Osteoarthritis, KneeNCT04619550
Gait, Pain and Physical Activity After HTO
A study testing High tibial osteotomy in people with Osteoarthritis, Knee and Orthopedic Disorder, run by University of Winchester at 1 site in United Kingdom.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Osteoarthritis, Knee, Orthopedic Disorder
- What is being tested?
- High tibial osteotomy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 15 Apr 2019to 31 Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Experimental group:
- Undergone other procedures simultaneous to the osteotomy
- Plate in-situ
- Control group:
- Previously undergone lower limb surgery
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Gait and Residual Pain at Different Physical Activity Intensities in High Tibial Osteotomy Patients and Healthy Controls
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.
Read more
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.
Read the 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.
- Conditions
- Osteoarthritis, Knee, Orthopedic Disorder
- Being tested
- High tibial osteotomy
- Medical subject headings
- Osteoarthritis, Knee, Musculoskeletal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High tibial osteotomyOther
Realignment surgery
| Study group | Role | What they receive |
|---|---|---|
| Exercise intensity | Other | Jogging or walking at RPE 9, 11, 13, and 15 Receives: Other: High tibial osteotomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Spatiotemporal parameters of gait
Steps, cadence, speed (etc) measured using G-Walk wireless inertial sensor
Measured: 9 months recruitment - 2 hours data collection per participant
Self-reported pain questionnaire
Visual analogues scale (0-10, where 0 = no pain and 10 = the worst imaginable pain)
Measured: 9 months recruitment - 2 hours data collection per participant
Secondary outcomes (1)
Self-reported knee function questionnaire
Knee Osteoarthritis Outcome Score validated questionnaire (score /100, where higher number = better knee function)
Measured: 9 months recruitment - 2 hours data collection per participant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2020
- Study start15 Apr 2019
- Primary completion1 Nov 2019
- Study completion31 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoarthritis, KneeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Winchester
- Sponsor type
- University, hospital or other
- Collaborators
- RTI Surgical Inc.
- Responsible party
- Sponsor
- Investigators
- James Belsey, MA, Principal investigator, University of Winchester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04619550
- Sponsor's protocol ID
- BLS/19/07
- Status last verified
- Nov 2020
- First submitted
- 16 Oct 2020
- Last updated
- 6 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gait and Residual Pain at Different Physical Activity Intensities in High Tibial Osteotomy Patients and Healthy Controls
- ClinicalTrials.gov ID
- NCT04619550
- Acronym / sponsor ID
- BLS/19/07
- Conditions
- Osteoarthritis, Knee, Orthopedic Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- University of WinchesterUniversity, hospital or other
- Collaborators
- RTI Surgical Inc.
- Study start
- 15 Apr 2019 (actual)
- Primary completion
- 1 Nov 2019 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 6 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Exercise intensity | Other | Other: High tibial osteotomyJogging or walking at RPE 9, 11, 13, and 15 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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:
Key exclusion criteria (5 listed)
- Experimental group:
- Undergone other procedures simultaneous to the osteotomy
- Plate in-situ
- Control group:
- Previously undergone lower limb surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High tibial osteotomyRealignment surgery | Other | Exercise intensity |
Primary outcome
Spatiotemporal parameters of gait
Time frame: 9 months recruitment - 2 hours data collection per participant
Steps, cadence, speed (etc) measured using G-Walk wireless inertial sensor
Self-reported pain questionnaire
Time frame: 9 months recruitment - 2 hours data collection per participant
Visual analogues scale (0-10, where 0 = no pain and 10 = the worst imaginable pain)
1 secondary outcome
Self-reported knee function questionnaire
Time frame: 9 months recruitment - 2 hours data collection per participant
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
James Belsey, MA principal investigator
University of Winchester
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High tibial osteotomy in people with Osteoarthritis, Knee and Orthopedic Disorder, run by University of Winchester at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Spatiotemporal parameters of gait (time frame: 9 months recruitment - 2 hours data collection per participant). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2020.