Arthroscopic Versus Open Stabilization for Traumatic Shoulder Instability
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.
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 Design
Allocation: Randomized, Control: Active Control, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
Conditions
Joint Instability
Intervention
Open stabilization, Arthroscopic stabilization
Location
University of Calgary Sport Medicine Centre
Calgary
Alberta
Canada
T2N 1N4
Status
Active, not recruiting
Source
University of Calgary
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT00251264
- Information obtained from ClinicalTrials.gov on July 15, 2010
Medical and Biotech [MESH] Definitions
Joint Instability
Lack of stability of a joint or joint prosthesis. Factors involved are intra-articular disease and integrity of extra-articular structures such as joint capsule, ligaments, and muscles.
Postpoliomyelitis Syndrome
A syndrome characterized by new neuromuscular symptoms that occur at least 15 years after clinical stability has been attained in patients with a prior history of symptomatic poliomyelitis. Clinical features include new muscular weakness and atrophy of the limbs, bulbar innervated musculature, and muscles of respiration, combined with excessive fatigue, joint pain, and reduced stamina. The process is marked by slow progression and periods of stabilization. (From Ann NY Acad Sci 1995 May 25;753:68-80)
Occlusal Adjustment
Selective grinding of occlusal surfaces of the teeth in an effort to eliminate premature contacts and occlusal interferences; to establish optimal masticatory effectiveness, stable occlusal relationships, direction of main occlusal forces, and efficient multidirectional patterns, to improve functional relations and to induce physiologic stimulation of the masticatory system; to eliminate occlusal trauma; to eliminate abnormal muscle tension; to aid in the stabilization of orthodontic results; to treat periodontal and temporomandibular joint problems; and in restorative procedures. (From Jablonski, Dictionary of Dentistry, 1992)
Dental Implantation, Endosseous, Endodontic
Insertion of a tapered rod through the root canal into the periapical osseous structure to lengthen the existing root and provide individual tooth stabilization.
Arthropathy, Neurogenic
Chronic progressive degeneration of the stress-bearing portion of a joint, with bizarre hypertrophic changes at the periphery. It is probably a complication of a variety of neurologic disorders, particularly TABES DORSALIS, involving loss of sensation, which leads to relaxation of supporting structures and chronic instability of the joint. (Dorland, 27th ed)
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