Arthroscopic Versus Open Stabilization for Traumatic Shoulder Instability
Arthroscopic Versus Open Stabilization for Traumatic Shoulder Instability
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.
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.
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)