Trials / Terminated
TerminatedNCT03526172
Assessing Physical Activity Levels of Patients Following HTO.
Assessing Physical Activity Levels of Patients Following High Tibial Osteotomy (HTO) With and Without Bone Grafting.
- Status
- Terminated
- Phase
- —
- Study type
- Observational
- Enrollment
- 10 (actual)
- Sponsor
- University of Winchester · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
- High Tibial Osteotomy With Allograft Wedge
- High Tibial Osteotomy Without Allograft Wedge
- Pre- and Post-operative Physical Activity Levels
Interventions
| Type | Name | Description |
|---|---|---|
| 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 |
Timeline
- Start date
- 2019-02-26
- Primary completion
- 2020-05-30
- Completion
- 2020-05-30
- First posted
- 2018-05-16
- Last updated
- 2024-10-15
Locations
1 site across 1 country: United Kingdom
Source: ClinicalTrials.gov record NCT03526172. Inclusion in this directory is not an endorsement.