Knee Arthroplasty, TotalKneeKG SphereNCT04226339
Evaluation of Walking Analysis After a Total Knee Arthroplasty With Kinematic Alignment Versus Mechanical Alignment
A study testing total knee arthroplasty with a kinetic alignment and total knee arthroplasty with a mechanical alignment in people with Knee Arthroplasty, Total, run by Hospices Civils de Lyon at 1 site in France.
Trial summary
Total knee arthroplasty (TKA) is a treatment for advanced femoro-tibial osteoarthritis. This surgery is justified in case of significant discomfort and failure of medical treatment. The functional results of TKA are good with a recovery of 6 months - 1 year. Nevertheless, very few patients forget their prostheses. Read more about this study
- Who is it for?
- Ages 55 to 80 years
- Conditions the study is for
- Knee Arthroplasty, Total
- What is being tested?
- total knee arthroplasty with a kinetic alignment and total knee arthroplasty with a mechanical alignment
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 104 participants
- Where
- 1 siteFrance
- Study dates
- 7 Sep 2020to 7 Mar 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 55 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Both sex
- Adults between 55 and 80 years
- Diagnosis of internal or global disabling femorotibial gonarthrosis Indication of total first knee arthroplasty (unilateral), using a Sphere type prosthesis (Medacta)
- Constitutional deformity in varus between 3 ° and 10 °
- Fulfilling the pass conditions of a KneeKG walking test: Unipodal support possible for 1 minute, run for 5 min at a speed of at least 0.8 km / h
- Affiliated to a social security system
- Patients able to understand and fulfill the requirement of the study
Who cannot join
- TKA bilateral
- TKA to change an Uni-compartmental prosthesis
- History of femoral or tibial fracture
- History of femoral or tibial osteotomy
- Associated gesture at the same time (allograft, osteotomy)
- External femorotibial gonarthrosis
Show all 13Show fewer
- Angle Hip Knee Ankle > 178 °
- Constitutional distortion> 10 °
- Refusal to participate in the study
- Persons deprived of their liberty by a judicial or administrative decision, persons under psychiatric care, persons admitted to a health or social institution for purposes other than research
- Adults subject to a legal protection measure
- breastfeeding or pregnant women
- Patient already participating to another clinical trial that might jeopardize the current trial
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Hôpital de la Croix Rousse
Lyon, 69004
Sebastien Lustig, Pr, 4 26 10 92 98 ext. +33, sebastien.lustig@chu-lyon.fr
About this study
Total knee arthroplasty (TKA) is a treatment for advanced femoro-tibial osteoarthritis. This surgery is justified in case of significant discomfort and failure of medical treatment.
The functional results of TKA are good with a recovery of 6 months - 1 year. Nevertheless, very few patients forget their prostheses. A United Kingdom study assessed patient satisfaction in a cohort of 10,000 patients more than one year after TKA: nearly 20% were not satisfied with their TKA.
Read more
The knee is indeed a complex articulation that works differently in the three space plans. Current knee prostheses are trying to replicate this biomechanics and get as close as possible to the anatomy of a native knee.
Bellemans et al. found in 250 asymptomatic patients 32% of men with a constitutional varus greater than 3 ° and 17% of women. Restoration of normal knee function can also be achieved by restoring a moderate constitutional deformity present preoperatively. The objective of the femorotibial alignment was dogmatically fixed at 180° (mechanical femorotibial alignment). In recent years, some surgical teams have attempted to reproduce the preoperative constitutional deformity in varus or valgus with the prosthesis. This femorotibial alignment is called kinematic alignment. This kinematic alignment has already been studied in several randomized studies and has demonstrated improved functional scores. However, these studies focused on specific TKA, which are posterior cruciate TKA, and the assessment was subjective through functional scores. In addition, these TKA were often made with patient specific instrumentation (PSI). Some studies have evaluated walking kinematics after TKA with kinematic alignment. But it was again TKA retaining the posterior cruciate ligament.
The investigators would like to prospectively evaluate the restoration of the medially stabilized TKA walking kinematics (medial-stable TKA or ball in socket stability) implanted with a kinematic alignment compared to a mechanical alignment.
- Conditions
- Knee Arthroplasty, Total
- Being tested
- total knee arthroplasty with a kinetic alignment, total knee arthroplasty with a mechanical alignment
- Keywords
- total knee arthroplasty, prosthesis, kinetic alignment, mechanical alignment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
total knee arthroplasty with a kinetic alignmentProcedure or surgery
During surgery, a SPHERE prosthesis will replace the knee and the femorotibial alignment.
it will be set to reproduce the preoperative constitutional deformity in varus or valgus as it was measured before surgery
total knee arthroplasty with a mechanical alignmentProcedure or surgery
During surgery, a SPHERE prosthesis will replace the knee and the femorotibial alignment.
