Assessing Physical Activity Levels of Patients Following HTO.
Study Details
Study Description
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.
Condition or Disease | Intervention/Treatment | Phase |
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Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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Control Patients undergoing HTO without the inclusion of any bone wedge |
Procedure: High tibial osteotomy
Uni-lateral medial opening-wedge high tibial osteotomy following a minimally invasive approach.
Device: Accelerometer
ActivPal accelerometer attached to thigh of patient to collect objective physical activity data at pre-determined intervals before and after surgery
Other: Questionnaire
Validated clinical questionnaires administered to patients to collect subjective physical activity data at pre-determined intervals before and after surgery
|
Allograft Patients undergoing HTO with the inclusion of an allograft bone wedge |
Procedure: High tibial osteotomy
Uni-lateral medial opening-wedge high tibial osteotomy following a minimally invasive approach.
Device: Allograft wedge
Insertion of allograft wedge into the osteotomy gap during the HTO procedure
Device: Accelerometer
ActivPal accelerometer attached to thigh of patient to collect objective physical activity data at pre-determined intervals before and after surgery
Other: Questionnaire
Validated clinical questionnaires administered to patients to collect subjective physical activity data at pre-determined intervals before and after surgery
|
Outcome Measures
Primary Outcome Measures
- 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 Outcome Measures
- 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
Eligibility Criteria
Criteria
Inclusion Criteria:
- Patient undergoing unilateral medial opening wedge high tibial osteotomy at Basingstoke & North Hampshire Hospital, UK
Exclusion Criteria:
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Concurrent procedures during HTO surgery
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The use of an off-loader knee brace in the 3 weeks leading up to surgery
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Revision surgery
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
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1 | University of Winchester | Winchester | United Kingdom | SO22 4NR |
Sponsors and Collaborators
- University of Winchester
- Hampshire Hospitals NHS Foundation Trust
Investigators
- Study Director: Simon Jobson, University of Winchester
Study Documents (Full-Text)
None provided.More Information
Publications
- Copeland JL, Esliger DW. Accelerometer assessment of physical activity in active, healthy older adults. J Aging Phys Act. 2009 Jan;17(1):17-30.
- Eisenberg MH, Phillips LA, Fowler L, Moore PJ. The Impact of E-diaries and Accelerometers on Young Adults' Perceived and Objectively Assessed Physical Activity. Psychol Sport Exerc. 2017 May;30:55-63. doi: 10.1016/j.psychsport.2017.01.008. Epub 2017 Jan 31.
- Falck RS, Landry GJ, Brazendale K, Liu-Ambrose T. Measuring Physical Activity in Older Adults Using MotionWatch 8 Actigraphy: How Many Days are Needed? J Aging Phys Act. 2017 Jan;25(1):51-57. doi: 10.1123/japa.2015-0256. Epub 2016 Aug 24.
- Martins RC, Reichert FF, Bielemann RM, Hallal PC. One-year Stability of Objectively Measured Physical Activity in Young Brazilian Adults. J Phys Act Health. 2017 Mar;14(3):208-212. doi: 10.1123/jpah.2015-0384. Epub 2016 Dec 20.
- UMT057/13