A multicentre single-blind randomised controlled trial of a mobile bearing total knee prosthesis against a fixed bearing prosthesis
Ed Juszczak with Andrew Price (Oxford) and multicentre collaborators (UK & international)
As part of a step-wise validation of a new mobile bearing total knee prosthesis, it is important to establish that its early clinical results are at least as good as those of an established fixed bearing device (the current gold standard) before proceeding to longer term studies.
Patients eligible for this trial were those requiring bilateral knee replacement who consented to have both their operations under one anaesthetic using both types of prosthesis. They also agreed to accept a random choice of knee for the new implant and to remain ignorant as to which side received which implant. American Knee Society Scores (AKSS), Oxford Knee Scores (OKS), range of motion and pain scores were recorded preoperatively and at one- year follow-up.
The investigators believe this to be the first controlled, blinded trial to have compared the function of a new knee prosthesis with that of a standard implant. The study demonstrates that comparison of two implants in the same patient is a powerful design that reduces the number of participants exposed to potential harm compared to a classical parallel group trial.
Publication: 74
