OrthoPure XT Multiligament PMCF Study
Research type
Research Study
Full title
POST MARKET CLINICAL FOLLOW-UP OF ORTHOPURE XT FOR THE TREATMENT OF MULTILIGAMENT INJURED KNEES: A CASE SERIES
IRAS ID
314147
Contact name
Ian Dos Remedios
Contact email
Sponsor organisation
TRX Orthopaedics Ltd
Clinicaltrials.gov Identifier
Duration of Study in the UK
3 years, 0 months, 1 days
Research summary
The OrthoPure XT device is a xenograft tissue scaffold that is intended to be used to treat patients that are suffering with knee ligament injuries to restore their knee function and stability. Knee ligaments are short bands of though, flexible tissue that hold the knee together. Xenograft is tissue or organ made from one species and transplanted into another. The OrthoPure XT device xenograft is made from porcine. The device is approved for use in the EU and UK for ligament reconstruction.
This study is looking to identify any residual risks during multi-ligament knee reconstruction and to continue evaluation of the device safety and performance so no new risk arise during multi-ligament knee reconstruction.
For patients that choose to participate in the study, data will be collected on the device and their knee function from before the knee surgery and up to 2 years after the surgery. Subjects will attend a pre-operative visit before the surgery, intra-operative visit (same day as device implant), and follow-up visits at 1 month, 3 months, 6 months, 1 year and 2 years after the surgery.REC name
South East Scotland REC 02
REC reference
23/SS/0056
Date of REC Opinion
19 Jun 2023
REC opinion
Further Information Favourable Opinion