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

NCT06019260 | Not Yet Recruiting

• 1 other identifier: Acute AC Joint disruption
• Study Type: observational
• Target: 54
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Acromioclavicular Joint Dislocation

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

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

Eligibility Criteria

• Age: 16 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• 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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Assiut University: lead

Related Publications (5)

• 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.

  PMID: 33330252 BACKGROUND

• 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.

  PMID: 36589364 BACKGROUND

• 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.

  PMID: 35297375 BACKGROUND

• 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.

  PMID: 24318508 BACKGROUND

• 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.

  PMID: 32374229 BACKGROUND

Central Study Contacts

Mohamed Adel abdelmajeed, residant

CONTACT

01121650557; mohamedadel@med.aun.edu.eg

Hatem Galal Zaki, Prof.Dr

CONTACT

01221762266; Said.hgz@aun.edu.eg

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: resident doctor

Study Record Dates

• First Submitted: July 18, 2023
• First Posted: August 31, 2023
• Study Start: January 1, 2025
• Primary Completion: September 1, 2025
• Study Completion: October 1, 2025
• Last Updated: December 27, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share