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Electrothermal arthroscopic capsulorrhaphy : old technology , new evidence . A multicenter randomized clinical trial . BACKGROUND Radiofrequency technology for shoulder instability was rapidly adopted despite limited clinical evidence and a poor understanding of its indications . Reports of serious adverse events followed , leading to its abandonment . This paper presents findings from a multicenter randomized clinical trial evaluating the safety and efficacy of electrothermal arthroscopic capsulorrhaphy ( ETAC ) compared with open inferior capsular shift ( ICS ) and reviews the role of randomized trials in adopting new technology . METHODS Patients ( > 14 years ) diagnosed with multidirectional instability or multidirectional laxity with anteroinferior instability and failed nonoperative treatment were enrolled . Patients with bone lesions or labral , biceps anchor , or full-thickness rotator cuff tears were excluded intraoperatively . Outcomes included Western Ontario Shoulder Instability Index , function and recurrent instability at 2 years postoperatively , and surgical times . RESULTS Fifty-four subjects ( mean age , 23 years ; 37 women ) were randomized to ETAC ( n = 28 ) or open ICS ( n = 26 ) . The groups were comparable at baseline , except for external rotation at the side . At 2 years postoperatively , there were no statistically or clinically significant differences between groups for the Western Ontario Shoulder Instability Index ( P = .71 ) , American Shoulder and Elbow Surgeons score ( P = .43 ) , Constant score ( P = .43 ) , and active range of motion . Recurrent instability was not statistically different ( ETAC , 2 ; open , 4 ; P = .41 ) . ETAC ( 23 minutes ) was significantly shorter than open ICS ( 59 minutes ) ( P < .01 ) surgery . Three subjects ( 1 ETAC , 2 open ) had stiff shoulders . CONCLUSIONS At 2 years postoperatively , quality of life and functional outcomes between groups were not clinically different . ETAC had fewer complications and episodes of recurrence compared with open surgery . This evidence reinforces the need to critically evaluate new technology before widespread clinical use .
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Intervention_Physical
Electrothermal arthroscopic capsulorrhaphy
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Intervention_Physical
electrothermal arthroscopic capsulorrhaphy ( ETAC )
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Intervention_Physical
open inferior capsular shift ( ICS )
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Outcome_Physical
Western Ontario Shoulder Instability Index
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Outcome_Physical
function and recurrent instability at 2 years postoperatively
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Outcome_Other
surgical times
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Outcome_Physical
external rotation at the
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Outcome_Physical
Western Ontario Shoulder Instability
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Outcome_Physical
American Shoulder and Elbow Surgeons
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Outcome_Physical
active range of motion . Recurrent
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Participant_Condition
shoulder instability
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Participant_Age
Patients ( > 14 years )
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Participant_Condition
multidirectional instability
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Participant_Condition
multidirectional laxity with anteroinferior instability and failed nonoperative treatment
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Participant_Sample-size
Fifty-four
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Participant_Age
mean age , 23 years
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Participant_Sex
women
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Participant_Sample-size
n = 26