Arthroplasty, Replacement, KneeNCT03896191
The Association of Gait Kinematics, Instability and Patient Reported Outcomes in Patients With Total Knee Replacement
An observational study of Arthroplasty, Replacement, Knee, run by University of Bath at 1 site in United Kingdom.
Trial summary
It is unclear why 20% of patients with total knee replacements (TKR) are dissatisfied. Few studies have specifically assessed the way people walk ('gait') with an 'unhappy' or unstable knee or following re-do ('revision') TKR surgery. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Arthroplasty, Replacement, Knee
- What is being tested?
- Revision TKR surgery
- Type of treatment
- Surgery or procedure
- How many people
- 38 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Jul 2019to 21 Feb 2022
- Phase
- Observational
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Patients attending orthopaedic knee clincs at a tertiary referral hospital.
Who may be able to join
- Patients awaiting revision TKR due to instability:
- Patients who have a primary total knee replacement.
- Patients who have an unstable knee replacement, as determined by the surgical team.
- Patients who are being listed for a revision total knee replacement.
- Primary TKR without instability:
- Patients with a primary total knee replacement.
- Patients at least one year after their primary total knee replacement operation.
Who cannot join
- Patients awaiting revision TKR due to instability:
- Patients who have suspected infection of the TKR.
- Patients who are awaiting a two-stage revision procedure.
- Patients who can walk less than one minute at a time.
- Patients who can walk for less than five minutes with rests.
- Patient who are not able to give informed consent.
Show all 14Show fewer
- Primary TKR without instability:
- Patients who have had a previous revision of the total knee replacement.
- Patients who have an unstable knee replacement, as determined by the surgical team.
- Patients who have aseptic loosening or wear, as determined by the surgical team.
- Patients who are not satisfied with their TKR (as determined by the study specific questionnaire).
- Patients who can walk for less than one minute at a time.
- Patients who can walk for less than five minutes with rests.
- Patient who are not able to give informed consent.
Trial locations and contacts
1 site in 1 country.
About this study
It is unclear why 20% of patients with total knee replacements (TKR) are dissatisfied. Few studies have specifically assessed the way people walk ('gait') with an 'unhappy' or unstable knee or following re-do ('revision') TKR surgery.
The investigators conjecture that people having re-do TKR surgery because their knee is unstable will have altered walking patterns (for example, less bending of the knee) before and after surgery, and that these changes are related to how satisfied the patient is with their knee. The investigators will also examine whether there are differences in the way people walk with an unstable knee replacement or with a stable knee replacement, in comparison to people who do not have a knee replacement.
This exploratory project will use 3D infrared cameras to analyse differences in walking patterns and whether there is associated change in patient satisfaction. If an association exists, the data from this study may help to develop alternative measures of outcomes, in order to guide treatment decisions.
Read the detailed description
The effect of TKR instability on gait is poorly understood. How does revision TKR surgery for instability alter gait and is there an associated change in patient satisfaction? Are there differences in gait between patients with an unstable TKR and a stable TKR? The objectives of this study are:
- To investigate the effect of a revision TKR operation on gait kinematics, in patients who have a primary TKR and instability.
- To investigate the association between changes in gait kinematics and patient satisfaction, before and after revision TKR surgery for patients with instability.
- To investigate differences in gait kinematics between dissatisfied patients with an unstable primary TKR, satisfied patients with a stable primary TKR and people who do not have a knee replacement.
The first part of the investigation will tackle the first two objectives and follow patients who are having a revision TKR due to an unstable knee before and after their operation. The second part will then compare these patients to those with a primary TKR and no instability and to a control group of participants who do not have knee replacements ('native knees') and do not have difficulty walking. This will determine the difference in kinematics between a native knee and a TKR with and without instability.
Age, height, weight, leg lengths, measurements of the TKR position on imaging (taken as part of routine clinical practice) and patient reported outcome scores will be documented.
The gait assessments will be carried out in the outpatient clinic or physiotherapy department. These patients will have their walking gait assessed using a treadmill-based portable 3D infrared camera system (Vicon Ltd, Oxford, UK). The raw data will be processed by Run3D (Run3D Ltd, Oxford, UK) and Visual3D (C-motion Inc, MD, USA) to calculate knee joint angles.
