Arthroscopic Versus Open Stabilization for Traumatic Shoulder Instability

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
AHS Cancer Control Alberta
Calgary Orthopaedic Research and Education Fund (COREF)
Canadian Orthopaedic Foundation
Information provided by (Responsible Party):
Dr. Nicholas Mohtadi, University of Calgary
ClinicalTrials.gov Identifier:
NCT00251264
First received: November 8, 2005
Last updated: July 8, 2013
Last verified: July 2013
  Purpose

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.


Condition Intervention
Joint Instability
Shoulder Dislocation
Procedure: Open stabilization
Procedure: Arthroscopic stabilization

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Arthroscopic Versus Open Stabilization of Traumatic Unidirectional Anterior Shoulder Instability: A Randomized Clinical Trial

Resource links provided by NLM:


Further study details as provided by University of Calgary:

Primary Outcome Measures:
  • Western Ontario Shoulder Instability (WOSI) Index [ Time Frame: Baseline, 3, 6, 12, 24 months post-operatively ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • American Shoulder and Elbow Society (ASES) score [ Time Frame: Baseline, 3, 6, 12, 24 months post-operatively ] [ Designated as safety issue: No ]
  • Physical examination: range of motion, strength, stability [ Time Frame: Baseline, 3, 6, 12, 24 months post-operatively ] [ Designated as safety issue: No ]
  • Return to sport or activity, return to work [ Time Frame: Baseline, 3, 6, 12, 24 months post-operatively ] [ Designated as safety issue: No ]
  • Complications [ Time Frame: Intra-operatively and up to 2 weeks post-operatively ] [ Designated as safety issue: No ]
  • Time to perform each procedure [ Time Frame: Day of surgery ] [ Designated as safety issue: No ]
  • Economic cost of each procedure [ Time Frame: Day of surgery ] [ Designated as safety issue: No ]

Estimated Enrollment: 194
Study Start Date: November 2001
Estimated Study Completion Date: December 2013
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   14 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00251264

Locations
Canada, Alberta
University of Calgary Sport Medicine Centre
Calgary, Alberta, Canada, T2N 1N4
Sponsors and Collaborators
University of Calgary
AHS Cancer Control Alberta
Calgary Orthopaedic Research and Education Fund (COREF)
Canadian Orthopaedic Foundation
Investigators
Principal Investigator: Nicholas Mohtadi, MD, FRCSC University of Calgary Sport Medicine Centre
Principal Investigator: Robert Hollinshead, MD, FRCSC University of Calgary Sport Medicine Centre
  More Information

Publications:

Responsible Party: Dr. Nicholas Mohtadi, Clinical Professor and Orthopaedic Surgeon, University of Calgary
ClinicalTrials.gov Identifier: NCT00251264     History of Changes
Other Study ID Numbers: 15740
Study First Received: November 8, 2005
Last Updated: July 8, 2013
Health Authority: Canada: Health Canada

Keywords provided by University of Calgary:
Shoulder instability
Traumatic
Anterior
Unidirectional
Open stabilization
Arthroscopic
Bankart repair
Shoulder instability, traumatic
Anterior, unidirectional instability
Bankart

Additional relevant MeSH terms:
Dislocations
Joint Instability
Shoulder Dislocation
Wounds and Injuries
Joint Diseases
Musculoskeletal Diseases
Arm Injuries

ClinicalTrials.gov processed this record on April 14, 2014