Gait Kinematics After Primary Total Knee Arthroplasty (TKA) Versus Revision TKA (Stryker-KneeKG)

April 6, 2021 updated by: Hospices Civils de Lyon

Assessment at Short Term of the Gait Kinematics After Primary TKA (Stryker) Versus After Revision TKA. Prospective and Controlled Study.

The functional outcomes after TKA are satisfying with a full recovery at 6 months - 1 year. Nevertheless, the revisions of TKA have often lower functional results than primary TKA with a long delay of recovery. The Stryker TKA present the same device for primary TKA and for revision.

The aim of this study is to compare the gait kinematics at 6 months after primary Stryker TKA or Revision Stryker TKA to assess if the objective outcomes are similar with this device.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

32

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Lyon, France, 69004
        • Hopital de la Croix Rousse

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Primary TKA group: symptomatic femorotibial osteoarthritis, with an indication of primary TKA (as Triathlon Stryker)

Revision group: first TKA removal in 1 step for mechanical failure, by a revision TKA (as Triathlon Stryker)

Description

Inclusion Criteria:

  • Primary TKA group: symptomatic femorotibial osteoarthritis, with an indication of primary TKA (as Triathlon Stryker)
  • Revision group: first TKA removal in 1 step for mechanical failure, by a revision TKA (as Triathlon Stryker)

Exclusion Criteria:

  • Septic failure
  • Second or more failure in the revision group
  • Associated surgical procedure as osteotomy, allograft…
  • Not full weight bearing postoperatively
  • Refusal to participate

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Group primary TKA
Patients operated of primary TKA Stryker for knee osteoarthritis.
Device: Group primary TKA

Assessment by gait kinematics analysis The total knee arthroplasty will be performed as usual with the dedicated instrumentation.

The gait kinematics analysis will be performed with the KneeKG system on a treadmill, with infrared sensors (IR) on the leg. This system is not invasive. The IR sensors are positioned on the pelvis, the distal femur and the tibial crest. This system records the flexion/extension, the varus/valgus and the rotation during the walking (1 minute of walking).

Other Names:
  • Total knee arthroplasty
Group TKA revision
Patients operated of a first revision of TKA for a mechanical failure, with the revision Stryker TKA
Device: Group TKA revision

Assessment by gait kinematics analysis The total knee arthroplasty will be performed as usual with the dedicated instrumentation.

The gait kinematics analysis will be performed with the KneeKG system on a treadmill, with infrared sensors on the leg. This system is not invasive. The IR sensors are positioned on the pelvis, the distal femur and the tibial crest. This system records the flexion/extension, the varus/valgus and the rotation during the walking (1 minute of walking).

Other Names:
  • Total knee arthroplasty

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Femorotibial mechanical axis (varus, valgus) analysis
Time Frame: at 6 months postoperatively
These parameters are measured with the KneeKG system during the walking
at 6 months postoperatively
range of motion (flexion, extension) analysis
Time Frame: at 6 months postoperatively
These parameters are measured with the KneeKG system during the walking
at 6 months postoperatively
internal/external rotation analysis
Time Frame: at 6 months postoperatively
These parameter is measured with the KneeKG system during the walking
at 6 months postoperatively
Walking speed
Time Frame: at 6 months postoperatively
These parameter is measured with the KneeKG system
at 6 months postoperatively

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospices Civils de Lyon

Collaborators

Stryker Nordic

Investigators

  • Principal Investigator: Sébastien Lustig, Pr, Hospices Civils de Lyon

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 18, 2019

Primary Completion (Actual)

September 10, 2020

Study Completion (Actual)

September 10, 2020

Study Registration Dates

First Submitted

March 29, 2019

First Submitted That Met QC Criteria

March 29, 2019

First Posted (Actual)

April 2, 2019

Study Record Updates

Last Update Posted (Actual)

April 8, 2021

Last Update Submitted That Met QC Criteria

April 6, 2021

Last Verified

April 1, 2021

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 69HCL19_0089
  • 2019-A00478-49 (Other Identifier: ANSM)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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