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Recruiting NCT05844098

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

No phase Interventional Acromioclavicular Joint Dislocation

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: K-wire.
Who it may be relevant to
Registry conditions: Acromioclavicular Joint Dislocation. Basic parameters: 18 years — 45 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Thailand
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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?

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?

Interventions

  • 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.

Primary outcome measures

  • Acromioclavicular Joint Instability (ACJI) score [Time frame: 1 year post-operative]
Secondary outcome measures (5)
  • Coracoclavicular (CC) distance diference [Time frame: 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]
  • Constant score [Time frame: 3months postop, 6 months postop, 1 year postop]
  • DASH score [Time frame: 3months postop, 6 months postop, 1 year postop]
  • VAS [Time frame: 3months postop, 6 months postop, 1 year postop]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

Thailand · 1 center
  • Queen Savang Vadhana Memorial Hospital — Chon Buri

Publications

  • Frank RM, Cotter EJ, Leroux TS, Romeo AA. Acromioclavicular Joint Injuries: Evidence-based Treatment. J Am Acad Orthop Surg. 2019 Sep 1;27(17):e775-e788. doi: 10.5435/JAAOS-D-17-00105. PMID 31008872
  • Goldenberg MM. Analysis of the inhibitory innervation of the isolated gerbil colon. Arch Int Pharmacodyn Ther. 1968 Oct;175(2):347-64. No abstract available. PMID 5702953
  • Beitzel K, Mazzocca AD, Bak K, Itoi E, Kibler WB, Mirzayan R, Imhoff AB, Calvo E, Arce G, Shea K; Upper Extremity Committee of ISAKOS. ISAKOS upper extremity committee consensus statement on the need for diversification of the Rockwood classification for acromioclavicular joint injuries. Arthroscopy. 2014 Feb;30(2):271-8. doi: 10.1016/j.arthro.2013.11.005. PMID 24485119
  • Nolte PC, Lacheta L, Dekker TJ, Elrick BP, Millett PJ. Optimal Management of Acromioclavicular Dislocation: Current Perspectives. Orthop Res Rev. 2020 Mar 5;12:27-44. doi: 10.2147/ORR.S218991. eCollection 2020. PMID 32184680
  • Aliberti GM, Kraeutler MJ, Trojan JD, Mulcahey MK. Horizontal Instability of the Acromioclavicular Joint: A Systematic Review. Am J Sports Med. 2020 Feb;48(2):504-510. doi: 10.1177/0363546519831013. Epub 2019 Apr 23. PMID 31013137
  • Cisneros LN, Reiriz JS. Prevalence of remaining horizontal instability in high-grade acromioclavicular joint injuries surgically managed. Eur J Orthop Surg Traumatol. 2017 Apr;27(3):323-333. doi: 10.1007/s00590-016-1898-0. Epub 2017 Jan 5. PMID 28054147
  • Shin SJ, Kim NK. Complications after arthroscopic coracoclavicular reconstruction using a single adjustable-loop-length suspensory fixation device in acute acromioclavicular joint dislocation. Arthroscopy. 2015 May;31(5):816-24. doi: 10.1016/j.arthro.2014.11.013. Epub 2014 Dec 25. PMID 25543250
  • Tauber M, Koller H, Hitzl W, Resch H. Dynamic radiologic evaluation of horizontal instability in acute acromioclavicular joint dislocations. Am J Sports Med. 2010 Jun;38(6):1188-95. doi: 10.1177/0363546510361951. Epub 2010 Apr 1. PMID 20360606

Identifiers

NCT: NCT05844098 · Interventional

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