CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 194 enrolled
Drug / intervention
Open stabilization +1 moreprocedure
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00251264
NCT00251264N/ACompleted

Arthroscopic Versus Open Stabilization of Traumatic Unidirectional Anterior Shoulder Instability: A Randomized Clinical Trial

University of Calgary·interventional·Posted Nov 9, 2005·Updated Jul 13, 2015

In Brief

A clinical study evaluating Open stabilization and Arthroscopic stabilization for Joint Instability and Shoulder Dislocation. Completed, enrolled 194 participants across 1 site.

Detailed Summary

The purpose of this study is to compare arthroscopic and open shoulder stabilization procedures by measuring the disease-specific quality of life outcome in patients with traumatic unidirectional anterior instability of the shoulder at 2 and 5 years. Hypothesis: There is no difference in disease-specific quality of life outcomes in patients with traumatic unidirectional anterior shoulder instability, undergoing an arthroscopic versus an open stabilization procedure.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesCanada

Timeline

N/ACompletedFinished
20022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedNov 9, 2005
Enrollment StartNov 1, 2001
Primary CompletionDec 1, 2010
Study CompletionDec 1, 2013
TodayJul 2, 2026
Enrollment to primary: 9.1 yearsPosted 20.6 years ago

Interventions

Open stabilizationprocedure

Following examination under anesthesia, a 5cm standard deltopectoral incision is made. Dissection is continued exploiting the deltopectoral internervous plane. The conjoined tendon is retracted medially. The underlying subscapularis tendon is identified and incised horizontally or split vertically in its midsubstance. If required for adequate exposure, the subscapularis split may be extended by incising the inferior component of the subscapularis tendon near its insertion on the lesser tuberosity. The shoulder is entered by performing a "T" shaped arthrotomy with retractors for full exposure of the glenoid. Shoulder pathology is addressed with suture anchor repair of any capsulolabral detachment (ie.Bankart lesion) and/ or a capsular plication for repair of capsular redundancy.

Arthroscopic stabilizationprocedure

With the examination under anesthesia completed, the arthroscope is introduced through a standard posterior arthroscopy portal. A diagnostic arthroscopy is performed and the intraarticular pathology identified and documented. Any labral detachment (i.e. Bankart lesion) is repaired using suture anchor fixation and arthroscopic tying techniques. Capsular redundancy is addressed with the use of thermal electrocapsulorrhaphy or arthroscopic suture repair of the redundant capsule. With the repair complete, 40 cc of 0.5% Bupivicaine is introduced into the joint. A sterile dressing is applied over the wounds and the operated shoulder placed in a shoulder immobilizer.