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Halting of all research and elective surgeries due to the Covid-19 pandemic
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| Name | Class |
|---|---|
| Hampshire Hospitals NHS Foundation Trust | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | Patients undergoing HTO without the inclusion of any bone wedge |
| |
| Allograft | Patients undergoing HTO with the inclusion of an allograft bone wedge |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| High tibial osteotomy | Procedure | Uni-lateral medial opening-wedge high tibial osteotomy following a minimally invasive approach. |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Prospective HTO patients on a patient database at Basingstoke & North Hampshire Hospital, UK.
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| Name | Affiliation | Role |
|---|---|---|
| Simon Jobson | University of Winchester | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Winchester | Winchester | SO22 4NR | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19299836 | Background | Copeland JL, Esliger DW. Accelerometer assessment of physical activity in active, healthy older adults. J Aging Phys Act. 2009 Jan;17(1):17-30. doi: 10.1123/japa.17.1.17. | |
| 28966555 | Background | 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. |
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No individual participant data will be made available to other researchers. Aggregated and analysed data will be anonymised and included in publications in peer-reviewed journals
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| ID | Term |
|---|---|
| D011795 | Surveys and Questionnaires |
| ID | Term |
|---|---|
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D017531 | Health Care Evaluation Mechanisms |
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| Allograft wedge | Device | Insertion of allograft wedge into the osteotomy gap during the HTO procedure |
|
| Accelerometer | Device | ActivPal accelerometer attached to thigh of patient to collect objective physical activity data at pre-determined intervals before and after surgery |
|
| Questionnaire | Other | Validated clinical questionnaires administered to patients to collect subjective physical activity data at pre-determined intervals before and after surgery |
|
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 |
| 27281368 | Background | 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. |
| 27997276 | Background | 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. |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |