Abstract
Purpose
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.
Method
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).
Results
At 2-years post-operatively, mean WOSI scores were not statistically different between the groups (p=0.61): ETAC = 74 (SD = 24; 95% CI = 64 84); Open ICS = 77 (SD = 20; 95% CI = 68 86). There was no difference between groups for mean ASES scores (p=0.34): ETAC = 81 (SD = 20; 95% CI = 73 90); Open ICS = 87 (SD = 18; 95% CI = 79 95), mean Constant scores (p = 0.35): ETAC = 83 (SD = 7; 95% CI = 80 86); Open ICS = 85 (SD = 11; 95% CI = 80 − 90), and recurrent instability (p = 0.41): ETAC = 2; Open ICS = 4. Mean surgical time was 23 minutes for ETAC and 59 minutes for Open ICS (p = 0.00). Three subjects (1 ETAC, 2 Open ICS) had stiff shoulders; however, no major complications were observed.
Conclusion
Patient outcomes improved from baseline to all follow-up periods. There was no difference between the ETAC and Open ICS groups in quality of life, functional outcomes, and recurrent instability at 2 years post-operatively.
