All Polyethlene Vs Metal Backed Tibial Components in Knee Replacement
Research type
Research Study
Full title
All Polyethylene Versus Metal Backed Tibial Components in Knee Replacement – A Comparison Study A Prospective Randomised Control Trial to Compare the clinical and radiological outcomes of the PFC Sigma All-Polyethylene Tibial component Versus Metal Backed Tibial Component Implant Designs, in patients aged 75 years or over
IRAS ID
136376
Contact name
Hazel Everest
Contact email
Sponsor organisation
Maidstone & Tunbridge Wells NHS Trust
Clinicaltrials.gov Identifier
NCT02482493, Clinical Trials.gov Identifier
Duration of Study in the UK
6 years, 7 months, 14 days
Research summary
Total knee arthroplasty (TKA) is one of the most commonly performed orthopaedic procedures. Approximately 84,000 knee replacement procedures were recorded in the UK in 2012. The main goal of TKA is to relieve the disabling pain of arthritic disease.
Patient satisfaction following TKA is related to quick recovery and return to daily activities. This can be dependent on the design of the implant used in the knee. Improvements in implant design and surgical technique mean many modern designs offer implant survival rates beyond 10 - 15 years.
As cost pressure increases in the NHS the unit cost of implants is now being scrutinised, particularly with regard to cost effectiveness. The PFC Sigma implant can be used with either a conventional metal backed or alternatively an all polythethlyne tibial component (part fitted to the shin bone), the latter considerably cheaper to manufacture. Four small prospective randomised trials and one large regional registry study with long follow up support the safe use of all polythene tibial components in TKR. We will therefore undertake a prospective randomised controlled trial comparing the results of all polythene tibial components with those of conventional metal backed tibial components in patients aged 75 or over, comparing both clinical outcome and survivorship.
The type of knee replacement used for each patient (metal-backed or polyethlyne ) will be chosen at random once a patient has agreed to take part in the study.
Data will be collected by means of follow-up appointments and questionnaires and clinical tests both before the operation 1 year, 2 years and 5 years postoperatively. This will allow us to see how both types of knee replacement perform over time and if one performs better than the other in terms of patients movement, pain and functional activities.REC name
London - Bromley Research Ethics Committee
REC reference
15/LO/2110
Date of REC Opinion
18 May 2016
REC opinion
Further Information Favourable Opinion