TRabecular metal Economic and Clinical Knee Trial (TRECK)
Research type
Research Study
Full title
Health Economic and clinical comparison of Trabecular Metal Uncemented and Cemented Modular Total Knee Replacements - A Double Blinded Randomised Controlled Trial
IRAS ID
260273
Contact name
Mark Blyth
Contact email
Sponsor organisation
NHS Greater Glasgow and Clyde
Clinicaltrials.gov Identifier
Duration of Study in the UK
11 years, 11 months, 28 days
Research summary
This study will recruit 144 patients undergoing routine knee replacement surgery at Glasgow Royal Infirmary. The aim of the study is to compare the clinical outcomes and economic burdens of using a standard cemented knee replacement compared to an uncemented knee replacement. The uncemented product that we have chosen to compare utilises Trabecular metal at the bone growth interface. This is a unique product with a highly porus structure that allows new bone in-growth into the implant, potentially providing a better long-term fixation solution than traditional cement (or alternative forms of uncemented implants) which can loosen over time.
The theoretical advantages of uncemented knee replacements include faster surgical times allowing greater theatre utilisation and cost efficiency, reduced risk of fat and bone marrow embolism during surgery, better long term fixation and potentially better clinical outcomes.
Patients will be randomised to receive either a cemented or an uncemented knee replacement. Both knee implants will be identical and the only difference between the two study groups will be the method of implant fixation. Both knee implants are CE marked and are currently marketed throughout Europe. We will undertake a clinical evaluation following both groups for 10 years post-operatively to determine long-term clinical outcomes and safety. We will also undertake a health economic comparison determining the potential cost savings to the NHS for using uncemented knee replacement implants.REC name
South East Scotland REC 02
REC reference
21/SS/0016
Date of REC Opinion
8 Mar 2021
REC opinion
Further Information Favourable Opinion