Coracoid Tunnel Widening After ACJ Tight Rope Fixation

NCT ID: NCT05504538

Last Updated: 2022-08-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

23 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-07-31

Study Completion Date

2018-07-15

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Orthopedic Disorder Orthopedic Devices Associated With Misadventures

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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patient with Acute acromioclavicular joint injury

patient with Acute acromioclavicular joint injury

Group Type EXPERIMENTAL

arthroscopic fixation of Acute acromioclavicular joint injury using tight rope

Intervention Type PROCEDURE

arthroscopic fixation of Acute acromioclavicular joint injury using tight rope

Tight rope

Intervention Type DEVICE

Adjustable button device from Arthrex Naples USA

Interventions

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arthroscopic fixation of Acute acromioclavicular joint injury using tight rope

arthroscopic fixation of Acute acromioclavicular joint injury using tight rope

Intervention Type PROCEDURE

Tight rope

Adjustable button device from Arthrex Naples USA

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

15 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Cairo University

OTHER

Sponsor Role lead

Responsible Party

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Mohamed Refaat Waly

Principal investigator, Consultant of Trauma and Orthopedics

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

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I-170518

Identifier Type: -

Identifier Source: org_study_id

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