NCT07399834

Brief Summary

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

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
74

participants targeted

Target at P50-P75 for not_applicable

Timeline
11mo left

Started Apr 2025

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress53%
Apr 2025Apr 2027

Study Start

First participant enrolled

April 15, 2025

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

January 20, 2026

Completed
21 days until next milestone

First Posted

Study publicly available on registry

February 10, 2026

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 15, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 15, 2027

Last Updated

February 10, 2026

Status Verified

February 1, 2026

Enrollment Period

2 years

First QC Date

January 20, 2026

Last Update Submit

February 2, 2026

Conditions

AC Joint Dislocation

Outcome Measures

Primary Outcomes (1)

  • ACJI score

    ACJI score at preop, postop 3 months, 6 months and 1 year

Secondary Outcomes (1)

  • CC-distance difference

    Measured at preop, postop 1 month, 3 months, 6 months and 1 year

Study Arms (2)

Single tunnel group

OTHER

Patients undergo single tunnel technique Coracoclavicular stabilization

Procedure: Coracoclavicular stabilization

Double tunnel group

OTHER

Patients undergo double tunnel technique Coracoclavicular stabilization

Procedure: Coracoclavicular stabilization

Interventions

Coracoclavicular stabilizationPROCEDURE

Single tunnel and double tunnel technique Coracoclavicular stabilization

Double tunnel groupSingle tunnel group

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Queen Savang Memorial Hospital

Chon Buri, Changwat Chon Buri, 20110, Thailand

Location

Related Publications (14)

  • 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

    BACKGROUND

  • 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.

    BACKGROUND

  • 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.

    BACKGROUND

  • 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.

    BACKGROUND

  • 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.

    BACKGROUND

  • 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.

    BACKGROUND

  • 8. Gallagher CA, Blakeney W, Zellweger R. Acromioclavicular joint dislocation with associated brachial plexus injury. BMJ Case Rep. 2014;2014.

    BACKGROUND

  • 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.

    BACKGROUND

  • 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.

    BACKGROUND

  • 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.

    BACKGROUND

  • 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.

    BACKGROUND

  • 3. Tauber M. Management of acute acromioclavicular joint dislocations: current concepts. Arch Orthop Trauma Surg. 2013;133(7):985-95.

    BACKGROUND

  • 2. Fraser-Moodie JA, Shortt NL, Robinson CM. Injuries to the acromioclavicular joint. J Bone Joint Surg Br. 2008;90(6):697-707.

    BACKGROUND

  • 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.

    BACKGROUND

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 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
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 20, 2026

First Posted

February 10, 2026

Study Start

April 15, 2025

Primary Completion (Estimated)

April 15, 2027

Study Completion (Estimated)

April 15, 2027

Last Updated

February 10, 2026

Record last verified: 2026-02

Locations

TH(1)