Analysis will focus on within subject (part 1) and between subject differences (part 2). The questions are novel and data will be largely exploratory. Measures, differences and correlations will be presented using descriptive statistics and, where appropriate, correlation and regression coefficients. Where possible, inferential statistics (such as t-tests) will formally test differences in knee kinematic measures and associations with PROMS. Statistical parametric mapping will be applied to analyse continuous quantities over the gait cycle. Published research indicates an effect size of 1.0 may be expected. This suggests sample sizes between 11 and 42 should be sufficient to determine statistically significant two-tailed differences (alpha=0.05, beta=0.2) within subjects or between groups, according to the comparison being assessed. A sample of 42 patients is targeted.
In the longer term, this study will enable a better understanding of the functional biomechanics of TKR instability and potentially develop an alternative quantitative measurement of outcome and instability.
- Conditions
- Arthroplasty, Replacement, Knee
- Being tested
- Revision TKR surgery, No intervention.
- Keywords
- Total knee replacement, Revision knee surgery, Knee instability, Gait analysis, Patient reported outcome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Revision TKR surgeryProcedure or surgery
This study will follow the cohort of patients who have an unstable primary TKR with which they are dissatisfied. They will be assessed before and after their revision TKR surgery.
No intervention.Other
This study will also make a case-control comparison between patients with a stable primary TKR and an unstable primary TKR.
| Study group | Role | What they receive |
|---|---|---|
| Stable, satisfied primary TKR | Participants who have a stable TKR (as assessed by the surgical team) and are satisfied with their knee replacement (as assessed by a questionnaire). Receives: Other: No intervention. | |
| Unstable, dissatisfied primary TKR | Participants who are dissatisfied with their TKR, with instability (including instability due to aseptic loosening) and consequently awaiting revision TKR. Receives: Procedure: Revision TKR surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from preoperative maximum knee flexion during swing.
Maximum knee flexion angle during the swing phase of gait.
Measured: 8-12 weeks after surgery.
Change from preoperative maximum knee flexion during swing.
Maximum knee flexion angle during the swing phase of gait.
Measured: 1 year after surgery.
Secondary outcomes (16)
Change from preoperative maximum knee flexion during stance.
Maximum knee flexion angle during the stance phase of gait.
Measured: 8-12 weeks after surgery.
Change from preoperative maximum knee flexion during stance.
Maximum knee flexion angle during the stance phase of gait.
Measured: 1 year after surgery.
Change from preoperative knee sagittal plane range of movement.
Knee sagittal plane range of movement during stance and swing phases of gait.
Measured: 8-12 weeks after surgery.
Change from preoperative knee sagittal plane range of movement.
Knee sagittal plane range of movement during stance and swing phases of gait.
Measured: 1 year after surgery.
Change from preoperative knee coronal plane range of movement.
Knee coronal plane range of movement during stance and swing phases of gait.
Measured: 8-12 weeks after surgery.
Change from preoperative knee coronal plane range of movement.
Knee coronal plane range of movement during stance and swing phases of gait.
Measured: 1 year after surgery.
Change from preoperative knee axial plane range of movement.
Knee axial plane range of movement during stance and swing phases of gait.
Measured: 8-12 weeks after surgery.
Change from preoperative knee axial plane range of movement.
Knee axial plane range of movement during stance and swing phases of gait.
Measured: 1 year after surgery.
Change from preoperative baseline in Oxford Knee Score.
Patient reported outcome measure. Minimum 0, Maximum 48 (48 being best).
Measured: 8-12 weeks after surgery.
Change from preoperative baseline in Oxford Knee Score.
Patient reported outcome measure. Minimum 0, Maximum 48 (48 being best).
Measured: 1 year after surgery.
Change from preoperative baseline in Knee injury and Osteoarthritis Outcome Score.
Patient reported outcome measure. Minimum 0, Maximum 100 (100 being best). Subscales (pain, symptoms, function, sports and recreation, quality of life) are transformed to the 0-100 overall scale.
Measured: 8-12 weeks after surgery.
Change from preoperative baseline in Knee injury and Osteoarthritis Outcome Score.
Patient reported outcome measure. Minimum 0, Maximum 100 (100 being best). Subscales (pain, symptoms, function, sports and recreation, quality of life) are transformed to the 0-100 overall scale.
Measured: 1 year after surgery.
Change from preoperative baseline in American Knee Society Score.
Patient reported outcome measure with two subscales. Subscales are the Knee Society Score, Minimum 0, Maximum 100 (100 being best); and Knee Society Function Score Minimum 0, Maximum 100 (100 being best).
Measured: 8-12 weeks after surgery.
Change from preoperative baseline in American Knee Society Score.
Patient reported outcome measure with two subscales. Subscales are the Knee Society Score, Minimum 0, Maximum 100 (100 being best); and Knee Society Function Score Minimum 0, Maximum 100 (100 being best).
