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Enrolling by invitation NCT07399834

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

No phase Interventional AC 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: Coracoclavicular stabilization.
Who it may be relevant to
Registry conditions: AC 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 →
Official title

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

Overview

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

Detailed description

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.

Interventions

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

Primary outcome measures

  • ACJI score [Time frame: ACJI score at preop, postop 3 months, 6 months and 1 year]
Secondary outcome measures (1)
  • CC-distance difference [Time frame: Measured at preop, postop 1 month, 3 months, 6 months and 1 year]

Eligibility criteria

Inclusion criteria

  • 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

Exclusion criteria

  • 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

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
Single blind
Primary purpose
Treatment

Study locations

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

Publications

  • 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

Identifiers

NCT: NCT07399834 · 045/2568

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