Knee Arthroplasty, Total Clinical Trial
— Stryker-KneeKGOfficial title:
Assessment at Short Term of the Gait Kinematics After Primary TKA (Stryker) Versus After Revision TKA. Prospective and Controlled Study.
Verified date | April 2021 |
Source | Hospices Civils de Lyon |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
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 |
Country | Name | City | State |
---|---|---|---|
France | Hôpital de la Croix Rousse | Lyon |
Lead Sponsor | Collaborator |
---|---|
Hospices Civils de Lyon | Stryker Nordic |
France,
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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