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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 : Recruiting
First Posted : April 2, 2019
Last Update Posted : January 13, 2020
Sponsor:
Collaborator:
Stryker Nordic
Information provided by (Responsible Party):
Hospices Civils de Lyon

Tracking Information
First Submitted Date March 29, 2019
First Posted Date April 2, 2019
Last Update Posted Date January 13, 2020
Actual Study Start Date March 18, 2019
Estimated Primary Completion Date March 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: March 29, 2019)
  • Femorotibial mechanical axis (varus, valgus) analysis [ Time Frame: at 6 months postoperatively ]
    These parameters are measured with the KneeKG system during the walking
  • range of motion (flexion, extension) analysis [ Time Frame: at 6 months postoperatively ]
    These parameters are measured with the KneeKG system during the walking
  • internal/external rotation analysis [ Time Frame: at 6 months postoperatively ]
    These parameter is measured with the KneeKG system during the walking
  • Walking speed [ Time Frame: at 6 months postoperatively ]
    These parameter is measured with the KneeKG system
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Gait Kinematics After Primary Total Knee Arthroplasty (TKA) Versus Revision TKA
Official Title Assessment at Short Term of the Gait Kinematics After Primary TKA (Stryker) Versus After Revision TKA. Prospective and Controlled Study.
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.

Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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)

Condition
  • Knee Arthroplasty, Total
  • Gait Analysis
Intervention
  • 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
  • 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
Study Groups/Cohorts
  • Group primary TKA
    Patients operated of primary TKA Stryker for knee osteoarthritis.
    Intervention: Device: Group primary TKA
  • Group TKA revision
    Patients operated of a first revision of TKA for a mechanical failure, with the revision Stryker TKA
    Intervention: Device: Group TKA revision
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: March 29, 2019)
38
Original Estimated Enrollment Same as current
Estimated Study Completion Date March 2021
Estimated Primary Completion Date March 2021   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Cécile Batailler, Dr 426109294 ext +33 cecile.batailler@chu-lyon.fr
Listed Location Countries France
Removed Location Countries  
 
Administrative Information
NCT Number NCT03898544
Other Study ID Numbers 69HCL19_0089
2019-A00478-49 ( Other Identifier: ANSM )
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Responsible Party Hospices Civils de Lyon
Study Sponsor Hospices Civils de Lyon
Collaborators Stryker Nordic
Investigators
Principal Investigator: Sébastien Lustig, Pr Hospices Civils de Lyon
PRS Account Hospices Civils de Lyon
Verification Date January 2020