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

Официальное название

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

Обзор

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?

Подробное описание

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?

Вмешательства

• Устройство 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.

Первичные конечные точки

• Acromioclavicular Joint Instability (ACJI) score [Срок оценки: 1 year post-operative]

Вторичные конечные точки (5)

• Coracoclavicular (CC) distance diference [Срок оценки: Postoperative day 1, 2weeks postop, 6weeks postop, 3months postop, 6 months postop, 1 year postop]
• Gleno-acromio-clavicular angle (GACA) difference [Срок оценки: 3months postop, 6 months postop, 1 year postop]
• Constant score [Срок оценки: 3months postop, 6 months postop, 1 year postop]
• DASH score [Срок оценки: 3months postop, 6 months postop, 1 year postop]
• VAS [Срок оценки: 3months postop, 6 months postop, 1 year postop]

Критерии участия

Критерии включения

• Age 18-45 years old
• Acute AC joint injury rockwood classification III, IV and V

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Таиланд · 1 центр

• Queen Savang Vadhana Memorial Hospital — Chon Buri

Публикации

• 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

Идентификаторы

NCT: NCT05844098 · Interventional

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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