Arthroscopic Versus Open Stabilization for Traumatic Shoulder Instability

NCT00251264 | Completed

• 1 other identifier: 15740
• Study Type: interventional
• Target: 194
• Locations: 1 country
• Sites: 1

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.

Conditions

Joint Instability; Shoulder Dislocation

Keywords

Shoulder instability; Traumatic; Anterior; Unidirectional; Open stabilization; Arthroscopic; Bankart repair; Shoulder instability, traumatic; Anterior, unidirectional instability; Bankart

Outcome Measures

Primary Outcomes (1)

• Western Ontario Shoulder Instability (WOSI) Index

  Baseline, 3, 6, 12, 24 months post-operatively

Secondary Outcomes (6)

• 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

Study Arms (2)

Open

ACTIVE COMPARATOR

Procedure: Open stabilization

Arthroscopic

ACTIVE COMPARATOR

Procedure: Arthroscopic stabilization

Interventions

Open stabilization PROCEDURE

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.

Also known as: open shoulder stabilization, open Bankart reconstruction

Open

Arthroscopic stabilization PROCEDURE

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.

Also known as: Scope stabilization, Arthroscopic reconstruction

Arthroscopic

Eligibility Criteria

• Age: 14 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Calgary: lead
• Calgary Regional Health Authority (CRHA): collaborator
• Calgary Orthopaedic Research and Education Fund: collaborator
• Canadian Orthopaedic Foundation: collaborator

Study Sites (1)

University of Calgary Sport Medicine Centre

Calgary, Alberta, T2N 1N4, Canada

Location

Related Publications (11)

• 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.

  PMID: 10424554 BACKGROUND

• 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.

  PMID: 14790098 BACKGROUND

• 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.

  PMID: 624747 BACKGROUND

• 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.

  PMID: 7810780 BACKGROUND

• 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.

  PMID: 7943514 BACKGROUND

• 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.

  PMID: 9850776 BACKGROUND

• 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.

  PMID: 2736008 BACKGROUND

• 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.

  PMID: 3300681 BACKGROUND

• 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.

  PMID: 2301687 BACKGROUND

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

  PMID: 1934102 BACKGROUND

• 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.

  PMID: 24599195 RESULT

MeSH Terms

Conditions

Joint Instability; Shoulder Dislocation

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases; Joint Dislocations; Wounds and Injuries; Shoulder Injuries

Study Officials

• Nicholas Mohtadi, MD, FRCSC

  University of Calgary Sport Medicine Centre

  PRINCIPAL INVESTIGATOR

• Robert Hollinshead, MD, FRCSC

  University of Calgary Sport Medicine Centre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor and Orthopaedic Surgeon

Study Record Dates

• First Submitted: November 8, 2005
• First Posted: November 9, 2005
• Study Start: November 1, 2001
• Primary Completion: December 1, 2010
• Study Completion: December 1, 2013
• Last Updated: July 13, 2015

Record last verified: 2015-07

Locations

CA (1)