Coracoid Tunnel Widening After ACJ Tight Rope Fixation

The Correlation Between Coracoid Tunnel Dilatation and Loss of Reduction After Arthroscopic Acromioclavicular Fixation Using Tightrope System, A CT Based Study

studying coracoid tunnel widening after arthroscopic fixation of acute acromioclavicular joint (ACJ) dislocation using TightRope system and its correlation with loss of reduction and the functional scores.

Study Overview

• Status: Completed
• Conditions: Orthopedic Disorder; Orthopedic Devices Associated With Misadventures
• Intervention / Treatment: Procedure: arthroscopic fixation of Acute acromioclavicular joint injury using tight rope; Device: Tight rope

Detailed Description

Abstract Purpose: To detect coracoid tunnel widening after arthroscopic fixation of acute acromioclavicular joint (ACJ) dislocation using TightRope system and its correlation with loss of reduction and the functional scores.

Methods: From July 2016 to Dec 2018, a prospective study was performed at our hospital. Twenty-three patients with acute grade III-V ACJ dislocation were included in the study. Arthroscopic double tight-rope repair of the ACJ was performed. Coracoid tunnel widening was measured by computed tomography (CT) and coraco-clavicular distance was measured on the x-ray immediately post-operative and at 12 months. Constant Shoulder Score, Oxford Shoulder Score, Nottingham Clavicle Score and Visual analogue scale were used as outcome measures at 12 months.

Level of evidence IV Keywords Acute acromioclavicular joint injury . TightRope . Coracoid tunnel dilatation. Loss of reduction.

• Study Type: Interventional
• Enrollment (Actual): 23
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 15 years to 60 years (ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• patients with acute (≤ 3 weeks after injury) Rockwood grade III-V ACJ dislocation

Exclusion Criteria:

• Patients with associated coracoid fracture, associated rotator cuff tears or glenohumeral arthritis

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: patient with Acute acromioclavicular joint injury	Procedure: arthroscopic fixation of Acute acromioclavicular joint injury using tight rope; arthroscopic fixation of Acute acromioclavicular joint injury using tight rope; Device: Tight rope; Adjustable button device from Arthrex Naples USA

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Coracoid tunnel diameter difference between immediate postoperative and final follow up	Radiological outcome using CT scans	1 year
Coraco-clavicular distance immediate postoperative and at final follow up	Radiological outcome using X-rays	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Constant-Murley shoulder score. Ranges from 0 representing worst outcome to 100 representing best outcome	Clinical score using a questionnaire	1 year
Disability of arm shoulder and Hand score ( DASH score) highest is 100 which represents worst outcome while lowest is 0 representing best possible outcome	Clinical score using a questionnaire	1 year
Oxford Shoulder score, a questionnaire of 12 questions each scores from 1 to 5. 1 being the fewest symptoms, 5 being the worst. The total score is 60 marks, the higher the score the worse the outcomes	Clinical score using a questionnaire	1 year

Collaborators and Investigators

• Sponsor: Cairo University

Study record dates

Study Major Dates

• Study Start (ACTUAL): July 1, 2016
• Primary Completion (ACTUAL): July 15, 2018
• Study Completion (ACTUAL): July 15, 2018

Study Registration Dates

• First Submitted: August 2, 2022
• First Submitted That Met QC Criteria: August 15, 2022
• First Posted (ACTUAL): August 17, 2022

Study Record Updates

• Last Update Posted (ACTUAL): August 19, 2022
• Last Update Submitted That Met QC Criteria: August 17, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Keywords: Acute acromioclavicular joint injury .; TightRope .; Coracoid tunnel dilatation.; Loss of reduction.
• Additional Relevant MeSH Terms: Musculoskeletal Diseases
• Other Study ID Numbers: I-170518

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: Yes
• product manufactured in and exported from the U.S.: Yes