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Arthroscopic Versus Open Stabilization for Traumatic Shoulder Instability

Primary Purpose

Joint Instability, Shoulder Dislocation

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Open stabilization
Arthroscopic stabilization
Sponsored by
University of Calgary
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Joint Instability focused on measuring Shoulder instability, Traumatic, Anterior, Unidirectional, Open stabilization, Arthroscopic, Bankart repair, Shoulder instability, traumatic, Anterior, unidirectional instability, Bankart

Eligibility Criteria

14 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Clinical: Age 14 years or greater Diagnosis of traumatic anterior shoulder instability, made by meeting all of the following: Radiographic evidence or documented physician assisted reduction of anterior shoulder dislocation following a traumatic injury. Ability to elicit unwanted glenohumeral translation which reproduce symptoms with one of the following tests: anterior apprehension, relocation test, or anterior load and shift test Radiological: Closed growth plate on a standardized series of x-rays consisting of a minimum of an anteroposterior view, lateral in the scapular plane and an axillary view. Exclusion Criteria: Clinical: Diagnosis of multidirectional instability (MDI) or multidirectional laxity with anteroinferior instability (MDL-AII), made by two or more of: Symptomatic (pain or discomfort) in inferior or posterior direction Ability to elicit unwanted posterior glenohumeral translation that reproduces symptoms with posterior apprehension tests, or posterior load and shift test Positive sulcus sign of 1cm or greater that reproduces patient's clinical symptoms Previous surgery on the affected shoulder other than diagnostic arthroscopy Cases involving litigation Significant tenderness of acromioclavicular/sternoclavicular joints on affected side Confirmed connective tissue disorder (ie: Ehlers-Danlos, Marfan)

Sites / Locations

  • University of Calgary Sport Medicine Centre

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Open

Arthroscopic

Arm Description

Outcomes

Primary Outcome Measures

Western Ontario Shoulder Instability (WOSI) Index

Secondary Outcome Measures

American Shoulder and Elbow Society (ASES) score
Physical examination: range of motion, strength, stability
Return to sport or activity, return to work
Complications
Time to perform each procedure
Economic cost of each procedure

Full Information

First Posted
November 8, 2005
Last Updated
July 9, 2015
Sponsor
University of Calgary
Collaborators
Calgary Regional Health Authority (CRHA), Calgary Orthopaedic Research and Education Fund, Canadian Orthopaedic Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT00251264
Brief Title
Arthroscopic Versus Open Stabilization for Traumatic Shoulder Instability
Official Title
Arthroscopic Versus Open Stabilization of Traumatic Unidirectional Anterior Shoulder Instability: A Randomized Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
July 2015
Overall Recruitment Status
Completed
Study Start Date
November 2001 (undefined)
Primary Completion Date
December 2010 (Actual)
Study Completion Date
December 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Calgary
Collaborators
Calgary Regional Health Authority (CRHA), Calgary Orthopaedic Research and Education Fund, Canadian Orthopaedic Foundation

