High Tibial Osteotomy With Allograft Wedge, High Tibial Osteotomy Without Allograft Wedge, Pre- and Post-operative Physical Activity Levels
Conditions
Brief summary
High tibial osteotomy (HTO is often indicated in physically active patients. The insertion of a bone graft during surgery has been shown to have good clinical and biomechanical outcomes, however objective data regarding post-surgery physical activity (PA) levels in patients who have undergone HTO with and without bone grafts does not exist in the literature. Using accelerometers and questionnaires, this study will be the first to investigate this in an objective way.
Interventions
PROCEDUREHigh tibial osteotomy
Uni-lateral medial opening-wedge high tibial osteotomy following a minimally invasive approach.
DEVICEAllograft wedge
Insertion of allograft wedge into the osteotomy gap during the HTO procedure
DEVICEAccelerometer
ActivPal accelerometer attached to thigh of patient to collect objective physical activity data at pre-determined intervals before and after surgery
OTHERQuestionnaire
Validated clinical questionnaires administered to patients to collect subjective physical activity data at pre-determined intervals before and after surgery
Sponsors
Hampshire Hospitals NHS Foundation Trust
University of Winchester
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patient undergoing unilateral medial opening wedge high tibial osteotomy at Basingstoke & North Hampshire Hospital, UK
Exclusion criteria
* Concurrent procedures during HTO surgery * The use of an off-loader knee brace in the 3 weeks leading up to surgery * Revision surgery
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Objective physical activity levels (measured in steps per day) | 14 weeks per patient | Physical activity data (step-count and body position) collected via an accelermeter that is attached to the thigh for 7 day periods at pre-determined intervals before and after surgery |
| Intensity of physical activity (measured in steps per minute) | 14 weeks per patient | Physical activity data (step-count and body position) collected via an accelermeter that is attached to the thigh for 7 day periods at pre-determined intervals before and after surgery |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Subjective reasons, thoughts and feelings behind post-operative physical activity levels (thematic analysis) | 1 hour per patient | interviews with fully healed patients to determine their reasons, thoughts and feelings behind their post-operative levels of physical activity |
| Subjective physical activity levels | 14 weeks per patient | Physical activity data (step-count and body position) collected via the implementation of validated questionnaires at pre-determined intervals before and after surgery |
Countries
United Kingdom
Outcome results
None listed