Arthroscopic Versus Open Stabilization for Traumatic Shoulder Instability

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

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 Overview

• Status: Completed
• Conditions: Joint Instability; Shoulder Dislocation
• Intervention / Treatment: Procedure: Open stabilization; Procedure: Arthroscopic stabilization

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.

• Study Type: Interventional
• Enrollment (Actual): 194
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Alberta
    • Calgary, Alberta, Canada, T2N 1N4
      • University of Calgary Sport Medicine Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (ADULT, OLDER_ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Clinical:

  • Age 14 years or greater

  • Diagnosis of traumatic anterior shoulder instability, made by meeting all of the following:

    1. Radiographic evidence or documented physician assisted reduction of anterior shoulder dislocation following a traumatic injury.
    2. 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:

    1. Symptomatic (pain or discomfort) in inferior or posterior direction
    2. Ability to elicit unwanted posterior glenohumeral translation that reproduces symptoms with posterior apprehension tests, or posterior load and shift test
    3. 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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Open	Procedure: Open stabilization; 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.; Other Names: open shoulder stabilization; open Bankart reconstruction
ACTIVE_COMPARATOR: Arthroscopic	Procedure: Arthroscopic stabilization; 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.; Other Names: Scope stabilization; Arthroscopic reconstruction

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Western Ontario Shoulder Instability (WOSI) Index	Baseline, 3, 6, 12, 24 months post-operatively

Secondary Outcome Measures

Outcome Measure	Time Frame
American Shoulder and Elbow Society (ASES) score	Baseline, 3, 6, 12, 24 months post-operatively
Physical examination: range of motion, strength, stability	Baseline, 3, 6, 12, 24 months post-operatively
Return to sport or activity, return to work	Baseline, 3, 6, 12, 24 months post-operatively
Complications	Intra-operatively and up to 2 weeks post-operatively
Time to perform each procedure	Day of surgery
Economic cost of each procedure	Day of surgery

Collaborators and Investigators

• Sponsor: University of Calgary
• Collaborators: Canadian Orthopaedic Foundation; Calgary Orthopaedic Research and Education Fund; Calgary Regional Health Authority (CRHA)

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• Cash JD. Recent advances and perspectives on arthroscopic stabilization of the shoulder. Clin Sports Med. 1991 Oct;10(4):871-86.
• 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.

Study record dates

Study Major Dates

• Study Start: November 1, 2001
• Primary Completion (ACTUAL): December 1, 2010
• Study Completion (ACTUAL): December 1, 2013

Study Registration Dates

• First Submitted: November 8, 2005
• First Submitted That Met QC Criteria: November 8, 2005
• First Posted (ESTIMATE): November 9, 2005

Study Record Updates

• Last Update Posted (ESTIMATE): July 13, 2015
• Last Update Submitted That Met QC Criteria: July 9, 2015
• Last Verified: July 1, 2015

More Information

Terms related to this study

• Keywords: Arthroscopic; Anterior; Traumatic; Bankart; Shoulder instability; Bankart repair; Unidirectional; Open stabilization; Shoulder instability, traumatic; Anterior, unidirectional instability
• Additional Relevant MeSH Terms: Wounds and Injuries; Joint Diseases; Musculoskeletal Diseases; Shoulder Injuries; Joint Dislocations; Joint Instability; Shoulder Dislocation
• Other Study ID Numbers: 15740