L-TOKO : Long-Term Outcomes of Knee Osteotomy
Research type
Research Study
Full title
Patient reported outcomes, surgical accuracy and cost utilisation following high tibial osteotomy; a prospective, open label, multi-centre, two-armed, observational study.
IRAS ID
236987
Contact name
Matt Dawson
Contact email
Sponsor organisation
Cumbria Partnership NHS Foundation Trust
Duration of Study in the UK
2 years, 1 months, 28 days
Research summary
This study assesses the long-term effects of realigning the knee joint through an operation called high tibial osteotomy (HTO; effectively changing the angle of the knee joint by rearranging the angle of the lower leg by cutting the bone and introducing a gap, to shift weight from the inside to the outside of the knee joint) to alleviate osteoarthritis pain. Two different medical devices which work in different ways will be compared; one is Tomofix, a fixed plate which holds the gap in place, and one is Opty-Line which only creates the gap after surgery through a gradual extension. There is short-term data on the effectivness of Opty-Line, but not long-term data. This study will collate data at one and two years post-surgery. We will assess what patients think of the device they have been fitted with and how they function in daily life following surgery. Furthermore, we will explore how accurate each device is in achieving a planned knee joint correction and also what the average cost of each operation is. A total of 28 patients (14 Tomofix, and 14 Opty-Line) will be recruited. For our main objective, the change in activities in daily living achieved by patients (before surgery vs 2 years post-surgery; comparison of the two devices) we will ask patients to complete the KOOS questionnaire which is a validated knee outcome specific survey. The results of this study may contribute to informing surgeons and patients what device may be best suited to their needs.
REC name
Wales REC 7
REC reference
18/WA/0025
Date of REC Opinion
6 Mar 2018
REC opinion
Further Information Favourable Opinion