Assessing Physical Activity Levels of Patients Following HTO.

Sponsor
University of Winchester (Other)
Overall Status
Suspended
CT.gov ID
NCT03526172
Collaborator
Hampshire Hospitals NHS Foundation Trust (Other)
60
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45.1
1.3

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
  • Procedure: High tibial osteotomy
  • Device: Allograft wedge
  • Device: Accelerometer
  • Other: Questionnaire

Study Design

Study Type:
Observational
Anticipated Enrollment :
60 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Assessing Physical Activity Levels of Patients Following High Tibial Osteotomy (HTO) With and Without Bone Grafting.
Actual Study Start Date :
Feb 26, 2019
Anticipated Primary Completion Date :
Dec 1, 2022
Anticipated Study Completion Date :
Dec 1, 2022

Arms and Interventions

Arm Intervention/Treatment
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

  1. 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

  2. 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

  1. 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

  2. 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

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
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

Responsible Party:
University of Winchester
ClinicalTrials.gov Identifier:
NCT03526172
Other Study ID Numbers:
  • UMT057/13
First Posted:
May 16, 2018
Last Update Posted:
Nov 9, 2021
Last Verified:
Nov 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Nov 9, 2021