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The Association of Gait Kinematics, Instability and Patient Reported Outcomes in Patients With Total Knee Replacement

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ClinicalTrials.gov Identifier: NCT03896191
Recruitment Status : Recruiting
First Posted : March 29, 2019
Last Update Posted : September 30, 2019
Sponsor:
Collaborator:
North Bristol NHS Trust
Information provided by (Responsible Party):
David Bruce, University of Bath

Brief 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.

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.


Condition or disease Intervention/treatment
Arthroplasty, Replacement, Knee Procedure: Revision TKR surgery Other: No intervention.

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:

  1. To investigate the effect of a revision TKR operation on gait kinematics, in patients who have a primary TKR and instability.
  2. To investigate the association between changes in gait kinematics and patient satisfaction, before and after revision TKR surgery for patients with instability.
  3. 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.


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Study Type : Observational
Estimated Enrollment : 42 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Association of Gait Kinematics, Instability and Patient Reported Outcomes in Patients With Total Knee Replacement
Actual Study Start Date : July 1, 2019
Estimated Primary Completion Date : February 1, 2021
Estimated Study Completion Date : February 1, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Knee Replacement

Group/Cohort Intervention/treatment
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).
Other: No intervention.
This study will also make a case-control comparison between patients with a stable primary TKR and an unstable primary TKR.

Unstable, dissatisfied primary TKR
Participants who are dissatisfied with their TKR, with instability (including instability due to aseptic loosening) and consequently awaiting revision TKR.
Procedure: Revision TKR 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.




Primary Outcome Measures :
  1. 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.

  2. Change from preoperative maximum knee flexion during swing. [ Time Frame: 1 year after surgery. ]
    Maximum knee flexion angle during the swing phase of gait.


Secondary Outcome Measures :
  1. Change from preoperative maximum knee flexion during stance. [ Time Frame: 8-12 weeks after surgery. ]
    Maximum knee flexion angle during the stance phase of gait.

  2. Change from preoperative maximum knee flexion during stance. [ Time Frame: 1 year after surgery. ]
    Maximum knee flexion angle during the stance phase of gait.

  3. Change from preoperative knee sagittal plane range of movement. [ Time Frame: 8-12 weeks after surgery. ]
    Knee sagittal plane range of movement during stance and swing phases of gait.

  4. Change from preoperative knee sagittal plane range of movement. [ Time Frame: 1 year after surgery. ]
    Knee sagittal plane range of movement during stance and swing phases of gait.

  5. Change from preoperative knee coronal plane range of movement. [ Time Frame: 8-12 weeks after surgery. ]
    Knee coronal plane range of movement during stance and swing phases of gait.

  6. Change from preoperative knee coronal plane range of movement. [ Time Frame: 1 year after surgery. ]
    Knee coronal plane range of movement during stance and swing phases of gait.

  7. Change from preoperative knee axial plane range of movement. [ Time Frame: 8-12 weeks after surgery. ]
    Knee axial plane range of movement during stance and swing phases of gait.

  8. Change from preoperative knee axial plane range of movement. [ Time Frame: 1 year after surgery. ]
    Knee axial plane range of movement during stance and swing phases of gait.

  9. Change from preoperative baseline in Oxford Knee Score. [ Time Frame: 8-12 weeks after surgery. ]
    Patient reported outcome measure. Minimum 0, Maximum 48 (48 being best).

  10. Change from preoperative baseline in Oxford Knee Score. [ Time Frame: 1 year after surgery. ]
    Patient reported outcome measure. Minimum 0, Maximum 48 (48 being best).

  11. Change from preoperative baseline in Knee injury and Osteoarthritis Outcome Score. [ Time Frame: 8-12 weeks after surgery. ]
    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.

  12. Change from preoperative baseline in Knee injury and Osteoarthritis Outcome Score. [ Time Frame: 1 year after surgery. ]
    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.

  13. Change from preoperative baseline in American Knee Society Score. [ Time Frame: 8-12 weeks after surgery. ]
    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).

