Assessing Physical Activity Levels of Patients Following HTO.

Terminated

• Conditions: High Tibial Osteotomy With Allograft Wedge; Pre- and Post-operative Physical Activity Levels; High Tibial Osteotomy Without Allograft Wedge
• Interventions: Procedure: High tibial osteotomy; Device: Allograft wedge; Device: Accelerometer; Other: Questionnaire

• Registration Number: NCT03526172
• Lead Sponsor: University of Winchester

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-04-21
• Study First Submitted QC: 2018-05-03
• Study First Posted: 2018-05-16
• Study Start: 2019-02-26
• Primary Completion: 2020-05-30
• Study Completion: 2020-05-30
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-13
• Last Update Posted: 2024-10-15

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 10

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Control	High tibial osteotomy	Patients undergoing HTO without the inclusion of any bone wedge
Allograft	Accelerometer	Patients undergoing HTO with the inclusion of an allograft bone wedge
Allograft	Allograft wedge	Patients undergoing HTO with the inclusion of an allograft bone wedge
Control	Questionnaire	Patients undergoing HTO without the inclusion of any bone wedge
Allograft	High tibial osteotomy	Patients undergoing HTO with the inclusion of an allograft bone wedge
Control	Accelerometer	Patients undergoing HTO without the inclusion of any bone wedge
Allograft	Questionnaire	Patients undergoing HTO with the inclusion of an allograft bone wedge

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

University of Winchester; 🇬🇧 Winchester, United Kingdom