Liptak, Matthew G.
Theodoulou, Annika
Kaambwa, Billingsley
Saunders, Steve
Hinrichs, Scott W.
Woodman, Richard J.
Krishnan, Jeganath
Funding for this research was provided by:
South Australian Innovation Project Grant (NA)
Article History
Received: 3 October 2018
Accepted: 4 December 2018
First Online: 10 January 2019
Ethics approval and consent to participate
: This study received ethical approval from The Bellberry Human Research Ethics committee (HREC) on 24 September 2018. Study ID: 2016-03-221. Informed consent will be obtained from all study participants.
: Not applicable.
: As the inventor of the Maxm Skate Device and package and Managing Director of Maxm Pty Ltd., MGL presents a conflict of interest to this research. The study has been designed to manage this conflict though blinding of treatment groups and limiting MGL’s role to clinical responsibilities as the treating surgeon. MGL will conduct the screening for eligibility of all patients consented for elective primary total knee arthroplasty; however, he will not be involved in recruitment or collection of data, other than completing the operative data collection form. At completion of this trial, MGL will be involved in data presentation and publication; however, this will be in collaboration with the study investigators, clinical researcher, physiotherapists, health economist and biostatistician. Analysis and interpretation of functional data will be performed by physiotherapist SS with advice from statistician RW; analysis and interpretation of economics evaluations will be performed by economist BK with advice from RW; patient-reported outcome measures will be analysed and interpreted by the clinical researcher KG with advice from RW. Once these analyses are complete, they will be circulated to all investigators for input and overall interpretation as a complete study. It is only at this point that device developer MGL will contribute to interpretation, particularly regarding clinical meaningfulness of the findings. MGL will be involved in presentation and publication of study findings. SS declares that he holds equity in Maxm Pty Ltd. The remaining authors (AT, BK, SWH, RJW and JK) declare that they have no competing interests.
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