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We appreciate the comments on our study from Hong C-K and Su W-R, van Deurzen DFP and van den Bekrom MPJ, and Edwards D and Funk L.
While planning the study, about 10 years ago, we had lengthy discussions about the ethics of what was proposed. We all had reservations about this issue, in particular the shoulder surgeon, but our experience having completed the clinical trial is in agreement with previously published sham surgical studies.1 2 Patients in sham surgical groups have fewer complications than those who undergo repair or any other procedure.3 4 Hong and Su suggest that it was unethical to assign patients to sham surgery because the current literature does not suggest that shaving arthroscopy or arthroscopic irrigation is helpful for these patients.5 We do not understand the reference to ‘shaving arthroscopy procedure’ since this was not used in the present trial. A diagnostic arthroscopy does involve irrigation but, unlike the degenerative knee, where irrigation may give some general pain relief by removing cytokines etc, the patients in the present study did not have degenerative cartilage damages of the glenohumeral joint. Our major concern is that new surgical procedures are introduced and applied in a large number of patients worldwide despite lack of evidence about their effectiveness. Current clinical practice states that it is ethically acceptable to conduct sham surgery to evaluate minor surgical procedures when the informed written and oral consent has been obtained from the patient.3 6 7 In our opinion it is unethical to introduce new surgical procedures into clinical practice before they have been properly evaluated in clinical trials. For example, the ethics of using the most common surgical shoulder procedure are questioned because a clinical trial published decades ago did not demonstrate that acromioplasty was actually superior to …
Competing interests None declared.
Patient consent Obtained.
Ethics approval Ethical Committee Health Region South East of Norway.
Provenance and peer review Not commissioned; internally peer reviewed.
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