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

NCT03896191 | Completed

• 1 other identifier: 19-03607
• Study Type: observational
• Target: 38
• Locations: 1 country
• Sites: 1

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.

Conditions

Arthroplasty, Replacement, Knee

Keywords

Total knee replacement; Revision knee surgery; Knee instability; Gait analysis; Patient reported outcome

Outcome Measures

Primary Outcomes (2)

• Change from preoperative maximum knee flexion during swing.

  Maximum knee flexion angle during the swing phase of gait.

  8-12 weeks after surgery.

• Change from preoperative maximum knee flexion during swing.

  Maximum knee flexion angle during the swing phase of gait.

  1 year after surgery.

Secondary Outcomes (16)

• Change from preoperative maximum knee flexion during stance.

  8-12 weeks after surgery.

• Change from preoperative maximum knee flexion during stance.

  1 year after surgery.

• Change from preoperative knee sagittal plane range of movement.

  8-12 weeks after surgery.

• Change from preoperative knee sagittal plane range of movement.

  1 year after surgery.

• Change from preoperative knee coronal plane range of movement.

  8-12 weeks after surgery.

Other Outcomes (10)

• Statistical parametric mapping of sagittal plane knee kinematics.

  8-12 weeks after surgery.

• Statistical parametric mapping of sagittal plane knee kinematics.

  1 year after surgery.

• Statistical parametric mapping of coronal plane knee kinematics.

  8-12 weeks after surgery.

Study Arms (2)

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.

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

Interventions

Revision TKR surgery PROCEDURE

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.

Unstable, dissatisfied primary TKR

No intervention. OTHER

This study will also make a case-control comparison between patients with a stable primary TKR and an unstable primary TKR.

Stable, satisfied primary TKR

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients attending orthopaedic knee clincs at a tertiary referral hospital.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Bath: lead
• North Bristol NHS Trust: collaborator

Study Sites (1)

Southmead Hospital

Bristol, BS161RJ, United Kingdom

Location

Study Officials

• David J Bruce, BA, BMBCh

  University of Bath

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 26, 2019
• First Posted: March 29, 2019
• Study Start: July 1, 2019
• Primary Completion: February 21, 2022
• Study Completion: February 21, 2022
• Last Updated: May 23, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, 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/).

Locations

GB (1)