study Completion (Estimated)

December 30, 2024

Study Registration Dates

First Submitted

February 16, 2023

First Submitted That Met QC Criteria

May 2, 2023

First Posted (Actual)

May 6, 2023

Study Record Updates

Last Update Posted (Actual)

October 26, 2024

Last Update Submitted That Met QC Criteria

October 23, 2024

Last Verified

October 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Interventional (Oncolys BioPharma Inc)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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