Not provided
Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2019-A00478-49 | Other Identifier | ANSM |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Stryker Nordic | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group primary TKA | Patients operated of primary TKA Stryker for knee osteoarthritis. |
| |
| Group TKA revision | Patients operated of a first revision of TKA for a mechanical failure, with the revision Stryker TKA |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Group primary TKA | Device | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
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)
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Sébastien Lustig, Pr | Hospices Civils de Lyon | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hôpital de la Croix Rousse | Lyon | 69004 | France |
Not provided
| ID | Term |
|---|---|
| D019645 | Arthroplasty, Replacement, Knee |
| ID | Term |
|---|---|
| D019643 | Arthroplasty, Replacement |
| D001178 | Arthroplasty |
| D019637 | Orthopedic Procedures |
| D013514 | Surgical Procedures, Operative |
Not provided
Not provided
Not provided
Not provided
Not provided
|
|
| Group TKA revision | Device | 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). |
|
|
| D019651 | Plastic Surgery Procedures |
| D019919 | Prosthesis Implantation |