Assessing physical activity levels of patients following HTO.
Research type
Research Study
Full title
Assessing physical activity levels of patients following high tibial osteotomy (HTO) with and without bone grafting.
IRAS ID
242284
Contact name
James Belsey
Contact email
Sponsor organisation
University of Winchester
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 0 months, 1 days
Research summary
Summary of Research
Using accelerometers and questionnaires, patient physical activity levels after high tibial osteotomy with and without bone grafts will be assessed.The accelerometers are small devices that can be taped to the anterior thigh, which count the amount of steps a person takes, as well as the time it takes to take them, and whether a patients is standing, sitting or walking at any given time.
It is normal clinical practice for HTO patients to be given questionnaires that aim to subjectively measure their physical activity levels.
This study will compare the physical activity levels of HTO patients with and without bone grafts by administering questionnaires and accelerometers at the following time points: 1 week pre-surgery, and 1, 4, and 12 weeks post-surgery. At each time point, an accelerometer will be worn for 7 days.
This will be the first study to collect objective data and compare it against the subjective data of the questionnaires to ensure their validity as well as to ascertain differences between "graft" and "no graft" patients.
Based on a power analysis, and after accounting for a dropout rate of 15%, 60 patients (30 per group) will be recruited.
Summary of Results
There are no discernible results to report as this study has been terminated prematurely with less than one-sixth of the required data having been collected. The covid-19 pandemic forced the study to be put on hiatus and there is no longer any capacity or funding available to continue data collection, now that research is allowed to resume within the trust.REC name
East Midlands - Leicester Central Research Ethics Committee
REC reference
18/EM/0174
Date of REC Opinion
20 Jun 2018
REC opinion
Further Information Favourable Opinion