Actively Recruiting

Phase Not Applicable
Age: 18Years - 45Years
All Genders
ID05844098

Arthroscopic Assisted Coracoclavicular Stabilization Alone Versus Additional K-wire Fixation for Acute Acromioclavicular Joint Injury: A Randomized Controlled Trial

Led by Queen Savang Vadhana Memorial Hospital, Thailand · Updated on 2024-10-26

20

Participants Needed

1

Research Sites

8 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating two surgical methods for treating acute acromioclavicular joint injury (ACJI), a common shoulder injury often caused by direct force to the shoulder. The study compares functional and radiologic outcomes between arthroscopic assisted coracoclavicular (CC) stabilization alone and the same procedure with additional K-wire fixation. The goal is to see if adding K-wire fixation changes recovery outcomes such as joint stability and shoulder function. Participants will be randomly assigned to one of two groups: one receiving arthroscopic assisted CC stabilization with an extra K-wire device inserted from the acromion process to the distal clavicle, and the other receiving only the arthroscopic assisted CC stabilization without K-wire. This device is used as an additional fixation tool. The study will assess outcomes over a year to compare effectiveness. During the study, participants will have their shoulder function measured using scores like ACJI, Constant, DASH, and pain levels (VAS) at multiple time points including 3, 6, and 12 months after surgery. Radiologic outcomes such as coracoclavicular distance and gleno-acromio-clavicular angle will be monitored at specific intervals from day 1 post-surgery up to one year. These assessments help track the joint stability and recovery progress throughout the follow-up period.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years - 45Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18-45 years old
  • Acute acromioclavicular joint injury classified as Rockwood grade III, IV, or V
Not Eligible

You will not qualify if you...

  • Previous surgery on the same side shoulder
  • Other active injuries on the same side such as rib, clavicle, scapula, or coracoid fractures
  • Injury onset more than 3 weeks ago
  • Unable to undergo arthroscopic assisted CC-stabilization surgery

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Surgery and Immediate Post-operative Care

Duration - Surgery day and immediate recovery period

Participants undergo arthroscopic assisted coracoclavicular stabilization surgery, with or without additional K-wire fixation, for acute acromioclavicular joint injury.

1 surgical procedure

Post-operative Follow-up

Duration - 1 year

Participants are followed after surgery to monitor recovery and assess functional and radiologic outcomes.

Visits on postoperative day 1, 2 weeks, 6 weeks, 3 months, 6 months, and 1 year

Trial Site Locations

Total: 1 location

1

Queen Savang Vadhana Memorial Hospital

Chon Buri, Thailand, 20110

Actively Recruiting

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Research Team

N

Nachapong Sithiwichankit, M.D

S

Surasak Srimongkolpitak, M.D

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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Published Research Related To This Trial

ISAKOS upper extremity committee consensus statement on the need for diversification of the Rockwood classification for acromioclavicular joint injuries.

Knut Beitzel, Augustus D Mazzocca, Klaus Bak...

https://pubmed.ncbi.nlm.nih.gov/24485119

Complications after arthroscopic coracoclavicular reconstruction using a single adjustable-loop-length suspensory fixation device in acute acromioclavicular joint dislocation.

Sang-Jin Shin, Nam-Ki Kim

https://pubmed.ncbi.nlm.nih.gov/25543250

Quantification of dynamic posterior translation in modified bilateral Alexander views and correlation with clinical and radiological parameters in patients with acute acromioclavicular joint instability.

Marvin Minkus, Carmen Hann, Markus Scheibel...

https://pubmed.ncbi.nlm.nih.gov/28417201

Acute high-grade acromioclavicular dislocations treated with triple button device (MINAR): Preliminary results.

José Antonio Cano-Martínez, Gregorio Nicolás-Serrano, Julio Bento-Gerard...

https://pubmed.ncbi.nlm.nih.gov/27663286