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

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ClinicalTrials.gov Identifier: NCT03898544
Recruitment Status : Not yet recruiting
First Posted : April 2, 2019
Last Update Posted : April 2, 2019
Sponsor:
Collaborator:
Stryker Nordic
Information provided by (Responsible Party):
Hospices Civils de Lyon

Brief Summary:

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.


Condition or disease Intervention/treatment
Knee Arthroplasty, Total Gait Analysis Device: Group primary TKA Device: Group TKA revision

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Study Type : Observational
Estimated Enrollment : 38 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Assessment at Short Term of the Gait Kinematics After Primary TKA (Stryker) Versus After Revision TKA. Prospective and Controlled Study.
Estimated Study Start Date : April 2019
Estimated Primary Completion Date : April 2021
Estimated Study Completion Date : April 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Knee Replacement

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 Name: 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 Name: Total knee arthroplasty




Primary Outcome Measures :
  1. Femorotibial mechanical axis (varus, valgus) analysis [ Time Frame: at 6 months postoperatively ]
    These parameters are measured with the KneeKG system during the walking

  2. range of motion (flexion, extension) analysis [ Time Frame: at 6 months postoperatively ]
    These parameters are measured with the KneeKG system during the walking

  3. internal/external rotation analysis [ Time Frame: at 6 months postoperatively ]
    These parameter is measured with the KneeKG system during the walking

  4. Walking speed [ Time Frame: at 6 months postoperatively ]
    These parameter is measured with the KneeKG system



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)

Criteria

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

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): NCT03898544


Contacts
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Contact: Cécile Batailler, Dr 426109294 ext +33 cecile.batailler@chu-lyon.fr

Locations
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France
Hôpital de la Croix Rousse Not yet recruiting
Lyon, France, 69004
Contact: Cécile Batailler         
Sub-Investigator: Cécile Batailler         
Principal Investigator: Sébastien Lustig         
Sponsors and Collaborators
Hospices Civils de Lyon
Stryker Nordic
Investigators
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Principal Investigator: Sébastien Lustig, Pr Hospices Civils de Lyon

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Responsible Party: Hospices Civils de Lyon
ClinicalTrials.gov Identifier: NCT03898544     History of Changes
Other Study ID Numbers: 69HCL19_0089
2019-A00478-49 ( Other Identifier: ANSM )
First Posted: April 2, 2019    Key Record Dates
Last Update Posted: April 2, 2019
Last Verified: March 2019

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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 Hospices Civils de Lyon:
gait kinematics
TKA