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Correspondence
Author response—sham surgery versus labral repair or biceps tenodesis for type II SLAP lesions of the shoulder: a three-armed randomised clinical trial
  1. Jens Ivar Brox1,2,
  2. Cecilie Piene Schrøder3,
  3. Øystein Skare3,
  4. Petter Mowinckel4,
  5. Olav Reikerås2,5
  1. 1 Department of Physical Medicine and Rehabilitation, Oslo University Hospital, Oslo, Norway
  2. 2 Medical Faculty, University in Oslo, Oslo, Norway
  3. 3 Department of Orthopedics, Lovisenberg Diakonale Hospital, Oslo, Norway
  4. 4 Department of Pediatrics, Oslo University Hospital, Oslo, Norway
  5. 5 Department of Orthopedics, Oslo University Hospital, Oslo, Norway
  1. Correspondence to Profosser Jens Ivar Brox, Department of Physical Medicine and Rehabilitation, Oslo University Hospital, Oslo, Norway; j.i.brox{at}medisin.uio.no

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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.

Letter 1

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 …

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