X-PSI Knee System_v1
Research type
Research Study
Full title
Establish implant accuracy with X-PSI Knee System - A multi-center, prospective, non-controlled post market study
IRAS ID
226693
Contact name
Adrian Harvey
Contact email
Sponsor organisation
Zimmer Biomet
Clinicaltrials.gov Identifier
DRKS, DRKS00011851
Duration of Study in the UK
1 years, 4 months, 31 days
Research summary
Patient-specific instruments (PSI) provide surgeons with an anatomically personalized surgery tool. The newly developed and CE-marked X-PSI Knee System is based on X-rays used to generate a pre-operative 3D model of the knee. The total knee replacement surgery will then be planned according to this 3D model. The main purpose of this study is to evaluate the accuracy of this new PSI system generated by x-rays for total knee arthroplasty (TKA). The X-PSI pin guides are designed to facilitate a more simplified, efficient and customized TKA procedure compared to conventional, non-guided instrumentation.
The aim of this multi-center, prospective, non-controlled post-market study is to scientifically document the accuracy and subsequent clinical performance of the X-PSI Knee System. To evaluate the accuracy of the X-PSI Knee System, early postoperative (4-6 weeks) imaging data will be analysed with regards to the mechanical alignment (hip-knee-ankle angle) of the leg and matched to preoperative planning imaging data. The X-PSI Knee System cohort will then be compared with current literature (70% of cases within ±3 degrees) where patients were conventionally operated with non-guided surgery. No control group will be studied. The study population will be compromised of males and females requiring total knee arthroplasty and satisfy the inclusion/exclusion criteria. The study will last one (1) year from the time of surgery.
The collected data aim to improve the treatment of patients suffering from degenerative joint diseases and their quality of life. In addition, shorter surgery times possibly result in reduced risk of infection, decreased time of anaesthesia and better cost-effectiveness.REC name
East of Scotland Research Ethics Service REC 2
REC reference
17/ES/0148
Date of REC Opinion
19 Dec 2017
REC opinion
Further Information Favourable Opinion