Assessing Physical Activity Levels of Patients Following HTO.

Study Overview
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Brief Summary
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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.

Official Title
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Assessing Physical Activity Levels of Patients Following High Tibial Osteotomy (HTO) With and Without Bone Grafting.

Conditions
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High Tibial Osteotomy With Allograft Wedge, High Tibial Osteotomy Without Allograft Wedge, Pre- and Post-operative Physical Activity Levels

Intervention / Treatment
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* Procedure: High tibial osteotomy
* Device: Allograft wedge
* Device: Accelerometer
* Other: Questionnaire


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Control<br>Patients undergoing HTO without the inclusion of any bone wedge | Procedure: High tibial osteotomy<br>* Uni-lateral medial opening-wedge high tibial osteotomy following a minimally invasive approach.<br>Device: Accelerometer<br>* ActivPal accelerometer attached to thigh of patient to collect objective physical activity data at pre-determined intervals before and after surgery<br>Other: Questionnaire<br>* Validated clinical questionnaires administered to patients to collect subjective physical activity data at pre-determined intervals before and after surgery<br>|
| Allograft<br>Patients undergoing HTO with the inclusion of an allograft bone wedge | Procedure: High tibial osteotomy<br>* Uni-lateral medial opening-wedge high tibial osteotomy following a minimally invasive approach.<br>Device: Allograft wedge<br>* Insertion of allograft wedge into the osteotomy gap during the HTO procedure<br>Device: Accelerometer<br>* ActivPal accelerometer attached to thigh of patient to collect objective physical activity data at pre-determined intervals before and after surgery<br>Other: Questionnaire<br>* Validated clinical questionnaires administered to patients to collect subjective physical activity data at pre-determined intervals before and after surgery<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Objective physical activity levels (measured in steps per day) | 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 | 14 weeks per patient | 
| Intensity of physical activity (measured in steps per minute) | 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 | 14 weeks per patient | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Subjective reasons, thoughts and feelings behind post-operative physical activity levels (thematic analysis) | interviews with fully healed patients to determine their reasons, thoughts and feelings behind their post-operative levels of physical activity | 1 hour per patient | 
| Subjective physical activity levels | Physical activity data (step-count and body position) collected via the implementation of validated questionnaires at pre-determined intervals before and after surgery | 14 weeks per patient |