KinematicTKR Pilot Study KARMA
Research type
Research Study
Full title
Kinetmatic Alignment compaRed to Mechanical Alignment techniques for total knee replacement surgery (KARMA)
IRAS ID
206169
Contact name
Sara Owen
Contact email
Sponsor organisation
RJAH Orthopaedic Hospital
Duration of Study in the UK
2 years, 6 months, 26 days
Research summary
Total knee replacement (TKR) is a bony and soft-tissue procedure and much attention has been given to the alignment of the components, which is relatively easy to quantify. Recently, substantial healthcare resources have been devoted to the development and use of computer navigation and patient-specific instrumentation systems that achieve neutral mechanical alignment. However the conventional assumption that mechanically aligned TKR leads to the best implant survival has been brought into doubt. Although mechanically aligned TKR improves function, 20 % of patients remain dissatisfied according to reports from Canada, England and Wales.
In an attempt to improve patient satisfaction recent developments have included the individualisation of component alignment with the goal of achieving pre- arthritic alignment through restoration of the axes of rotation, a technique called kinematic alignment (KA). The outcomes of kinematic alignment have been assessed in case series but so far only one randomised controlled trial (RCT) [DOI: 10.1302/0301-620X.96B7.32812 Published 1 July 2014] undertaken in the USA has compared the clinical results of kinematic alignment using patient-specific instruments with the traditional technique of mechanical alignment, demonstrating a substantial benefit in postoperative patient pain relief and function.
Therefore, for direct comparison between kinematic aligned and mechanically aligned surgical techniques for total knee replacement, we would like to undertake a pilot study prior to a larger RCT and recruit a cohort of 15 patients undergoing kinematical aligned TKR. We will use the same device as was used in a previous mechanically aligned study undertaken at our hospital (REC ref: 12/NE/0293 Attune, DePuy, Warsaw IN, in 35 patients based on the same eligibility criteria who will act as controls), which will allow the opportunity to estimate the standard deviation in the control arm in preparation for the larger RCT.REC name
West Midlands - Black Country Research Ethics Committee
REC reference
16/WM/0321
Date of REC Opinion
3 Aug 2016
REC opinion
Favourable Opinion