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

NCT ID: NCT03898544

Last Updated: 2021-04-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

32 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-03-18

Study Completion Date

2020-09-10

Brief Summary

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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.

Detailed Description

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Conditions

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Knee Arthroplasty, Total Gait Analysis

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Group primary TKA

Patients operated of primary TKA Stryker for knee osteoarthritis.

Group primary TKA

Intervention Type DEVICE

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).

Group TKA revision

Patients operated of a first revision of TKA for a mechanical failure, with the revision Stryker TKA

Group TKA revision

Intervention Type DEVICE

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).

Interventions

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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).

Intervention Type 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).

Intervention Type DEVICE

Other Intervention Names

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Total knee arthroplasty Total knee arthroplasty

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Stryker Nordic

INDUSTRY

Sponsor Role collaborator

Hospices Civils de Lyon

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Sébastien Lustig, Pr

Role: PRINCIPAL_INVESTIGATOR

Hospices Civils de Lyon

Locations

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Hôpital de la Croix Rousse

Lyon, , France

Site Status

Countries

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France

Other Identifiers

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2019-A00478-49

Identifier Type: OTHER

Identifier Source: secondary_id

69HCL19_0089

Identifier Type: -

Identifier Source: org_study_id

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