How to investigate “novel techniques”?

I liked the study by Lapner et al. very much. Their study was titled “Preoperative bone marrow stimulation does not improve functional outcomes in arthroscopic cuff repair: a prospective randomized controlled trial”.

They proposed a new concept to improve healing of rotator cuff repair. Authors hypothesized that preoperative ultrasound-guided bone channeling in the footprint 5-7 days prior to the cuff repair would improve the healing process. It’s a theory with reasonable bioplausibility. Traditional method to assess the efficacy of such novel concepts would be an uncontrolled cohort study, observe some regression to mean and natural course of the disease and state that “novel technique A is useful in the treatment of X”.

Lapner et al. did not take that road but instead they performed sham-controlled RCT. They could not detect any benefit from this procedure and fairly conclude:

Preoperative bone channelling one week prior to arthroscopic rotator cuff repair was not associated with significant improvements in WORC, ASES, Constant scores, strength, or ultrasound-determined healing rates.

Only this approach was used more often in the orthopaedics.

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