Abstract
Purpose
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.
Method
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.
Results
There were no statistically significant differences at baseline with respect to gender, involved dominant shoulders, age, WOSI or ASES scores. At 2-years post-operatively, 19 patients in the Open group and 14 patients in the Arthroscopic group were lost to follow-up. A comparison of the baseline characteristics of these lost to follow-up patients showed no statistically significant differences in WOSI and ASES scores, age, involved dominant shoulder, gender and presence of Hill Sachs lesions between the groups. Of the patients that completed 2-year follow-up, there was no difference in mean WOSI score between the two groups: Open = 85 (SD = 20; 95% CI = 81 89), Arthroscopic = 82 (SD = 20; 95% CI = 77 86), p = 0.31. The ASES score for the Open group at 2-years was 91 (SD = 13; 95% CI = 88 94) and 88 (SD = 16; 95% CI = 85 92) for the Arthroscopic group, p = 0.17. Recurrence rates at 2-years were statistically different with 11% in the Open (9/80) and 23% in the Arthroscopic (20/87) groups, p = 0.05.
Conclusion
At 2-years post-operative follow-up, there was no difference in disease-specific quality of life between Open and Arthroscopic repair. Open repair had a significantly lower risk of recurrence.