It will be set to 180° as defined for a mechanical femorotibial alignment
| Study group | Role | What they receive |
|---|---|---|
| total knee arthroplasty with a kinetic alignment | Experimental | Not described Receives: Procedure: total knee arthroplasty with a kinetic alignment |
| total knee arthroplasty with a mechanical alignment | Active comparator | Not described Receives: Procedure: total knee arthroplasty with a mechanical alignment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of short terms walking speed.
Comparison between the 2 arms, of the walking speed variation between the evaluation before surgery and 1 year after total knee arthroplasty
Measured: 12 months
Secondary outcomes (12)
femorotibial angle in frontal plan
Comparison between the 2 groups of the frontal femorotibial angle measured by the KneeKG system, 12 months after total knee arthroplasty
Measured: 12 months
sagittal femorotibial angle
Comparison between the 2 groups of the sagittal femorotibial angle measured by the KneeKG system, 12 months after total knee arthroplasty
Measured: 12 months
tibia rotation compared to the femur
Comparison between the 2 groups of the tibia rotation angle compared to femur measured by the KneeKG system, 12 months after total knee arthroplasty
Measured: 12 months
maximal knee flexion
Comparison between the 2 groups of the maximal knee flexion measured by the KneeKG system, 12 months after total knee arthroplasty
Measured: 12 months
maximal knee extension
Comparison between the 2 groups of the maximal knee extension measured by the KneeKG system, 12 months after total knee arthroplasty
Measured: 12 months
knee range motion
Comparison between the 2 groups of the knee range motion measured by the KneeKG system, 12 months after total knee arthroplasty
Measured: 12 months
knee functional recovery
Comparison between the 2 groups of the knee functional recovery measured by the International Knee Society (IKS) score 12 months after total knee arthroplasty.
International Knee Society score : range 0 to 200, a higher score means a better outcome
Measured: 12 months
Ability of the patient to forget his prosthesis
Comparison between the 2 groups of the patient ability to forget his knee prosthesis measured by the Forgotten Joint score (FJS) 12 months after total knee arthroplasty.
Forgotten Joint Score : range 0 to 100, a higher score means a better outcome
Measured: 12 months
Complications
Comparison between the 2 groups of the proportion of patient with at least one complication including deep infections, prosthesis impairment, knee fracture, surgical revision) during the 12 months after total knee arthroplasty
Measured: 12 months
knee functional recovery
Comparison between the 2 groups of the knee functional recovery measured by the International Knee Society (IKS) score 60 months after total knee arthroplasty.
International Knee Society score : range 0 to 200, a higher score means a better outcome
Measured: 60 months
Ability of the patient to forget his prosthesis
Comparison between the 2 groups of the patient ability to forget his knee prosthesis measured by the Forgotten Joint score (FJS) score 60 months after total knee arthroplasty.
Forgotten Joint Score : range 0 to 100, a higher score means a better outcome
Measured: 60 months
Complications
Comparison between the 2 groups of the proportion of patient with at least one complication including deep infections, prosthesis impairment, knee fracture, surgical revision) during the 60 months after total knee arthroplasty
Measured: 60 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2020
- Study start7 Sep 2020
- Primary completion7 Mar 2025 (estimated)
- Study completion7 Mar 2029 (estimated)
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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 104 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sebastien Lustig, Pr, Principal investigator, Hospices Civils de Lyon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04226339
- Sponsor's protocol ID
- 69HCL19_0497
- Other IDs
- 2019-A02288-49
- Acronym
- KneeKG Sphere
- Status last verified
- Aug 2022
- First submitted
- 9 Jan 2020
- Last updated
- 23 Aug 2022
- 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 23 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Walking Analysis After a Total Knee Arthroplasty With Kinematic Alignment Versus Mechanical Alignment
- ClinicalTrials.gov ID
- NCT04226339
- Acronym / sponsor ID
- KneeKG Sphere / 69HCL19_0497
- Conditions
- Knee Arthroplasty, Total
- Keywords
- total knee arthroplasty, prosthesis, kinetic alignment, mechanical alignment
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 104 participants (estimated)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 7 Sep 2020 (actual)
- Primary completion
- 7 Mar 2025 (estimated)
- Study completion
- 7 Mar 2029 (estimated)
- First posted
- 13 Jan 2020 (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.
