Coracoid Tunnel Widening After ACJ Tight Rope Fixation

• Sponsor: Cairo University (Other)
• Overall Status: Completed
• CT.gov ID: NCT05504538
• Collaborator: (none)
• Enrollment: 23
• Arm: 1
• Actual Duration (Months): 24.4

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Orthopedic Disorder; Orthopedic Devices Associated With Misadventures	Procedure: arthroscopic fixation of Acute acromioclavicular joint injury using tight rope; Device: Tight rope	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 23 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: The Correlation Between Coracoid Tunnel Dilatation and Loss of Reduction After Arthroscopic Acromioclavicular Fixation Using Tightrope System, A CT Based Study
• Actual Study Start Date: Jul 1, 2016
• Actual Primary Completion Date: Jul 15, 2018
• Actual Study Completion Date: Jul 15, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: patient with Acute acromioclavicular joint injury 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

Outcome Measures

Primary Outcome Measures

1. Coracoid tunnel diameter difference between immediate postoperative and final follow up [1 year]

   Radiological outcome using CT scans

2. Coraco-clavicular distance immediate postoperative and at final follow up [1 year]

   Radiological outcome using X-rays

Secondary Outcome Measures

1. Constant-Murley shoulder score. Ranges from 0 representing worst outcome to 100 representing best outcome [1 year]

   Clinical score using a questionnaire

2. Disability of arm shoulder and Hand score ( DASH score) highest is 100 which represents worst outcome while lowest is 0 representing best possible outcome [1 year]

   Clinical score using a questionnaire

3. 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 [1 year]

   Clinical score using a questionnaire

Eligibility Criteria

Criteria

• Ages Eligible for Study: 15 Years to 60 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Cairo University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Mohamed Refaat Waly, Principal investigator, Consultant of Trauma and Orthopedics, Cairo University
• ClinicalTrials.gov Identifier: NCT05504538
• Other Study ID Numbers: I-170518
• First Posted: Aug 17, 2022
• Last Update Posted: Aug 19, 2022
• Last Verified: Aug 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• 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
• Keywords provided by Mohamed Refaat Waly, Principal investigator, Consultant of Trauma and Orthopedics, Cairo University: Acute acromioclavicular joint injury .; TightRope .; Coracoid tunnel dilatation.; Loss of reduction.
• Additional relevant MeSH terms: Musculoskeletal Diseases

Study Results

No Results Posted as of Aug 19, 2022