Document is current

Article History

Received: 30 August 2024

Accepted: 20 November 2024

First Online: 30 November 2024

Declarations

:

: The study will be performed according to the Declaration of Helsinki and the Danish Code of Conduct for Research Integrity. The study has been approved by the Regional Committees on Health Research for Southern Denmark project-ID S-20230058. Further the project has been submitted to and approved by the Region of Southern Denmark and listed in the internal record. Permission from the Institutional Review Board of the Spine Centre of Southern Denmark has been obtained, journal no. 02/2023. Participation in the study is completely voluntary and can only take place after receiving both oral and written information about the study and signing a written consent. Patient information adheres to format requirements from the health research ethics committees and EU legislation. At any time during the study, the participants can withdraw their consent, and this will not affect the right to any current or future treatment. The participants are entitled to bring a member of the family or a friend to the informative interview and will be given several days from study information by phone and written information send by mail to consider participation. The informed consent form will be signed by all participating patients and stored at the Spine Surgery and Research unit, Kolding. A digital copy of the form will be added to the electronic patient records accessible at sundhed.dk.

: A copy of the consent form that patients need to sign for study participation, along with a lay summary of the protocol, can be found on the following website: Permission to extract and publish data from hospital records will be obtained from the patients. Consent to use patient-reported information from the DaneSpine database is obtained electronically prior to patients completing the questionnaires. Patients who do not consent will not be included in the trial. Findings will be disseminated in peer-reviewed publications and presented at national and international conferences following guidance from the SPIRIT guidelines.

: Protocol 101528 version 3.1, date 02.10.23.Recruitment initiated 01.01.2024.Recruitment expected completed 31.12.2028.

: The authors declare no competing interests.