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.
Detailed Description
Shoulder instability most commonly affects people in the late teens to mid thirties, which are the most active years, recreational and vocational. The resulting disability, time lost from work, as well as the effect on an individual's quality of life represent a significant clinical problem for the population and for the healthcare system. The normal anatomy in the unstable shoulder can be restored using arthroscopic or open surgical stabilization techniques. There is considerable controversy surrounding the issue of arthroscopic versus open shoulder stabilization. Advocates of arthroscopic procedures cite the following as advantages: faster recovery, less post operative pain, decreased operative time, improved cosmetics, greater return of shoulder motion and the more accurate identification of intraarticular pathology. Those in favor of an open procedure cite superior long term results showing fewer recurrences with an open stabilization. There are few published reports directly comparing arthroscopic versus open shoulder stabilization repairs. It is also difficult to compare the results of existing studies as they report on heterogeneous patient populations, using a variety of techniques on mixed pathologies, using different outcome scales and variable definitions of success and failure. This study will address this controversial issue by comparing the disease-specific quality of life outcomes in patients with traumatic unidirectional anterior shoulder instability undergoing an arthroscopic versus an open stabilization procedure. This study is designed as a prospective randomized clinical trial with a second prospective analytical cohort study arm. In the randomized arm, patients are assigned to arthroscopic or open surgery based on varied block, computer-generated randomization. The expertise-based randomization method is used in this study, whereby the surgeons perform either arthroscopic or open surgery, but not both. Therefore, a patient is not only randomized to a treatment group, but is also assigned to the expert surgeon for that treatment. Patients in the prospective analytical cohort study arm of the trial undergo shoulder stabilization (open or arthroscopic) with any surgeon and complete the same follow-up visits, however they have not been randomized. The outcomes of the prospective cohort will be compared to those of the randomized arm to determine if the expertise-based randomization method has an effect on patient outcome. Disease-specific quality of life is assessed using the validated Western Ontario Shoulder Instability (WOSI) Index. The index has 21 questions divided into 4 categories: physical symptoms, sport/recreation/work, lifestyle and emotions. This self-administered questionnaire utilizes a 100mm visual analog scale format to provide an overall score out of 100. A lower score reflects a better quality of life.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Joint Instability, Shoulder Dislocation
Keywords
Shoulder instability, Traumatic, Anterior, Unidirectional, Open stabilization, Arthroscopic, Bankart repair, Shoulder instability, traumatic, Anterior, unidirectional instability, Bankart

