Coracoid Tunnel Widening After ACJ Tight Rope Fixation

Orthopedic Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05504538
• Other study ID #: I-170518
• Status: Completed
• Phase: N/A
• Start date: July 2016
• Est. completion date: July 15, 2018

Study information

• Verified date: August 2022
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 23
• Est. completion date: July 15, 2018
• Est. primary completion date: July 15, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 15 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Musculoskeletal Diseases
• Orthopedic Devices Associated With Misadventures
• Orthopedic Disorder

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Coracoid tunnel diameter difference between immediate postoperative and final follow up	Radiological outcome using CT scans	1 year
Primary	Coraco-clavicular distance immediate postoperative and at final follow up	Radiological outcome using X-rays	1 year
Secondary	Constant-Murley shoulder score. Ranges from 0 representing worst outcome to 100 representing best outcome	Clinical score using a questionnaire	1 year
Secondary	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
Secondary	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