CrNAg MRK Pilot Study
Research type
Research Study
Full title
Chromium nitride silver (CrNAg) coated MRK Spacer device Pilot Study
IRAS ID
242314
Contact name
Laura Richards
Contact email
Sponsor organisation
MatOrtho Limited
Eudract number
2018-000277-69
Duration of Study in the UK
1 years, 1 months, 5 days
Research summary
Infection in Total Knee Replacement (TKR) can be treated in two stages. In the first operation the infected TKR components are removed and a temporary Spacer device in implanted to fill the void. During the second stage operation the temporary Spacer Device is removed and this is routinely after 6-8 weeks (depending on a number of factors including the patients’ health and ability to undergo another operation). Off-the-shelf Spacer Devices rarely consider the functionality of a TKR and offer little stability during the interim spacer phase. Therefore surgeons do use primary TKR components as Spacer devices since the stability they offer and the relative movements they allow the patient to make (albeit limited in this phase) reduces risk of arthrofibrosis, dislocation and may improve outcomes for the secondary TKR. This project investigates a chromium nitride silver (CrNAg) coating which is applied via physical vapour deposition, a process commonly used in orthopaedics, to an existing CE marked TKR femoral component (with 17 years clinical use) and with use as a Spacer Device under this study. Introducing new coatings on Spacer Devices gives the unique opportunity to explant the device after a relatively short period of time (maximum 6 months in vivo) allowing for assessment on the operating table and tissue/joint fluid sampling to assess safety end-points at a much reduced risk to the patient as compared to using new coatings on primary implants.
REC name
West Midlands - Edgbaston Research Ethics Committee
REC reference
18/WM/0078
Date of REC Opinion
24 May 2018
REC opinion
Further Information Favourable Opinion