Received: 19 March 2020
Accepted: 19 June 2020
First Online: 6 August 2020
Ethics approval and consent to participate
: Our protocol was approved by the National Joint Registry Research Sub-committee. NHS Health Research Authority advise that secondary uses of anonymised data for audit, research and quality improvement do not require approval by a research ethics committee. With support under Section 251 of the NHS Act 2006, the Ethics and Confidentiality Committee (ECC), (now the Health Research Authority Confidentiality Advisory Group) allows the NJR to collect patient data where consent is indicated as ‘Not Recorded’.
: Before Personal Data and Sensitive Personal Data is recorded, express written patient consent is provided. The NJR records patient consent as either ‘Yes’, ‘No’ or ‘Not Recorded’.
: AWB is a principal investigator on a grant funded by Stryker investigating the outcome of a total knee replacement manufactured by Stryker. GSM has received financial support for other research work from Arthritis Research UK, The Orthopaedics Trust, The Royal College of Surgeons of England and The Royal Orthopaedic Hospital Hip Research and Education Charitable Fund. GSM has also received personal fees for undertaking medicolegal work for Leigh Day. MRR has received grant funding or lecture fees from the Health Foundation, Stryker, Zimmer Biomet, Heraeus Medical, 3M healthcare, Vifor Pharma and Schuelke. MRW is a co-applicant on a grant funded by Stryker investigating the outcome of a total knee replacement manufactured by Stryker.