Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 5:53 PM
Ignite Modification Date:
2025-12-24 @ 5:53 PM
NCT ID:
NCT02480868
Brief Summary:
The purpose of this investigation is to assess safety and performance of ARTEBONE Bone Void Filler in the single arthrodesis procedure.
Detailed Description:
This is a multi-centre, prospective clinical investigation in subjects in need of a single arthrodesis procedure of the ankle (ankle joint or subtalar joint) to relieve persistent pain due to primary or secondary osteoarthritis.
The objectives of the study are to assess safety and performance of ARTEBONE as Bone Void Filler in the single arthrodesis procedure of the ankle (ankle joint or subtalar joint).
The study will be monitored regularly by Clinical Research Associates (CRAs). Monitoring procedures include one or more visits designed to clarify all prerequisites before the study commences. Interim monitoring visits will take place on a regular basis according to a schedule fixed by mutual agreement. During these visits, the CRA will check for completion of the entries on the Case Report Forms (CRFs), their compliance with the Clinical Investigation Plan (CIP), the standard operating procedures (SOP), Good Clinical Practice and International Organization for Standardization 14155 (ISO 14155), and will compare the CRF entries with the source data, as well as update the Investigator´s File (IF).
Source data verification will be performed in an unassisted way (direct access to source documents), unless otherwise required by the local ethics committee.
The sample size of 30 subjects was considered adequate for the safety and performance evaluation in this indication based on earlier discussions with the authorities.
An interim analyses will be performed for 6 months data. There will be descriptive analysis only and comparison to literature. Literature search has been done according to European Union (EU) guidelines.
Study:
NCT02480868
Study Brief:
Protocol Section:
NCT02480868