Pheno4U - Nottingham University Hospitals, Version 1.0
Research type
Research Study
Full title
Prospective, multinational pilot study to evaluate the functionality of the Pheno4U data platform to identify individual patient risks in knee arthroplasty by linking data from multiple sources along the treatment pathway.
IRAS ID
321116
Contact name
Khosrow Sehat
Contact email
Sponsor organisation
Aesculap AG
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 10 months, 31 days
Research summary
The study is designed as a prospective, non-interventional, multinational study. It will be conducted at six sites (in Germany, France and the United Kingdom) collecting data of 600 patients.
The products under investigation will be used in routine clinical practice and according to the Instructions for Use (IFU, see Appendix 4). Data obtained in routine clinical use will be collected in the Pheno4U data platform.
In addition, patients are expected to answer questionnaires about their health status. Furthermore, patients are asked to use the BPMpathway sensor and application in order to measure the active ROM. The sensor can also be used for pre- and postoperative training.
This clinical study is called a pilot study because it is intended to evaluate the functionalities of the Pheno4U data platform for the first time with real patient data in clinical use by physicians. This serves to support the technical assumptions of the software and dashboard to further develop the application to market maturity. Therefore the study does not have any primary endpoint as the potential of the data collected in this pilot study can only be analysed when the data collection is finished. It is planned to conduct a following study once the pilot phase has been completed.REC name
North West - Greater Manchester South Research Ethics Committee
REC reference
23/NW/0135
Date of REC Opinion
22 Jun 2023
REC opinion
Further Information Favourable Opinion