Knee Arthroplasty, TotalStryker-KneeKGNCT03898544
Gait Kinematics After Primary Total Knee Arthroplasty (TKA) Versus Revision TKA
An observational study of Knee Arthroplasty, Total and Gait Analysis, run by Hospices Civils de Lyon at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Knee Arthroplasty, Total, Gait Analysis
- What is being tested?
- Group primary TKA and Group TKA revision
- Type of treatment
- Medical device
- How many people
- 32 participants
- Where
- 1 siteFrance
- Study dates
- 18 Mar 2019to 10 Sep 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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)
Who may be able to join
- 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)
Who cannot join
- Septic failure
- Second or more failure in the revision group
- Associated surgical procedure as osteotomy, allograft…
- Not full weight bearing postoperatively
- Refusal to participate
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Assessment at Short Term of the Gait Kinematics After Primary TKA (Stryker) Versus After Revision TKA. Prospective and Controlled Study.
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.
- Conditions
- Knee Arthroplasty, Total, Gait Analysis
- Being tested
- Group primary TKA, Group TKA revision
- Keywords
- gait kinematics, TKA
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group primary TKADevice
Also called Total knee arthroplasty
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 revisionDevice
Also called Total knee arthroplasty
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).
| Study group | Role | What they receive |
|---|---|---|
| Group primary TKA | Patients operated of primary TKA Stryker for knee osteoarthritis. Receives: Device: Group primary TKA | |
| Group TKA revision | Patients operated of a first revision of TKA for a mechanical failure, with the revision Stryker TKA Receives: Device: Group TKA revision |
What is being measured
The primary outcome is the main question the study is designed to answer.
Femorotibial mechanical axis (varus, valgus) analysis
These parameters are measured with the KneeKG system during the walking
Measured: at 6 months postoperatively
range of motion (flexion, extension) analysis
These parameters are measured with the KneeKG system during the walking
Measured: at 6 months postoperatively
internal/external rotation analysis
These parameter is measured with the KneeKG system during the walking
Measured: at 6 months postoperatively
Walking speed
These parameter is measured with the KneeKG system
Measured: at 6 months postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2019
- Study start18 Mar 2019
- Primary completion10 Sep 2020
- Study completion10 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee Arthroplasty, TotalStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Collaborators
- Stryker Nordic
- Responsible party
- Sponsor
- Investigators
- Sébastien Lustig, Pr, Principal investigator, Hospices Civils de Lyon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03898544
- Sponsor's protocol ID
- 69HCL19_0089
- Other IDs
- 2019-A00478-49
- Acronym
- Stryker-KneeKG
- Status last verified
- Apr 2021
- First submitted
- 29 Mar 2019
- Last updated
- 8 Apr 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment at Short Term of the Gait Kinematics After Primary TKA (Stryker) Versus After Revision TKA. Prospective and Controlled Study.
- ClinicalTrials.gov ID
- NCT03898544
- Acronym / sponsor ID
- Stryker-KneeKG / 69HCL19_0089
- Conditions
- Knee Arthroplasty, Total, Gait Analysis
- Keywords
- gait kinematics, TKA
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Collaborators
- Stryker Nordic
- Study start
- 18 Mar 2019 (actual)
- Primary completion
- 10 Sep 2020 (actual)
- Study completion
- 10 Sep 2020 (actual)
- First posted
- 2 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group primary TKA | – | Device: Group primary TKAPatients operated of primary TKA Stryker for knee osteoarthritis. |
| Group TKA revision | – | Device: Group TKA revisionPatients operated of a first revision of TKA for a mechanical failure, with the revision Stryker TKA |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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)
Key inclusion criteria (2 listed)
- 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)
Key exclusion criteria (5 listed)
- Septic failure
- Second or more failure in the revision group
- Associated surgical procedure as osteotomy, allograft…
- Not full weight bearing postoperatively
- Refusal to participate
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Group primary TKAAlso: Total knee arthroplastyAssessment 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). | Device | Group primary TKA |
| Group TKA revisionAlso: Total knee arthroplastyAssessment 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). | Device | Group TKA revision |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sébastien Lustig, Pr principal investigator
Hospices Civils de Lyon
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Knee Arthroplasty, Total and Gait Analysis, run by Hospices Civils de Lyon at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Femorotibial mechanical axis (varus, valgus) analysis (time frame: at 6 months postoperatively). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2021.