Posterolateral or direct lateral approach for cemented hemiarthroplasty after femoral neck fracture (APOLLO): protocol for a multicenter randomized controlled trial with economic evaluation and natural experiment alongside.

"Registration, ethics, data sharing plan, funding, and potential conflicts of interests This trial was registered at clinicaltrials.gov (NCT04438226) prior to the start of inclusion. The study has been approved by the local and the Medical Ethics Committee (METC) (number NL63378.100.17) and will be conducted according to the principles of the Declaration of Helsinki, as amended in Seoul and Fortaleza (64th WMA General Assembly, October 2013) (25) and in accordance with the Medical Research Involving Human Subjects Act (WMO) and other guidelines, regulations, and Acts. In all participating hospitals the study protocol will be submitted for review and approval by the local research ethics board. Any substantial amendments will be notified to the accredited Medical Ethical Committee. The investigator will report all SAEs related to the treatment to the sponsor and report the SAEs through the web portal ToetsingOnline to the accredited METC that approved the protocol, within 7 days of first knowledge for SAEs that result in death or are life threatening. All other SAEs will be reported within a maximum period of 15 days after the sponsor has first knowledge of the serious adverse events. Data will be managed and archived for 15 years at the initiating hospital (OLVG). We intend to facilitate data sharing in line with the FAIR (Findability, Accessibility, Interoperability, and Reuse) principles, taking into account European laws and guidelines for privacy, and upon reasonable request. All included patients receive a trial code, which pseudonymizes their personal data. The link between the trial code and the patient’s personal data is saved in a separate secured file with access only by the coordinating investigator (MCJMT) and research assistant (AR). The outcome data is only accessible for the coordinating investigator (MCJMT), principal investigator (RWP), research assistant (AR), supervisor (NWW), and authorized research personnel of the Joint Research team in OLVG Amsterdam. The handling of personal data will comply with the Dutch Personal Data Protection Act. The results from the study will be submitted for publication in peer-reviewed journals and presented at international conferences. This trial is supported by the Dutch Organisation for Health Research and Development (ZonMw grant number: 8430041 12). There are no conflicts of interests for all authors."

"This trial was registered at clinicaltrials.gov (NCT04438226) prior to the start of inclusion."