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

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

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

Study Overview

Status

Enrolling by invitation

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.

Study Type

Interventional

Enrollment (Estimated)

74

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Changwat Chon Buri
      • Chon Buri, Changwat Chon Buri, Thailand, 20110
        • Queen Savang Memorial Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Single tunnel group
Patients undergo single tunnel technique Coracoclavicular stabilization
Single tunnel and double tunnel technique Coracoclavicular stabilization
Other: Double tunnel group
Patients undergo double tunnel technique Coracoclavicular stabilization
Single tunnel and double tunnel technique Coracoclavicular stabilization

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
ACJI score
Time Frame: ACJI score at preop, postop 3 months, 6 months and 1 year
ACJI score at preop, postop 3 months, 6 months and 1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
CC-distance difference
Time Frame: Measured at preop, postop 1 month, 3 months, 6 months and 1 year
CC-distance difference measured in bilateral Zanca view
Measured at preop, postop 1 month, 3 months, 6 months and 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

  • 14. Larissa E, Philipp V, Frederik B, 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;39(11):2283-2290
  • 13. Jaspers M, Vueghs T, K DEM, Vundelinckx B, Ruette P, A VANR. Clavicular tunnel widening after acromioclavicular joint reconstruction: comparison between single and double clavicular tunnel techniques. Acta Orthop Belg. 2024;90(1):57-62.
  • 12. Pill SG, Rush L, Arvesen J, Shanley E, Thigpen CA, Glomset JL, et al. Systematic review of the treatment of acromioclavicular joint disruption comparing number of tunnels and graft type. J Shoulder Elbow Surg. 2020;29(7S):S92-S100.
  • 11. Hou Z, Graham J, Zhang Y, Strohecker K, Feldmann D, Bowen TR, et al. Comparison of single and two-tunnel techniques during open treatment of acromioclavicular joint disruption. BMC Surg. 2014;14:53.
  • 10. Dumont GD, Russell RD, Knight JR, Hotchkiss WR, Pierce WA, Wilson PL, et al. Impact of tunnels and tenodesis screws on clavicle fracture: a biomechanical study of varying coracoclavicular ligament reconstruction techniques. Arthroscopy. 2013;29(10):1604-7.
  • 9. 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;46(5):1070-644.
  • 8. Gallagher CA, Blakeney W, Zellweger R. Acromioclavicular joint dislocation with associated brachial plexus injury. BMJ Case Rep. 2014;2014.
  • 7. Arrigoni P, Brady PC, Zottarelli L, Barth J, Narbona P, Huberty D, et al. Associated lesions requiring additional surgical treatment in grade 3 acromioclavicular joint dislocations. Arthroscopy. 2014;30(1):6-10.
  • 6. Tischer T, Salzmann GM, El-Azab H, Vogt S, Imhoff AB. Incidence of associated injuries with acute acromioclavicular joint dislocations types III through V. Am J Sports Med. 2009;37(1):136-9.
  • 5. Chillemi C, Franceschini V, Dei Giudici L, Alibardi A, Salate Santone F, Ramos Alday LJ, et al. Epidemiology of isolated acromioclavicular joint dislocation. Emerg Med Int. 2013;2013:171609.
  • 4. Kiel J, Taqi M, Kaiser K. Acromioclavicular Joint Injury. StatPearls. Treasure Island (FL) ineligible companies. Disclosure: Muhammad Taqi declares no relevant financial relationships with ineligible companies. Disclosure: Kimberly Kaiser declares no relevant financial relationships with ineligible companies.2024.
  • 3. Tauber M. Management of acute acromioclavicular joint dislocations: current concepts. Arch Orthop Trauma Surg. 2013;133(7):985-95.
  • 2. Fraser-Moodie JA, Shortt NL, Robinson CM. Injuries to the acromioclavicular joint. J Bone Joint Surg Br. 2008;90(6):697-707.
  • 1. Berthold DP, Muench LN, Dyrna F, Mazzocca AD, Garvin P, Voss A, et al. Current concepts in acromioclavicular joint (AC) instability - a proposed treatment algorithm for acute and chronic AC-joint surgery. BMC Musculoskelet Disord. 2022;23(1):1078.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 15, 2025

Primary Completion (Estimated)

April 15, 2027

Study Completion (Estimated)

April 15, 2027

Study Registration Dates

First Submitted

January 20, 2026

First Submitted That Met QC Criteria

February 2, 2026

First Posted (Actual)

February 10, 2026

Study Record Updates

Last Update Posted (Actual)

February 10, 2026

Last Update Submitted That Met QC Criteria

February 2, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Other Study ID Numbers

  • 045/2568

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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