CR23-001 Comparative Vantage Infinity RCT
Research type
Research Study
Full title
A single centre Pragmatic RCT comparing Mobile bearing TAR ( Vantage, Exactech) with a fixed bearing TAR ( Infinity, Stryker).
IRAS ID
334450
Contact name
Narasimha Murty Aradhyula
Contact email
Sponsor organisation
Exactech Inc
Duration of Study in the UK
3 years, 0 months, 0 days
Research summary
Total Ankle replacement (TAR) is commonly used when non-operative options have failed.
There are two main types of TAR , fixed bearing (FB) and mobile bearing (MB) .
In both the FB TAR and MB TAR the bottom of the leg bone (Tibia) and the top of the ankle bone (Talus) are replaced by metallic components. In between the two is a third component which is made of very high density polyethylene.
In the FB TAR the polyethylene component is fixed to the tibial component. In the MB TAR the polyethylene slots in between the Tibial and Talar components and is free to move. As this is free to move, the movement achieved after surgery is expected to be better.
The two most commonly implanted systems in the UK are the Infinity FB TAR and Vantage MB TAR. There is a strong debate among surgeons as to which performs better in the short and long term.
The purpose of this study is to compare the outcomes of the Vantage MB TAR to the Infinity FB TAR.
The patients being offered TAR surgery and fulfilling inclusion criteria for the study will be invited to participate. Following informed consent, enrolled patient will be randomly allocated to receive either a Vantage or an Infinity prosthesis.
In these patients, outcome scores and range of motion at the ankle will be measured using validated techniques pre-operatively and post operatively (6-months and 1-year). The improvement in the scores and movement will be the basis for analysis of the results.
REC name
Yorkshire & The Humber - Sheffield Research Ethics Committee
REC reference
24/YH/0134
Date of REC Opinion
20 Aug 2024
REC opinion
Further Information Favourable Opinion