Clinical trial NCT00251264: 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
Overall status: COMPLETED
Phase: NA
Conditions: Joint Instability
Shoulder Dislocation
Keywords: Shoulder instability
Traumatic
Anterior
Unidirectional
Open stabilization
Arthroscopic
Bankart repair
Shoulder instability, traumatic
Anterior, unidirectional instability
Bankart
Lead sponsor: University of Calgary
Sponsor class: OTHER
Collaborators: name: Calgary Regional Health Authority (CRHA)
name: Calgary Orthopaedic Research and Education Fund
name: Canadian Orthopaedic Foundation
First posted: 2005-11-09
Enrollment: 194
Sex: ALL
Minimum age (years): 14
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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)

Primary outcomes:
measure: Western Ontario Shoulder Instability (WOSI) Index
timeFrame: Baseline, 3, 6, 12, 24 months post-operatively
Secondary outcomes:
measure: American Shoulder and Elbow Society (ASES) score
timeFrame: Baseline, 3, 6, 12, 24 months post-operatively
measure: Physical examination: range of motion, strength, stability
timeFrame: Baseline, 3, 6, 12, 24 months post-operatively
measure: Return to sport or activity, return to work
timeFrame: Baseline, 3, 6, 12, 24 months post-operatively
measure: Complications
timeFrame: Intra-operatively and up to 2 weeks post-operatively
measure: Time to perform each procedure
timeFrame: Day of surgery
measure: Economic cost of each procedure
timeFrame: Day of surgery
Other outcomes:
Locations:
city: Calgary
country: Canada
facility: University of Calgary Sport Medicine Centre
state: Alberta
Study officials:
affiliation: University of Calgary Sport Medicine Centre
name: Nicholas Mohtadi, MD, FRCSC
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Calgary Sport Medicine Centre
name: Robert Hollinshead, MD, FRCSC
role: PRINCIPAL_INVESTIGATOR
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