Measured: 1 year after surgery.
Change from preoperative baseline in EQ-5D-5L questionnaire.
Patient reported outcome measure. Subcategories (mobility, self-care, activity, pain, anxiety) scored between 1 and 5 (1 being best) and a visual analog score between 0 and 100 (100 being best).
Measured: 8-12 weeks after surgery.
Change from preoperative baseline in EQ-5D-5L questionnaire.
Patient reported outcome measure. Subcategories (mobility, self-care, activity, pain, anxiety) scored between 1 and 5 (1 being best) and a visual analog score between 0 and 100 (100 being best).
Measured: 1 year after surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2019
- Study start1 Jul 2019
- Primary completion21 Feb 2022
- Study completion21 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Arthroplasty, Replacement, 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Bath
- Sponsor type
- University, hospital or other
- Collaborators
- North Bristol NHS Trust
- Responsible party
- Principal investigator, David Bruce, University of Bath
- Investigators
- David J Bruce, BA, BMBCh, Principal investigator, University of Bath
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03896191
- Sponsor's protocol ID
- 19-03607
- Status last verified
- May 2022
- First submitted
- 26 Mar 2019
- Last updated
- 23 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The final anonymised raw and processed datasets will be made available for future research, as specified in the University of Bath's data management guidelines.
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Association of Gait Kinematics, Instability and Patient Reported Outcomes in Patients With Total Knee Replacement
- ClinicalTrials.gov ID
- NCT03896191
- Acronym / sponsor ID
- 19-03607
- Conditions
- Arthroplasty, Replacement, Knee
- Keywords
- Total knee replacement, Revision knee surgery, Knee instability, Gait analysis, Patient reported outcome
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- University of BathUniversity, hospital or other
- Collaborators
- North Bristol NHS Trust
- Study start
- 1 Jul 2019 (actual)
- Primary completion
- 21 Feb 2022 (actual)
- Study completion
- 21 Feb 2022 (actual)
- First posted
- 29 Mar 2019 (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.
It is unclear why 20% of patients with total knee replacements (TKR) are dissatisfied. Few studies have specifically assessed the way people walk ('gait') with an 'unhappy' or unstable knee or following re-do ('revision') TKR surgery.
The investigators conjecture that people having re-do TKR surgery because their knee is unstable will have altered walking patterns (for example, less bending of the knee) before and after surgery, and that these changes are related to how satisfied the patient is with their knee. The investigators will also examine whether there are differences in the way people walk with an unstable knee replacement or with a stable knee replacement, in comparison to people who do not have a knee replacement.
This exploratory project will use 3D infrared cameras to analyse differences in walking patterns and whether there is associated change in patient satisfaction. If an association exists, the data from this study may help to develop alternative measures of outcomes, in order to guide treatment decisions.
Detailed description
The effect of TKR instability on gait is poorly understood. How does revision TKR surgery for instability alter gait and is there an associated change in patient satisfaction? Are there differences in gait between patients with an unstable TKR and a stable TKR? The objectives of this study are:
- To investigate the effect of a revision TKR operation on gait kinematics, in patients who have a primary TKR and instability.
- To investigate the association between changes in gait kinematics and patient satisfaction, before and after revision TKR surgery for patients with instability.
- To investigate differences in gait kinematics between dissatisfied patients with an unstable primary TKR, satisfied patients with a stable primary TKR and people who do not have a knee replacement.
The first part of the investigation will tackle the first two objectives and follow patients who are having a revision TKR due to an unstable knee before and after their operation. The second part will then compare these patients to those with a primary TKR and no instability and to a control group of participants who do not have knee replacements ('native knees') and do not have difficulty walking. This will determine the difference in kinematics between a native knee and a TKR with and without instability.
Age, height, weight, leg lengths, measurements of the TKR position on imaging (taken as part of routine clinical practice) and patient reported outcome scores will be documented.
The gait assessments will be carried out in the outpatient clinic or physiotherapy department. These patients will have their walking gait assessed using a treadmill-based portable 3D infrared camera system (Vicon Ltd, Oxford, UK). The raw data will be processed by Run3D (Run3D Ltd, Oxford, UK) and Visual3D (C-motion Inc, MD, USA) to calculate knee joint angles.
