NCT03898544

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
32

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Mar 2019

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 18, 2019

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

March 29, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 2, 2019

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 10, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 10, 2020

Completed
Last Updated

April 8, 2021

Status Verified

April 1, 2021

Enrollment Period

1.5 years

First QC Date

March 29, 2019

Last Update Submit

April 6, 2021

Conditions

Knee Arthroplasty, TotalGait Analysis

Keywords

gait kinematicsTKA

Outcome Measures

Primary Outcomes (4)

  • Femorotibial mechanical axis (varus, valgus) analysis

    These parameters are measured with the KneeKG system during the walking

    at 6 months postoperatively

  • range of motion (flexion, extension) analysis

    These parameters are measured with the KneeKG system during the walking

    at 6 months postoperatively

  • internal/external rotation analysis

    These parameter is measured with the KneeKG system during the walking

    at 6 months postoperatively

  • Walking speed

    These parameter is measured with the KneeKG system

    at 6 months postoperatively

Study Arms (2)

Group primary TKA

Patients operated of primary TKA Stryker for knee osteoarthritis.

Device: Group primary TKA

Group TKA revision

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

Device: Group TKA revision

Interventions

Group primary TKADEVICE

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).

Also known as: Total knee arthroplasty
Group primary TKA
Group TKA revisionDEVICE

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).

Also known as: Total knee arthroplasty
Group TKA revision

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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)

You may qualify if:

  • 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)

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hôpital de la Croix Rousse

Lyon, 69004, France

Location

MeSH Terms

Interventions

Arthroplasty, Replacement, Knee

Intervention Hierarchy (Ancestors)

Arthroplasty, ReplacementArthroplastyOrthopedic ProceduresSurgical Procedures, OperativePlastic Surgery ProceduresProsthesis Implantation

Study Officials

  • Sébastien Lustig, Pr

    Hospices Civils de Lyon

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 29, 2019

First Posted

April 2, 2019

Study Start

March 18, 2019

Primary Completion

September 10, 2020

Study Completion

September 10, 2020

Last Updated

April 8, 2021

Record last verified: 2021-04

Locations

FR(1)