Trident® II 3D - South Tees
Research type
Research Study
Full title
Performance and Function of the Trident® II 3D printed Acetabular Component
IRAS ID
276445
Contact name
Simon Jameson
Contact email
Sponsor organisation
South Tees Hospitals NHS Foundation Trust
ISRCTN Number
ISRCTN57876689
Duration of Study in the UK
12 years, 0 months, 1 days
Research summary
This is a post-market clinical, prospective single centre cohort study of a CE marked device. The hip is a ball and socket joint. In a total hip arthroplasty (THA), both the ball and the socket will be replaced. Trident II is a new component that will be used to replace the socket of the hip, in a THA. Participants in this study will be amongst the first to be receiving the Trident II component as part of their routine care. Therefore, it is important to find out how the hip performs and how well patients are performing after a THA. \n\nPatients meeting the criteria for the study will be asked to enroll, targeting males and non-pregnant females between 40 and 75 years of age, a BMI < 40, requiring uncemented primary THA as a result of osteoarthritis (OA), avascular necrosis (AVN) or post-traumatic arthritis (TA). This new component aims to offer patients a better range of movement, lower the risk of dislocation and a more stable joint.\n \nThe patients will be monitored clinically by follow-up examinations, radiographs and patient reported outcome questionnaires (Oxford Hip Score (OHS), Forgotten Joint Score (FJS), EQ5D-5L). OHS assesses symptoms and functional limitations related to the hip. The FJS is a tool to assess patient’s awareness of their artificial joint in everyday life. EQ5D-5L is a standardised instrument for use as a measure of health outcome and quality of life.\n\nThe length of the study follow-up schedule is not current local standard practice following THA due to constraints related to CCG funding. However, this study will implement a pragmatic, long-term post-operative follow-up based on the BOA standards for introducing new implants as per the study evaluation schedule. While long-term data will be collected, the radiographic requirements for the study will not exceed the national recommendations of the BOA.
REC name
South West - Central Bristol Research Ethics Committee
REC reference
22/SW/0024
Date of REC Opinion
15 Mar 2022
REC opinion
Further Information Favourable Opinion