Open Versus Arthroscopic Assisted Treatment of Acute Acromioclavicular Joint Disruption Using Suture Button Device

Compare the clinical and radiological outcome between the arthroscopic and open surgical repair using suture button device method in cases with acute AC joint disruption

Study Overview

• Status: Not yet recruiting
• Conditions: Acromioclavicular Joint Dislocation

Detailed Description

Acromioclavicular (AC) joint dislocation is a common shoulder injury, especially among athletes and has an estimated incidence of 17% of all shoulder injuries and30%-50% of athletic shoulder injuries ,In most cases, these are caused by a direct fall on the ipsilateral shoulder tip. The indirect mechanism of injury with an extended arm is rare, The Rockwood classification system is currently used and based on the degree and direction of the disrupted anatomy of the AC joint.

Despite the high prevalence of this injury, there is no consensus about its optimal treatment. A variety of surgical procedures are described in the literature, such as an augmented suture with absorbable materials, stabilization with Kirschner (K)-wires in combination with or without additional wire loops, hook plates, or the Bosworth screw, but none can be considered the gold standard of operative AC joint stabilization, another treatment option was offered by the Tight Rope system, This technique was developed as a minimally invasive procedure in the management of AC dislocations. Because of its minimally invasive approach, it reduces soft tissue damage and yields better cosmetic results.9 Also, there is no need for reoperation to remove the hardware that might screws, or plates. Moreover, the complications of hardware failure, like breakage, dislocations, or bone fractures, are minimized

• Study Type: Observational
• Enrollment (Estimated): 54

Contacts and Locations

• Study Contact: Name: Mohamed Adel abdelmajeed, residant; Phone Number: 01121650557; Email: mohamedadel@med.aun.edu.eg
• Study Contact Backup: Name: Hatem Galal Zaki, Prof.Dr; Phone Number: 01221762266; Email: Said.hgz@aun.edu.eg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients meeting the inclusion criteria and willing to take part in the study will be included investigators conducted an a priori test for sample size calculation using the G*Power 3.1.9.2 software. investigators assumed a CMS mean difference between the 2 groups of 16 points, a standard deviation of 20 points, an alpha of 0.05, and power (1 - b) of 80%; 21 subjects had to be included in each group. Our goal was to include 27 cases in each group to compensate for any lost subjects during the follow-up phase

Description

Inclusion Criteria:

• Age of 16 to 60 years
• Definite radiographic diagnosis of isolated Rockwood type IIIb(unstable), IV and type v acromioclavicular joint dislocation
• Time from injury to operation < 3 weeks
• Patient with complete at least 12-month follow-up assessments

Exclusion Criteria:

• . Age outside the range

  • Open injury, old injury (≥ 3 weeks since injury)
  • Injury caused by other diseases (tendinitis, metabolic, et al.), concurrent shoulder osteoarthritis, arthropathy or any fracture
  • Any previous operation of the injured limb
  • Incomplete data or follow-up < 12 months

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
group 1; open surgical repair using suture button device method in acute acromioclavicular joint disruption
group 2; arthroscopic assisted treatment of acute acromioclavicular joint disruption using suture button device

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Radiological evaluation using the true anteroposterior view of the shoulder	Radiological evaluation using the true anteroposterior view of the shoulder and AC projection (10 cephalic tilt with the beam centered over the AC joint)	preoperative, three month postoperative and six month postoperative

Collaborators and Investigators

• Sponsor: Assiut University

Publications and helpful links

General Publications

• Jeong JY, Chun YM. Treatment of acute high-grade acromioclavicular joint dislocation. Clin Shoulder Elb. 2020 Sep 1;23(3):159-165. doi: 10.5397/cise.2020.00150. eCollection 2020 Sep.
• Vijayan S, Kulkarni MS, Jain CP, Shetty S, Aroor MN, Rao SK. Bifocal Stabilisation of Acute Acromioclavicular Joint Dislocation using Suture Anchor and Temporary K-Wires: A Retrospective Analysis. Malays Orthop J. 2022 Nov;16(3):104-112. doi: 10.5704/MOJ.2211.016.
• Bezruchenko S, Dolhopolov O, Yarova M, Luchko R, Mazevych V. Clinical Evaluation and Instrumental Diagnostics in Acute Acromioclavicular Joint Dislocation. Ortop Traumatol Rehabil. 2022 Feb 28;24(1):1-12. doi: 10.5604/01.3001.0015.7800.
• Lu D, Wang T, Hong JJ, Chen H, Sun LJ. Acute acromioclavicular joint dislocation treated with tightrope : Mini-open versus percutaneous stabilization. Acta Orthop Belg. 2019 Dec;85(4):406-411.
• Liu X, Huangfu X, Zhao J. Arthroscopic treatment of acute acromioclavicular joint dislocation by coracoclavicular ligament augmentation. Knee Surg Sports Traumatol Arthrosc. 2015 May;23(5):1460-1466. doi: 10.1007/s00167-013-2800-9. Epub 2013 Dec 10.

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2024
• Primary Completion (Estimated): September 1, 2025
• Study Completion (Estimated): October 1, 2025

Study Registration Dates

• First Submitted: July 18, 2023
• First Submitted That Met QC Criteria: August 25, 2023
• First Posted (Actual): August 31, 2023

Study Record Updates

• Last Update Posted (Estimated): February 22, 2024
• Last Update Submitted That Met QC Criteria: February 21, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Joint Diseases; Musculoskeletal Diseases; Joint Dislocations
• Other Study ID Numbers: Acute AC Joint disruption

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No