Osteoarthritis Clinical Trial
Official title:
A Prospective Clinical Investigation to Assess Safety and Performance of ARTEBONE as Bone Void Filler in a Single Arthrodesis Procedure of the Ankle (Ankle Joint or Subtalar Joint)
The purpose of this investigation is to assess safety and performance of ARTEBONE Bone Void Filler in the single arthrodesis procedure.
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.
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