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Completed

NCT Number: NCT03898544

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

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.

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Key information

Conditions

Knee Arthroplasty, Total Gait Analysis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hôpital de la Croix Rousse

Lyon, 69004, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Group primary TKA

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).

Other names: Total knee arthroplasty

Group TKA revision

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).

Other names: Total knee arthroplasty

Primary outcomes

  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

Sponsors and collaborators

Lead sponsor

Hospices Civils de Lyon

Other

Collaborators

  • Stryker Nordic

Registry information

Official study title

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

Acronym: Stryker-KneeKG

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Apr 2, 2019
Registry last updated
Apr 8, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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