Comparison of Single Tunnel Versus Double Tunnel Techniques for Coracoclavicular Stabilization in Acromioclavicular Joint Injuries

Официальное название

Comparison of Single Tunnel Versus Double Tunnel Techniques for Coracoclavicular Stabilization in Acromioclavicular Joint Injuries, A Randomized Controlled Trial

Обзор

The study conducted to compare both clinical and radiological outcomes comparing two techniques of Coracoclavicular-stabilization; single and double tunnel technique

Подробное описание

There are now over 150 techniques of operative treatment for Acromioclavicular joint injury. Despite no techniques used nowadays is recommended as gold standard treatment, most surgeons prefer Coracoclavicular-stabilization technique. Coracoclavicular-stabilization, providing favorable outcomes in many studies, regularly conducted with two surgical techniques which are single tunnel technique and double technique. Although, both techniques result in good biomechanic, patients underwent double tunnel technique report better clinical outcome. However, double tunnel technique compared to single tunnel technique is more challenging in surgical steps and risk intraoperative complications. This trial aims to compare both clinical and radiological outcomes of the two mentioned Coracoclavicular-stabilization techniques, in order to provide data to support treatment decision in patient with acute Acromioclavicular joint injury.

Вмешательства

• Процедура Coracoclavicular stabilization
  Single tunnel and double tunnel technique Coracoclavicular stabilization

Первичные конечные точки

• ACJI score [Срок оценки: ACJI score at preop, postop 3 months, 6 months and 1 year]

Вторичные конечные точки (1)

• CC-distance difference [Срок оценки: Measured at preop, postop 1 month, 3 months, 6 months and 1 year]

Критерии участия

Критерии включения

• Patients diagnosed with acute Acromioclavicular joint injury classified as Rockwood classification type III and above who willing to undergo CC-stabilization operative treatment
• Patients aged 18-45 years

Критерии исключения

• Patients who had experienced shoulder surgery at the same injured shoulder side
• Patients with shoulder pathology at the same injured shoulder side
• Patients with onset of Acromioclavicular joint injury for more than 3 weeks
• Patients who decided to discontinue participating the study

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

Простое слепое

Основная цель

Лечение

Центры проведения

Таиланд · 1 центр

• Queen Savang Memorial Hospital — Chon Buri

Публикации

• Eckl L, Vetter P, Bellmann F, Imiolczyk JP, Moroder P, Scheibel M. Management of Acute High-Grade Acromioclavicular Joint Dislocations: Comparable Clinical and Radiological Outcomes After Bidirectional Arthroscopic-Assisted Stabilization With the Single Low-Profile Suture Button Technique Versus Double-Suture Button Technique. Arthroscopy. 2023 Nov;39(11):2283-2290. doi: 10.1016/j.arthro.2023.05.0 PMID 37230186
• Jaspers M, Vueghs T, DE Mulder K, Vundelinckx B, Ruette P, VAN Raebroeckx A. Clavicular tunnel widening after acromioclavicular joint reconstruction: comparison between single and double clavicular tunnel techniques. Acta Orthop Belg. 2024 Mar;90(1):57-62. doi: 10.52628/90.1.12510. PMID 38669650
• Pill SG, Rush L, Arvesen J, Shanley E, Thigpen CA, Glomset JL, Longstaffe R, Kissenberth MJ. Systematic review of the treatment of acromioclavicular joint disruption comparing number of tunnels and graft type. J Shoulder Elbow Surg. 2020 Jul;29(7S):S92-S100. doi: 10.1016/j.jse.2020.04.008. PMID 32643614
• Hou Z, Graham J, Zhang Y, Strohecker K, Feldmann D, Bowen TR, Chen W, Smith W. Comparison of single and two-tunnel techniques during open treatment of acromioclavicular joint disruption. BMC Surg. 2014 Aug 15;14:53. doi: 10.1186/1471-2482-14-53. PMID 25127715
• Dumont GD, Russell RD, Knight JR, Hotchkiss WR, Pierce WA, Wilson PL, Robertson WJ. Impact of tunnels and tenodesis screws on clavicle fracture: a biomechanical study of varying coracoclavicular ligament reconstruction techniques. Arthroscopy. 2013 Oct;29(10):1604-7. doi: 10.1016/j.arthro.2013.07.257. Epub 2013 Aug 29. PMID 23993054
• Banffy MB, Uquillas C, Neumann JA, ElAttrache NS. Biomechanical Evaluation of a Single- Versus Double-Tunnel Coracoclavicular Ligament Reconstruction With Acromioclavicular Stabilization for Acromioclavicular Joint Injuries. Am J Sports Med. 2018 Apr;46(5):1070-1076. doi: 10.1177/0363546517752673. Epub 2018 Feb 13. PMID 29438625
• Gallagher CA, Blakeney W, Zellweger R. Acromioclavicular joint dislocation with associated brachial plexus injury. BMJ Case Rep. 2014 May 22;2014:bcr2013203299. doi: 10.1136/bcr-2013-203299. PMID 24855076
• Arrigoni P, Brady PC, Zottarelli L, Barth J, Narbona P, Huberty D, Koo SS, Adams CR, Parten P, Denard PJ, Burkhart SS. Associated lesions requiring additional surgical treatment in grade 3 acromioclavicular joint dislocations. Arthroscopy. 2014 Jan;30(1):6-10. doi: 10.1016/j.arthro.2013.10.006. PMID 24384271

Идентификаторы

NCT: NCT07399834 · 045/2568

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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