Total knee arthroplasty (TKA) is a treatment for advanced femoro-tibial osteoarthritis. This surgery is justified in case of significant discomfort and failure of medical treatment.
The functional results of TKA are good with a recovery of 6 months - 1 year. Nevertheless, very few patients forget their prostheses. A United Kingdom study assessed patient satisfaction in a cohort of 10,000 patients more than one year after TKA: nearly 20% were not satisfied with their TKA.
The knee is indeed a complex articulation that works differently in the three space plans. Current knee prostheses are trying to replicate this biomechanics and get as close as possible to the anatomy of a native knee.
Bellemans et al. found in 250 asymptomatic patients 32% of men with a constitutional varus greater than 3 ° and 17% of women. Restoration of normal knee function can also be achieved by restoring a moderate constitutional deformity present preoperatively. The objective of the femorotibial alignment was dogmatically fixed at 180° (mechanical femorotibial alignment). In recent years, some surgical teams have attempted to reproduce the preoperative constitutional deformity in varus or valgus with the prosthesis. This femorotibial alignment is called kinematic alignment. This kinematic alignment has already been studied in several randomized studies and has demonstrated improved functional scores. However, these studies focused on specific TKA, which are posterior cruciate TKA, and the assessment was subjective through functional scores. In addition, these TKA were often made with patient specific instrumentation (PSI). Some studies have evaluated walking kinematics after TKA with kinematic alignment. But it was again TKA retaining the posterior cruciate ligament.
The investigators would like to prospectively evaluate the restoration of the medially stabilized TKA walking kinematics (medial-stable TKA or ball in socket stability) implanted with a kinematic alignment compared to a mechanical alignment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| total knee arthroplasty with a kinetic alignment | Experimental | Procedure: total knee arthroplasty with a kinetic alignment |
| total knee arthroplasty with a mechanical alignment | Active comparator | Procedure: total knee arthroplasty with a mechanical alignment |
Who may qualify
- Ages
- 55 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Both sex
- Adults between 55 and 80 years
- Diagnosis of internal or global disabling femorotibial gonarthrosis Indication of total first knee arthroplasty (unilateral), using a Sphere type prosthesis (Medacta)
- Constitutional deformity in varus between 3 ° and 10 °
- Fulfilling the pass conditions of a KneeKG walking test: Unipodal support possible for 1 minute, run for 5 min at a speed of at least 0.8 km / h
Key exclusion criteria (13 listed)
- TKA bilateral
- TKA to change an Uni-compartmental prosthesis
- History of femoral or tibial fracture
- History of femoral or tibial osteotomy
- Associated gesture at the same time (allograft, osteotomy)
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 |
|---|---|---|
| total knee arthroplasty with a kinetic alignmentDuring surgery, a SPHERE prosthesis will replace the knee and the femorotibial alignment. it will be set to reproduce the preoperative constitutional deformity in varus or valgus as it was measured before surgery | Procedure or surgery | total knee arthroplasty with a kinetic alignment |
| total knee arthroplasty with a mechanical alignmentDuring surgery, a SPHERE prosthesis will replace the knee and the femorotibial alignment. It will be set to 180° as defined for a mechanical femorotibial alignment | Procedure or surgery | total knee arthroplasty with a mechanical alignment |
Primary outcome
Change of short terms walking speed.
Time frame: 12 months
Comparison between the 2 arms, of the walking speed variation between the evaluation before surgery and 1 year after total knee arthroplasty
12 secondary outcomes
femorotibial angle in frontal plan
Time frame: 12 months
sagittal femorotibial angle
Time frame: 12 months
tibia rotation compared to the femur
Time frame: 12 months
maximal knee flexion
Time frame: 12 months
maximal knee extension
Time frame: 12 months
knee range motion
Time frame: 12 months
knee functional recovery
Time frame: 12 months
Ability of the patient to forget his prosthesis
Time frame: 12 months
Complications
Time frame: 12 months
knee functional recovery
Time frame: 60 months
Ability of the patient to forget his prosthesis
Time frame: 60 months
Complications
Time frame: 60 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Aug 2022.
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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.
Sebastien 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?
A study testing total knee arthroplasty with a kinetic alignment and total knee arthroplasty with a mechanical alignment in people with Knee Arthroplasty, Total, 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 7 inclusion and 13 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: looking for participants now, as of the sponsor's last update on 23 Aug 2022. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sebastien Lustig, Pr (4 26 10 92 98 ext. +33, sebastien.lustig@chu-lyon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of short terms walking speed. (time frame: 12 months). 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 23 Aug 2022.