Analysis will focus on within subject (part 1) and between subject differences (part 2). The questions are novel and data will be largely exploratory. Measures, differences and correlations will be presented using descriptive statistics and, where appropriate, correlation and regression coefficients. Where possible, inferential statistics (such as t-tests) will formally test differences in knee kinematic measures and associations with PROMS. Statistical parametric mapping will be applied to analyse continuous quantities over the gait cycle. Published research indicates an effect size of 1.0 may be expected. This suggests sample sizes between 11 and 42 should be sufficient to determine statistically significant two-tailed differences (alpha=0.05, beta=0.2) within subjects or between groups, according to the comparison being assessed. A sample of 42 patients is targeted.
In the longer term, this study will enable a better understanding of the functional biomechanics of TKR instability and potentially develop an alternative quantitative measurement of outcome and instability.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Stable, satisfied primary TKR | – | Other: No intervention.Participants who have a stable TKR (as assessed by the surgical team) and are satisfied with their knee replacement (as assessed by a questionnaire). |
| Unstable, dissatisfied primary TKR | – | Procedure: Revision TKR surgeryParticipants who are dissatisfied with their TKR, with instability (including instability due to aseptic loosening) and consequently awaiting revision TKR. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients attending orthopaedic knee clincs at a tertiary referral hospital.
Key inclusion criteria (7 listed)
- Patients who have a primary total knee replacement.
- Patients who have an unstable knee replacement, as determined by the surgical team.
- Patients who are being listed for a revision total knee replacement.
- Patients with a primary total knee replacement.
- Patients at least one year after their primary total knee replacement operation.
Key exclusion criteria (14 listed)
- Patients who have suspected infection of the TKR.
- Patients who are awaiting a two-stage revision procedure.
- Patients who can walk less than one minute at a time.
- Patients who can walk for less than five minutes with rests.
- Patient who are not able to give informed consent.
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 |
|---|---|---|
| Revision TKR surgeryThis study will follow the cohort of patients who have an unstable primary TKR with which they are dissatisfied. They will be assessed before and after their revision TKR surgery. | Procedure or surgery | Unstable, dissatisfied primary TKR |
| No intervention.This study will also make a case-control comparison between patients with a stable primary TKR and an unstable primary TKR. | Other | Stable, satisfied primary TKR |
Primary outcome
Change from preoperative maximum knee flexion during swing.
Time frame: 8-12 weeks after surgery.
Maximum knee flexion angle during the swing phase of gait.
Change from preoperative maximum knee flexion during swing.
Time frame: 1 year after surgery.
Maximum knee flexion angle during the swing phase of gait.
16 secondary outcomes
Change from preoperative maximum knee flexion during stance.
Time frame: 8-12 weeks after surgery.
Change from preoperative maximum knee flexion during stance.
Time frame: 1 year after surgery.
Change from preoperative knee sagittal plane range of movement.
Time frame: 8-12 weeks after surgery.
Change from preoperative knee sagittal plane range of movement.
Time frame: 1 year after surgery.
Change from preoperative knee coronal plane range of movement.
Time frame: 8-12 weeks after surgery.
Change from preoperative knee coronal plane range of movement.
Time frame: 1 year after surgery.
Change from preoperative knee axial plane range of movement.
Time frame: 8-12 weeks after surgery.
Change from preoperative knee axial plane range of movement.
Time frame: 1 year after surgery.
Change from preoperative baseline in Oxford Knee Score.
Time frame: 8-12 weeks after surgery.
Change from preoperative baseline in Oxford Knee Score.
Time frame: 1 year after surgery.
Change from preoperative baseline in Knee injury and Osteoarthritis Outcome Score.
Time frame: 8-12 weeks after surgery.
Change from preoperative baseline in Knee injury and Osteoarthritis Outcome Score.
Time frame: 1 year after surgery.
Change from preoperative baseline in American Knee Society Score.
Time frame: 8-12 weeks after surgery.
Change from preoperative baseline in American Knee Society Score.
Time frame: 1 year after surgery.
Change from preoperative baseline in EQ-5D-5L questionnaire.
Time frame: 8-12 weeks after surgery.
Change from preoperative baseline in EQ-5D-5L questionnaire.
Time frame: 1 year after surgery.
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 23 May 2022.
- Individual participant dataSharing planned: Yes. The final anonymised raw and processed datasets will be made available for future research, as specified in the University of Bath's data management guidelines.
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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.
David J Bruce, BA, BMBCh principal investigator
University of Bath
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Arthroplasty, Replacement, Knee, run by University of Bath 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 14 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 23 May 2022. 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?
Change from preoperative maximum knee flexion during swing. (time frame: 8-12 weeks after surgery.). 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 23 May 2022.