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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03898544
Other study ID # 69HCL19_0089
Secondary ID 2019-A00478-49
Status Completed
Phase
First received
Last updated
Start date March 18, 2019
Est. completion date September 10, 2020

Study information

Verified date April 2021
Source Hospices Civils de Lyon
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 32
Est. completion date September 10, 2020
Est. primary completion date September 10, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


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).
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).

Locations

Country Name City State
France Hôpital de la Croix Rousse Lyon

Sponsors (2)

Lead Sponsor Collaborator
Hospices Civils de Lyon Stryker Nordic

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Femorotibial mechanical axis (varus, valgus) analysis These parameters are measured with the KneeKG system during the walking at 6 months postoperatively
Primary range of motion (flexion, extension) analysis These parameters are measured with the KneeKG system during the walking at 6 months postoperatively
Primary internal/external rotation analysis These parameter is measured with the KneeKG system during the walking at 6 months postoperatively
Primary Walking speed These parameter is measured with the KneeKG system at 6 months postoperatively
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