High Tibial Osteotomy With Allograft Wedge Clinical Trial
Official title:
Assessing Physical Activity Levels of Patients Following High Tibial Osteotomy (HTO) With and Without Bone Grafting.
| NCT number | NCT03526172 |
| Other study ID # | UMT057/13 |
| Secondary ID | |
| Status | Suspended |
| Phase | |
| First received | |
| Last updated | |
| Start date | February 26, 2019 |
| Est. completion date | December 2022 |
| Verified date | November 2021 |
| Source | University of Winchester |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
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.
| Status | Suspended |
| Enrollment | 60 |
| Est. completion date | December 2022 |
| Est. primary completion date | December 2022 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | 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 |
| Country | Name | City | State |
|---|---|---|---|
| United Kingdom | University of Winchester | Winchester |
| Lead Sponsor | Collaborator |
|---|---|
| University of Winchester | Hampshire Hospitals NHS Foundation Trust |
United Kingdom,
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| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | |
| Primary | 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 | 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 | |
| Secondary | 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 |