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Gait, Pain and Physical Activity After HTO

Primary Purpose

Osteoarthritis, Knee, Orthopedic Disorder

Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
High tibial osteotomy
Sponsored by
University of Winchester
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Osteoarthritis, Knee

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Experimental group:

Previously undergone unilateral medial opening wedge high tibial osteotomy with no simultaneous procedures (other than arthroscopy), performed by one of 3 different surgeons

Plate since removed

No conversion to arthroplasty since the osteotomy

  • Control group:

Age-matched to experimental group

Never previously undergone any form of lower limb surgery

Exclusion Criteria:

  • Experimental group:

Undergone other procedures simultaneous to the osteotomy

Plate in-situ

  • Control group:

Previously undergone lower limb surgery

Sites / Locations

  • University of Winchester

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Exercise intensity

Arm Description

Jogging or walking at RPE 9, 11, 13, and 15

Outcomes

Primary Outcome Measures

Spatiotemporal parameters of gait
Steps, cadence, speed (etc) measured using G-Walk wireless inertial sensor
Self-reported pain questionnaire
Visual analogues scale (0-10, where 0 = no pain and 10 = the worst imaginable pain)

Secondary Outcome Measures

Self-reported knee function questionnaire
Knee Osteoarthritis Outcome Score validated questionnaire (score /100, where higher number = better knee function)

Full Information

First Posted
October 16, 2020
Last Updated
November 2, 2020
Sponsor
University of Winchester
Collaborators
RTI Surgical Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT04619550
Brief Title
Gait, Pain and Physical Activity After HTO
Official Title
Gait and Residual Pain at Different Physical Activity Intensities in High Tibial Osteotomy Patients and Healthy Controls
Study Type
Interventional

2. Study Status

Record Verification Date
November 2020
Overall Recruitment Status
Completed
Study Start Date
April 15, 2019 (Actual)
Primary Completion Date
November 1, 2019 (Actual)
Study Completion Date
December 31, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Winchester
Collaborators
RTI Surgical Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
This study aims to investigate the relationship between pain, gait and activity intensity in HTO patients that are healed and have had their fixation plate removed. Inclusion criteria are: unilateral HTO with no concurrent procedure performed, fixation plate has since been removed, no subsequent operations performed on the lower limbs (hips to feet). Control participants will be recruited through local advertisements in and around the University of Winchester. Inclusion criteria for the control subjects are: no current pain in the lower limbs, no previous surgery on the lower limbs. Control subjects will also be age-matched to the HTO group. Knee function and pain scores will first be assessed through the implementation of a Knee Osteoarthritis Outcome Score, a Visual Analogue Scale, and a further pain intensity scale. Once this has been done, resting heart rate (HR) and body mass index (BMI) will also be measured as part of the completion of a Physical Activity Readiness Questionnaire (PAR-Q). A G-Walk gait analysis sensor, which has been validated for use in clinical settings, will then be attached to participants in order to measure spatiotemporal gait parameters during testing. Each participant will then conduct a series of four walking and four jogging test protocols, each lasting three minutes, on a flat treadmill. The intensity at which the participant must walk or jog during each test will be self-regulated and determined by a rating of perceived exertion (RPE) of 9, 11, 13 or 15 on a 6-20 Borg scale. All participants will be verbally anchored to the Borg scale before conducting the first walk/jog test. The order in which the tests are performed will be randomised in advance of each test session. Half way through each test (90 seconds), participants will be presented with a VAS and pain intensity scale to indicate the current level of pain they are experiencing in their knee. At this stage, they will also be asked to confirm that they are still maintaining the target RPE of that particular test. Once a test is finished, participants will complete another VAS and pain intensity scale and rest in a seated position until their heart rate returns to their pre-determined resting level before the next test commences. The leg for which healthy controls report pain levels will be chosen randomly prior to the test session.
Detailed Description
This study aims to investigate the relationship between pain, gait and activity intensity in HTO patients that are healed and have had their fixation plate removed. Inclusion criteria are: unilateral HTO with no concurrent procedure performed, fixation plate has since been removed, no subsequent operations performed on the lower limbs (hips to feet). Control participants will be recruited through local advertisements in and around the University of Winchester. Inclusion criteria for the control subjects are: no current pain in the lower limbs, no previous surgery on the lower limbs. Control subjects will also be age-matched to the HTO group. Knee function and pain scores will first be assessed through the implementation of a Knee Osteoarthritis Outcome Score, a Visual Analogue Scale, and a further pain intensity scale. Once this has been done, resting heart rate (HR) and body mass index (BMI) will also be measured as part of the completion of a Physical Activity Readiness Questionnaire (PAR-Q). A G-Walk gait analysis sensor, which has been validated for use in clinical settings, will then be attached to participants in order to measure spatiotemporal gait parameters during testing. Each participant will then conduct a series of four walking and four jogging test protocols, each lasting three minutes, on a flat treadmill. The intensity at which the participant must walk or jog during each test will be self-regulated and determined by a rating of perceived exertion (RPE) of 9, 11, 13 or 15 on a 6-20 Borg scale. All participants will be verbally anchored to the Borg scale before conducting the first walk/jog test. The order in which the tests are performed will be randomised in advance of each test session. Half way through each test (90 seconds), participants will be presented with a VAS and pain intensity scale to indicate the current level of pain they are experiencing in their knee. At this stage, they will also be asked to confirm that they are still maintaining the target RPE of that particular test. Once a test is finished, participants will complete another VAS and pain intensity scale and rest in a seated position until their heart rate returns to their pre-determined resting level before the next test commences. The leg for which healthy controls report pain levels will be chosen randomly prior to the test session.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis, Knee, Orthopedic Disorder

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
23 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Exercise intensity
Arm Type
Other
Arm Description
Jogging or walking at RPE 9, 11, 13, and 15
Intervention Type
Other
Intervention Name(s)
High tibial osteotomy
Intervention Description
Realignment surgery
Primary Outcome Measure Information:
Title
Spatiotemporal parameters of gait
Description
Steps, cadence, speed (etc) measured using G-Walk wireless inertial sensor
Time Frame
9 months recruitment - 2 hours data collection per participant
Title
Self-reported pain questionnaire
Description
Visual analogues scale (0-10, where 0 = no pain and 10 = the worst imaginable pain)
Time Frame
9 months recruitment - 2 hours data collection per participant
Secondary Outcome Measure Information:
Title
Self-reported knee function questionnaire
Description
Knee Osteoarthritis Outcome Score validated questionnaire (score /100, where higher number = better knee function)
Time Frame
9 months recruitment - 2 hours data collection per participant

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Experimental group: Previously undergone unilateral medial opening wedge high tibial osteotomy with no simultaneous procedures (other than arthroscopy), performed by one of 3 different surgeons Plate since removed No conversion to arthroplasty since the osteotomy Control group: Age-matched to experimental group Never previously undergone any form of lower limb surgery Exclusion Criteria: Experimental group: Undergone other procedures simultaneous to the osteotomy Plate in-situ Control group: Previously undergone lower limb surgery
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
James Belsey, MA
Organizational Affiliation
University of Winchester
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Winchester
City
Winchester
ZIP/Postal Code
SO22 4NR
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
No

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Gait, Pain and Physical Activity After HTO

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