ClinicalTrials.gov, NCT04669483. Registered 15 December 2020, https://www.clinicaltrials.gov/ct2/show/NCT04669483?term=NCT04669483&draw=2&rank=1
German Clinical Trials Registry, DRKS00022571. Registered 15 December 2020, https://www.drks.de/drks_web/navigate.do?navigationId=trial.HTML&TRIAL_ID=DRKS00022571
Recruitment is expected to start in February 2021 and finish in January 2023.
The project, on which this publication is based, is funded by the Innovation Committee at the German Federal Joint Committee (Gemeinsamer Bundesausschuss; G-BA) under the funding code: 01VSF19025. There are no other sources of financial, material or other support.
Roles and responsibilities
Trial sponsor: Institute for Research in Operative Medicine, Faculty of Health, School of Medicine, Witten/Herdecke University; Ostmerheimer Str. 200, 51109 Cologne, Germany
Project leader: Dr. Tim Mathes, Institute for Research in Operative Medicine, Faculty of Health, School of Medicine, Witten/Herdecke University; Ostmerheimer Str. 200, 51109 Cologne, Germany; e-mail: [email protected].
The study funder has no influence on study design; collection, management, analysis, and interpretation of data; writing of the report or the decision to submit the report for publication.
Concept-development for sub-study I: AS, JLü, SZ, JLa; concept-development for sub-study II: TM, AW, SB, AS, JLü, SZ, JLa, HR, FS, DA, AB; concept-development for sub-study III: TM, AW, SB, DA, AB; concept-development for sub-study IV: AS, JLü, SZ, JLa; Designing the statistical analysis plan: TM; project coordination: TM, AW, SB. All authors participated in writing the manuscript and approved the final version.
Ethics and dissemination
Research ethics approval
We received approval from the ethics committee of the Witten/Herdecke University.
Any changes or modifications to the study protocol can only be authorized by the project leader and will be made transparent as amendments in the study protocol. The ethics committee will be informed of any substantial changes to the study protocol. If necessary, the ethical approval will be updated.
Consent to participate
The request for willingness to participate and information about the study (III) will take place at consultation during office hours in the clinic for orthopedics, trauma surgery and sports traumatology of the Cologne-Merheim hospital. The research staff will inform the patient about rationale, background, objectives, potential risks, expected benefits, data usage and other relevant aspects of the study using a standardized written patient information and verbally. The patient will get sufficient time to resolve open questions and decide about participation. For participation in the study, the patient has to sign a written informed consent form, including agreement on data usage. The participant receives a copy of the written informed consent form. The participant can withdraw consent without any disadvantage.
In this study, we will collect and process personal data and data on treatment and course of disease from participants. Data will be collected and electronically saved by research staff using patient identification numbers as pseudonyms. We will adhere to the ”REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL on the protection of natural persons with regard to the processing of personal data and on the free movement of such data, and repealing Directive 95/46/EC (General Data Protection Regulation)”.
Declaration of interest/Competing interests
The authors declare that they have no competing interests.
Availability of Data and Materials
Anonymised data will be published at Open Science Framework https://osf.io/.
The results will be disseminated through open access publications in international peer-reviewed journals and by presentations at conferences for evidence-based medicine or healthcare research. The results will be published irrespective of whether they are positive or negative. Eligible authors are all individuals who meet the criteria for authorship according to the International Committee of Medical Journal Editors (49). In addition, the final study protocol including all amendments will be made available.
Consent for publication