A Comparison of Two Surgical Techniques Using the Unity Knee™
Research type
Research Study
Full title
A prospective randomized double blind single centre study comparing measured resection and ligament balancing implantation techniques using the Unity Knee™ Total Knee System
IRAS ID
238016
Contact name
Mark Forster
Contact email
Sponsor organisation
Corin Ltd
Duration of Study in the UK
3 years, 8 months, 30 days
Research summary
Total knee replacement (TKR) is a very successful operation with over 100,000 procedures carried out in the UK in 2016. However, patient satisfaction is only 80–85% due to ongoing pain and failure to restore knee function. Knee instability is one of the most common problems, often requiring additional treatment or replacement of the implant.\n\nFor TKR to work well components must be well-aligned and ligaments and other soft tissues surrounding the knee must provide continued stability – changes in the knee’s natural orientation are associated with poorer outcomes. There are two commonly used TKR tissue-balancing techniques: measured resection and ligament balancing. Measured resection relies on bony landmarks to determine where bone cuts are made and ligament tension is adjusted after the device is implanted. In ligament balancing, tension is applied to the knee joint and ligaments are equally tensioned before final bone cuts are made. There is no general agreement about which philosophy produces better results. Using both tissue-balancing techniques, the instruments of the Unity Knee™ Total Knee System aim to restore the medial joint line in flexion and extension whilst ensuring good alignment and tissue balancing. No work has been published to compare radiographic and patient-reported outcomes after TKR using the Unity Knee™ with each technique; this research aims to address this question.\n\nPatients listed for TKR and suitable for the Unity Knee™ will be recruited from the hospital’s orthopaedic department and randomised in theatre to one of the surgical techniques. Participants will be seen in clinic for pre-surgery assessment and followed up for 2 years after surgery, with clinic visits at 6 weeks and 6 months post-surgery. A set of X-rays will be taken pre-surgery and 6 weeks post-surgery to evaluate radiographic outcomes. Participants will also complete questionnaires before surgery and up to 2 years afterwards.
REC name
Wales REC 3
REC reference
18/WA/0181
Date of REC Opinion
14 May 2018
REC opinion
Unfavourable Opinion