AC Joint DislocationNCT07399834
Comparison of Single Tunnel Versus Double Tunnel Techniques for Coracoclavicular Stabilization in Acromioclavicular Joint Injuries
A study testing Coracoclavicular stabilization in people with AC Joint Dislocation, run by Queen Savang Vadhana Memorial Hospital, Thailand at 1 site in Thailand.
Trial summary
The study conducted to compare both clinical and radiological outcomes comparing two techniques of Coracoclavicular-stabilization; single and double tunnel technique Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- AC Joint Dislocation
- What is being tested?
- Coracoclavicular stabilization
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 74 participants
- Where
- 1 siteThailand
- Study dates
- 15 Apr 2025to 15 Apr 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Thailand1 site
Queen Savang Memorial Hospital
Chon Buri, Changwat Chon Buri, 20110
About this study
Official title: 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
Read the 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.
- Conditions
- AC Joint Dislocation
- Being tested
- Coracoclavicular stabilization
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Coracoclavicular stabilizationProcedure or surgery
Single tunnel and double tunnel technique Coracoclavicular stabilization
| Study group | Role | What they receive |
|---|---|---|
| Single tunnel group | Other | Patients undergo single tunnel technique Coracoclavicular stabilization Receives: Procedure: Coracoclavicular stabilization |
| Double tunnel group | Other | Patients undergo double tunnel technique Coracoclavicular stabilization Receives: Procedure: Coracoclavicular stabilization |
What is being measured
The primary outcome is the main question the study is designed to answer.
ACJI score
Measured: ACJI score at preop, postop 3 months, 6 months and 1 year
Secondary outcomes (1)
CC-distance difference
CC-distance difference measured in bilateral Zanca view
Measured: Measured at preop, postop 1 month, 3 months, 6 months and 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2026
- Study start15 Apr 2025
- Primary completion15 Apr 2027 (estimated)
- Study completion15 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for AC Joint DislocationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patients with acute Acromioclavicular injury classified as Rockwood classification type III and above who willing to undergo the operative treatment were randomized to two groups; single tunnel group and double tunnel group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 74 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Queen Savang Vadhana Memorial Hospital, Thailand
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07399834
- Sponsor's protocol ID
- 045/2568
- Status last verified
- Feb 2026
- First submitted
- 20 Jan 2026
- Last updated
- 10 Feb 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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.2023.05.015. Epub 2023 May 23.
PubMed 37230186Jaspers 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.
PubMed 38669650Pill 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.
PubMed 32643614Hou 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.
PubMed 25127715Dumont 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.
PubMed 23993054Banffy 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.
PubMed 29438625Gallagher 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.
PubMed 24855076Arrigoni 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.
PubMed 24384271Tischer 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 Jan;37(1):136-9. doi: 10.1177/0363546508322891. Epub 2008 Aug 25.
PubMed 18725652Chillemi C, Franceschini V, Dei Giudici L, Alibardi A, Salate Santone F, Ramos Alday LJ, Osimani M. Epidemiology of isolated acromioclavicular joint dislocation. Emerg Med Int. 2013;2013:171609. doi: 10.1155/2013/171609. Epub 2013 Jan 28.
PubMed 234314524. 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.
Tauber M. Management of acute acromioclavicular joint dislocations: current concepts. Arch Orthop Trauma Surg. 2013 Jul;133(7):985-95. doi: 10.1007/s00402-013-1748-z. Epub 2013 Apr 30.
PubMed 23632779Fraser-Moodie JA, Shortt NL, Robinson CM. Injuries to the acromioclavicular joint. J Bone Joint Surg Br. 2008 Jun;90(6):697-707. doi: 10.1302/0301-620X.90B6.20704.
PubMed 18539661Berthold DP, Muench LN, Dyrna F, Mazzocca AD, Garvin P, Voss A, Scheiderer B, Siebenlist S, Imhoff AB, Beitzel K. Current concepts in acromioclavicular joint (AC) instability - a proposed treatment algorithm for acute and chronic AC-joint surgery. BMC Musculoskelet Disord. 2022 Dec 9;23(1):1078. doi: 10.1186/s12891-022-05935-0.
PubMed 36494652
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Single Tunnel Versus Double Tunnel Techniques for Coracoclavicular Stabilization in Acromioclavicular Joint Injuries, A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07399834
- Acronym / sponsor ID
- 045/2568
- Conditions
- AC Joint Dislocation
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 74 participants (estimated)
- Lead sponsor
- Queen Savang Vadhana Memorial Hospital, ThailandUniversity, hospital or other
- Study start
- 15 Apr 2025 (actual)
- Primary completion
- 15 Apr 2027 (estimated)
- Study completion
- 15 Apr 2027 (estimated)
- First posted
- 10 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Patients with acute Acromioclavicular injury classified as Rockwood classification type III and above who willing to undergo the operative treatment were randomized to two groups; single tunnel group and double tunnel group
| Arm | Type | Receives |
|---|---|---|
| Single tunnel group | Other | Procedure: Coracoclavicular stabilizationPatients undergo single tunnel technique Coracoclavicular stabilization |
| Double tunnel group | Other | Procedure: Coracoclavicular stabilizationPatients undergo double tunnel technique Coracoclavicular stabilization |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Coracoclavicular stabilizationSingle tunnel and double tunnel technique Coracoclavicular stabilization | Procedure or surgery | Double tunnel group, Single tunnel group |
Primary outcome
ACJI score
Time frame: ACJI score at preop, postop 3 months, 6 months and 1 year
1 secondary outcome
CC-distance difference
Time frame: Measured at preop, postop 1 month, 3 months, 6 months and 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2026.
- Background: PubMed 37230186Eckl 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.2023.05.015. Epub 2023 May 23.
- Background: PubMed 38669650Jaspers 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.
- Background: PubMed 32643614Pill 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.
- Background: PubMed 25127715Hou 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.
- Background: PubMed 23993054Dumont 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.
- Background: PubMed 29438625Banffy 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.
- Background: PubMed 24855076Gallagher 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.
- Background: PubMed 24384271Arrigoni 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.
- Background: PubMed 18725652Tischer 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 Jan;37(1):136-9. doi: 10.1177/0363546508322891. Epub 2008 Aug 25.
- Background: PubMed 23431452Chillemi C, Franceschini V, Dei Giudici L, Alibardi A, Salate Santone F, Ramos Alday LJ, Osimani M. Epidemiology of isolated acromioclavicular joint dislocation. Emerg Med Int. 2013;2013:171609. doi: 10.1155/2013/171609. Epub 2013 Jan 28.
- Background4. 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.
- Background: PubMed 23632779Tauber M. Management of acute acromioclavicular joint dislocations: current concepts. Arch Orthop Trauma Surg. 2013 Jul;133(7):985-95. doi: 10.1007/s00402-013-1748-z. Epub 2013 Apr 30.
- Individual participant dataSharing planned: Undecided
Related trials for AC Joint Dislocation
Not yet recruiting
Acute ACJ Dislocation Type (III&VI): CC Ligaments Reconstruction With AC Ligament Reconstruction vs. CC Ligaments Reconstruction With AC Temporary k Wire Fixation
Acromioclavicular Joint, Acromioclavicular Joint Dislocation
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Coracoclavicular stabilization in people with AC Joint Dislocation, run by Queen Savang Vadhana Memorial Hospital, Thailand at 1 site in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 10 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ACJI score (time frame: ACJI score at preop, postop 3 months, 6 months and 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07399834, which also lists 14 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Feb 2026.