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

Knee Arthroplasty, Total Clinical Trial

— Stryker-KneeKG  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03898544
• Other study ID #: 69HCL19_0089
• Secondary ID: 2019-A00478-49
• Status: Completed
• 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
• 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

Related Conditions & MeSH terms

• Gait Analysis
• Knee Arthroplasty, Total

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