  14. Change from preoperative baseline in American Knee Society Score. [ Time Frame: 1 year after surgery. ]
    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).

  15. Change from preoperative baseline in EQ-5D-5L questionnaire. [ Time Frame: 8-12 weeks after surgery. ]
    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).

  16. Change from preoperative baseline in EQ-5D-5L questionnaire. [ Time Frame: 1 year after surgery. ]
    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).


Other Outcome Measures:
  1. Statistical parametric mapping of sagittal plane knee kinematics. [ Time Frame: 8-12 weeks after surgery. ]
    Analysis of the whole gait cycle compared to preoperative kinematics.

  2. Statistical parametric mapping of sagittal plane knee kinematics. [ Time Frame: 1 year after surgery. ]
    Analysis of the whole gait cycle compared to preoperative kinematics.

  3. Statistical parametric mapping of coronal plane knee kinematics. [ Time Frame: 8-12 weeks after surgery. ]
    Analysis of the whole gait cycle compared to preoperative kinematics.

  4. Statistical parametric mapping of coronal plane knee kinematics. [ Time Frame: 1 year after surgery. ]
    Analysis of the whole gait cycle compared to preoperative kinematics.

  5. Statistical parametric mapping of axial plane knee kinematics. [ Time Frame: 8-12 weeks after surgery. ]
    Analysis of the whole gait cycle compared to preoperative kinematics.

  6. Statistical parametric mapping of axial plane knee kinematics. [ Time Frame: 1 year after surgery. ]
    Analysis of the whole gait cycle compared to preoperative kinematics.

  7. Variability of the primary and secondary outcome measures outlined above. [ Time Frame: 8-12 weeks after surgery. ]
    Variability compared to preoperative kinematics.

  8. Variability of the primary and secondary outcome measures outlined above. [ Time Frame: 1 year after surgery. ]
    Variability compared to preoperative kinematics.

  9. The above outcomes will also be applied to the hip and ankle joints. [ Time Frame: 8-12 weeks after surgery. ]
    These comparisons will assess change compared to preoperative kinematics.

  10. The above outcomes will also be applied to the hip and ankle joints. [ Time Frame: 1 year after surgery. ]
    These comparisons will assess change compared to preoperative kinematics.



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Patients attending orthopaedic knee clincs at a tertiary referral hospital.
Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

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.

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03896191


Contacts
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Contact: David J Bruce, BA, BMBCh +44 (0) 1225385176 djb203@bath.ac.uk
Contact: Ezio Preatoni, PhD +44 (0) 1225 383959 e.preatoni@bath.ac.uk

Locations
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United Kingdom
Southmead Hospital Recruiting
Bristol, United Kingdom, BS161RJ
Contact: David J Bruce, BA, BMBCh    +44 (0) 1225385176    david.bruce7@nhs.net   
Sub-Investigator: James Murray, MB BChir, MA         
Sub-Investigator: Michael Whitehouse, MBChB, PhD         
Sponsors and Collaborators
University of Bath
North Bristol NHS Trust
Investigators
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Principal Investigator: David J Bruce, BA, BMBCh University of Bath

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Responsible Party: David Bruce, Principal Investigator, University of Bath
ClinicalTrials.gov Identifier: NCT03896191     History of Changes
Other Study ID Numbers: 19-03607
First Posted: March 29, 2019    Key Record Dates
Last Update Posted: September 30, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: 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.
Supporting Materials: Study Protocol
Clinical Study Report (CSR)
Time Frame: Anonymised data will be made openly available to other researchers one year after completion of the study, or from the first publication using data from the study. The data will be stored on the Bath research archive for a period of at least 10 years.
Access Criteria: Anonymised data will be made available to bona fide researchers who will need to request access via the University of Bath research archive (https://researchdata.bath.ac.uk/).

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by David Bruce, University of Bath:
Total knee replacement
Revision knee surgery
Knee instability
Gait analysis
Patient reported outcome