Electrothermal arthroscopic capsulorrhaphy (ETAC) was a technology introduced for orthopaedic surgery without good scientific clinical evidence supporting its use. This multicentre randomized clinical trial provides the scientific clinical evidence comparing ETAC to Open Inferior Capsular Shift (ICS), by measuring disease-specific quality of life at 2-years post-operatively, in patients with shoulder instability due to capsular redundancy. Fifty-four subjects (37 females and 17 males; mean age 23.3 years (SD = 6.9; 15–44 years) with multidirectional instability (MDI) or multidirectional laxity with antero-inferior instability (MDL-AII) were randomized intra-operatively to ETAC (n = 28) or Open ICS (n = 26) using concealed envelopes, computer-generated, variable block randomization with stratification by surgeon and type of instability. Outcomes were measured at baseline, 3 and 6 months, 1 and 2 years. The Western Ontario Shoulder Instability (WOSI) Index is a quality of life outcome measure that is scored on a visual analog scale from 0 to 100, where a higher score represents better quality of life. Two functional assessments included the American Shoulder and Elbow Society (ASES) Score and the Constant Score. Post-operative recurrent instability and surgical time were also measured. Analyses included ANOVA of repeated measures with Bonferroni adjustments for multiple comparisons, Chi-square and independent t-tests (p < 0.05).Purpose
Method
This prospective, expertise-based randomized clinical trial compares arthroscopic to open shoulder stabilization by measuring the disease-specific quality of life outcome in patients with traumatic unidirectional anterior shoulder instability, and determining the incidence of recurrent instability at 2-years post-operatively. One hundred and ninety-six patients were randomly allocated to arthroscopic (n=98) or open (n=98) repair using an expertise-based approach with a surgeon specializing in one type of surgery. Randomization was performed using computer-generation, variable block sizes and concealed envelopes. Outcomes were measured at baseline, 3 and 6 months, 1 and 2 years post-operatively. These outcomes included the Western Ontario Shoulder Instability (WOSI) Index quality of life outcome and the American Shoulder and Elbow Society (ASES) functional outcome. Both outcomes were measured on a visual analog scale from 0 to 100, where a higher score represents better quality of life or function. Recurrent instability was categorized as traumatic/atraumatic, and as a subluxation/dislocation. Analyses included ANOVA of repeated measures and independent t-tests. Bonferroni adjustments for pairwise contrasts were made for multiple comparisons. Chi-squared analyses were performed on recurrence. Statistical significance was reported at p < 0.05.Purpose
Method
