- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07399834
Comparison of Single Tunnel Versus Double Tunnel Techniques for Coracoclavicular Stabilization in Acromioclavicular Joint Injuries
February 2, 2026 updated by: Queen Savang Vadhana Memorial Hospital, Thailand
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
Conditions
Intervention / Treatment
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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