Assessing Physical Activity Levels of Patients Following HTO.

November 4, 2021 updated by: University of Winchester

Assessing Physical Activity Levels of Patients Following High Tibial Osteotomy (HTO) With and Without Bone Grafting.

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.

Study Overview

Status

Suspended

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

60

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • Winchester, United Kingdom, SO22 4NR
        • University of Winchester

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Prospective HTO patients on a patient database at Basingstoke & North Hampshire Hospital, UK.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
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: 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
Device: Allograft wedge
Insertion of allograft wedge into the osteotomy gap during the HTO procedure

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Objective physical activity levels (measured in steps per day)
Time Frame: 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
14 weeks per patient
Intensity of physical activity (measured in steps per minute)
Time Frame: 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
14 weeks per patient

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Subjective reasons, thoughts and feelings behind post-operative physical activity levels (thematic analysis)
Time Frame: 1 hour per patient
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
Time Frame: 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
14 weeks per patient

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Winchester

Collaborators

Hampshire Hospitals NHS Foundation Trust

Investigators

  • Study Director: Simon Jobson, University of Winchester

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 26, 2019

Primary Completion (Anticipated)

December 1, 2022

Study Completion (Anticipated)

December 1, 2022

Study Registration Dates

First Submitted

April 21, 2018

First Submitted That Met QC Criteria

May 3, 2018

First Posted (Actual)

May 16, 2018

Study Record Updates

Last Update Posted (Actual)

November 9, 2021

Last Update Submitted That Met QC Criteria

November 4, 2021

Last Verified

November 1, 2021

More Information

Terms related to this study

Other Study ID Numbers

  • UMT057/13

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

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

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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