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
194 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Open
Arm Type
Active Comparator
Arm Title
Arthroscopic
Arm Type
Active Comparator
Intervention Type
Procedure
Intervention Name(s)
Open stabilization
Other Intervention Name(s)
open shoulder stabilization, open Bankart reconstruction
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Arthroscopic stabilization
Other Intervention Name(s)
Scope stabilization, Arthroscopic reconstruction
Intervention Description
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.
Primary Outcome Measure Information:
Title
Western Ontario Shoulder Instability (WOSI) Index
Time Frame
Baseline, 3, 6, 12, 24 months post-operatively
Secondary Outcome Measure Information:
Title
American Shoulder and Elbow Society (ASES) score
Time Frame
Baseline, 3, 6, 12, 24 months post-operatively
Title
Physical examination: range of motion, strength, stability
Time Frame
Baseline, 3, 6, 12, 24 months post-operatively
Title
Return to sport or activity, return to work
Time Frame
Baseline, 3, 6, 12, 24 months post-operatively
Title
Complications
Time Frame
Intra-operatively and up to 2 weeks post-operatively
Title
Time to perform each procedure
Time Frame
Day of surgery
Title
Economic cost of each procedure
Time Frame
Day of surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
14 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Clinical: Age 14 years or greater Diagnosis of traumatic anterior shoulder instability, made by meeting all of the following: Radiographic evidence or documented physician assisted reduction of anterior shoulder dislocation following a traumatic injury. Ability to elicit unwanted glenohumeral translation which reproduce symptoms with one of the following tests: anterior apprehension, relocation test, or anterior load and shift test Radiological: Closed growth plate on a standardized series of x-rays consisting of a minimum of an anteroposterior view, lateral in the scapular plane and an axillary view. Exclusion Criteria: Clinical: Diagnosis of multidirectional instability (MDI) or multidirectional laxity with anteroinferior instability (MDL-AII), made by two or more of: Symptomatic (pain or discomfort) in inferior or posterior direction Ability to elicit unwanted posterior glenohumeral translation that reproduces symptoms with posterior apprehension tests, or posterior load and shift test Positive sulcus sign of 1cm or greater that reproduces patient's clinical symptoms Previous surgery on the affected shoulder other than diagnostic arthroscopy Cases involving litigation Significant tenderness of acromioclavicular/sternoclavicular joints on affected side Confirmed connective tissue disorder (ie: Ehlers-Danlos, Marfan)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nicholas Mohtadi, MD, FRCSC
Organizational Affiliation
University of Calgary Sport Medicine Centre
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Robert Hollinshead, MD, FRCSC
Organizational Affiliation
University of Calgary Sport Medicine Centre
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Calgary Sport Medicine Centre
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2N 1N4
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
10424554
Citation
Kirkley A, Griffin S, Richards C, Miniaci A, Mohtadi N. Prospective randomized clinical trial comparing the effectiveness of immediate arthroscopic stabilization versus immobilization and rehabilitation in first traumatic anterior dislocations of the shoulder. Arthroscopy. 1999 Jul-Aug;15(5):507-14. doi: 10.1053/ar.1999.v15.015050.
Results Reference
background
PubMed Identifier
14790098
Citation
McLAUGHLIN HL, CAVALLARO WU. Primary anterior dislocation of the shoulder. Am J Surg. 1950 Nov 15;80(6):615-21; passim. doi: 10.1016/0002-9610(50)90581-2. No abstract available.
Results Reference
background
PubMed Identifier
624747
Citation
Rowe CR, Patel D, Southmayd WW. The Bankart procedure: a long-term end-result study. J Bone Joint Surg Am. 1978 Jan;60(1):1-16.
Results Reference
background
PubMed Identifier
7810780
Citation
Arciero RA, Wheeler JH, Ryan JB, McBride JT. Arthroscopic Bankart repair versus nonoperative treatment for acute, initial anterior shoulder dislocations. Am J Sports Med. 1994 Sep-Oct;22(5):589-94. doi: 10.1177/036354659402200504.
Results Reference
background
PubMed Identifier
7943514
Citation
Green MR, Christensen KP. Magnetic resonance imaging of the glenoid labrum in anterior shoulder instability. Am J Sports Med. 1994 Jul-Aug;22(4):493-8. doi: 10.1177/036354659402200410.
Results Reference
background
PubMed Identifier
9850776
Citation
Kirkley A, Griffin S, McLintock H, Ng L. The development and evaluation of a disease-specific quality of life measurement tool for shoulder instability. The Western Ontario Shoulder Instability Index (WOSI). Am J Sports Med. 1998 Nov-Dec;26(6):764-72. doi: 10.1177/03635465980260060501.
Results Reference
background
PubMed Identifier
2736008
Citation
Hawkins RB. Arthroscopic stapling repair for shoulder instability: a retrospective study of 50 cases. Arthroscopy. 1989;5(2):122-8. doi: 10.1016/0749-8063(89)90007-8.
Results Reference
background
PubMed Identifier
3300681
Citation
Morgan CD, Bodenstab AB. Arthroscopic Bankart suture repair: technique and early results. Arthroscopy. 1987;3(2):111-22. doi: 10.1016/s0749-8063(87)80027-0.
Results Reference
background
PubMed Identifier
2301687
Citation
Baker CL, Uribe JW, Whitman C. Arthroscopic evaluation of acute initial anterior shoulder dislocations. Am J Sports Med. 1990 Jan-Feb;18(1):25-8. doi: 10.1177/036354659001800104.
Results Reference
background
PubMed Identifier
1934102
Citation
Cash JD. Recent advances and perspectives on arthroscopic stabilization of the shoulder. Clin Sports Med. 1991 Oct;10(4):871-86.
Results Reference
background
PubMed Identifier
24599195
Citation
Mohtadi NG, Chan DS, Hollinshead RM, Boorman RS, Hiemstra LA, Lo IK, Hannaford HN, Fredine J, Sasyniuk TM, Paolucci EO. A randomized clinical trial comparing open and arthroscopic stabilization for recurrent traumatic anterior shoulder instability: two-year follow-up with disease-specific quality-of-life outcomes. J Bone Joint Surg Am. 2014 Mar 5;96(5):353-60. doi: 10.2106/JBJS.L.01656.
Results Reference
result

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Arthroscopic Versus Open Stabilization for Traumatic Shoulder Instability

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