Knee OsteoarthritisKAORNCT06603103
Prospective Randomized Study Comparing the SpheriKA® (MEDACTA) and Origin® (SYMBIOS) Prostheses During Total Knee Replacement Using the Kinematic Alignment Technique
A study testing SPHERIKA prosthesis and ORIGIN prosthesis in people with Knee Osteoarthritis, run by Clinique du Sport, Bordeaux Mérignac at 1 site in France.
Trial summary
The traditional technique for implanting a total knee prosthesis, known as mechanical alignment, does not aim to preserve the original anatomy and laxity of the knee. Instead, the implants are "systematically" aligned to create a non-naturally straight lower limb. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- SPHERIKA prosthesis and ORIGIN prosthesis
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteFrance
- Study dates
- 3 Oct 2024to 30 Apr 2028
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient with indication for initial total knee replacement
- Patient affiliated to a social security scheme
- Patient informed of the study and formally included (informed consent signed) before the first research examination.
Who cannot join
- Patient with complex osteoarthritis (e.g. bone loss, history of patellar instability)
- Patient with contralateral knee prosthesis
- Patient with symptomatic osteoarthritis (stiffness and/or pain) of a hip or contralateral knee
- Patient with another condition (acquired pathology) of the lower limbs and/or nervous system that may significantly affect gait quality
- Patient deprived of liberty by judicial or administrative decision,
- Patient of legal age under legal protection or unable to express consent.
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
Clinique du Sport
Mérignac, 33000
Charles Rivière, MD, charles.riviere@bari-arthroplasty.com
About this study
The traditional technique for implanting a total knee prosthesis, known as mechanical alignment, does not aim to preserve the original anatomy and laxity of the knee. Instead, the implants are "systematically" aligned to create a non-naturally straight lower limb. Respectively 20% and 50% of patients with a mechanically aligned total knee prosthesis are dissatisfied with the result, and complain of residual symptoms. A newer, more physiological technique for implanting a total knee prosthesis, known as kinematic alignment, aims to recreate the unique native anatomy and laxity of each patient\'s knee. The kinematic alignment technique has been shown to reduce the risk of residual symptoms and thus improve the patient\'s experience of his or her prosthetic knee. As a result of the emergence of the kinematic alignment technique, two manufacturers have developed total knee prosthesis implants specifically for this new insertion technique. A "made-to-measure" total knee prosthesis (ORIGIN® - Symbios, Yverdon-les-Bains, Switzerland) was developed with the aim of reproducing the unique contour of each implanted knee. Another manufacturer opted to develop a generic total knee prosthesis implant (SPHERIKA® - Medacta, Castel San Pietro, Switzerland), but with a design optimized for the kinematic alignment technique. These two models of total knee prosthesis each offer advantages and limitations that need to be assessed. The main aim of this study is therefore to compare the joint perception of these 2 prostheses. It will also look at the clinical and imaging results, the biomechanics of the prosthetic knee during gait, and the muscular strength of knee extension, obtained for these 2 total knee prostheses.
- Conditions
- Knee Osteoarthritis
- Being tested
- SPHERIKA prosthesis, ORIGIN prosthesis
- Keywords
- Total knee arthroplasty, kinematic alignment, joint perception, biomechanics
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SPHERIKA prosthesisProcedure or surgery
total knee arthroplasty with kinematic alignement with SPHERIKA prosthesis
ORIGIN prosthesisProcedure or surgery
total knee arthroplasty with kinematic alignement with ORIGIN prosthesis
| Study group | Role | What they receive |
|---|---|---|
| total knee arthroplasty with kinematic alignment and SPHERIKA prosthesis | Experimental | Not described Receives: Procedure: SPHERIKA prosthesis |
| total knee arthroplasty with kinematic alignment and ORIGIN prosthesis | Experimental | Not described Receives: Procedure: ORIGIN prosthesis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evolution of "forgotten joint score"
This score consists in 12 questions with a Likert scale from 0 to 5. A high score indicates a high degree of forgetfulness of the prosthesis on the part of the patient.
Measured: 2 months before surgery ; 45 days after surgery ; 1 year after surgery ; 2 years after surgery
Secondary outcomes (3)
Frontal alignment of the lower limb
Measured: 2 months before surgery ; 45 days after surgery ; 1 year after surgery ; 2 years after surgery
Walking ability
Evaluation of walking ability : walking speed, cadence, stride length, stride duration
Measured: 2 years after surgery
Evaluation of muscular strength
Measure of :
- Maximum force developed (N)
- Explosivity (time required to develop maximum force, N/s)
- Power (cumulative force developed during the entire acquisition period, W)
Measured: 2 years after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start3 Oct 2024
- Primary completion31 Mar 2028 (estimated)
- Study completion30 Apr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee OsteoarthritisStudies of the same condition, open and under way.
- 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Clinique du Sport, Bordeaux Mérignac
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06603103
- Sponsor's protocol ID
- 2023-21-SBM
- Acronym
- KAOR
- Status last verified
- Mar 2026
- First submitted
- 17 Sep 2024
- Last updated
- 1 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Randomized Study Comparing the SpheriKA® (MEDACTA) and Origin® (SYMBIOS) Prostheses During Total Knee Replacement Using the Kinematic Alignment Technique
- ClinicalTrials.gov ID
- NCT06603103
- Acronym / sponsor ID
- KAOR / 2023-21-SBM
- Conditions
- Knee Osteoarthritis
- Keywords
- Total knee arthroplasty, kinematic alignment, joint perception, biomechanics
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Clinique du Sport, Bordeaux MérignacUniversity, hospital or other
- Study start
- 3 Oct 2024 (actual)
- Primary completion
- 31 Mar 2028 (estimated)
- Study completion
- 30 Apr 2028 (estimated)
- First posted
- 19 Sep 2024 (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 traditional technique for implanting a total knee prosthesis, known as mechanical alignment, does not aim to preserve the original anatomy and laxity of the knee. Instead, the implants are "systematically" aligned to create a non-naturally straight lower limb. Respectively 20% and 50% of patients with a mechanically aligned total knee prosthesis are dissatisfied with the result, and complain of residual symptoms. A newer, more physiological technique for implanting a total knee prosthesis, known as kinematic alignment, aims to recreate the unique native anatomy and laxity of each patient\'s knee. The kinematic alignment technique has been shown to reduce the risk of residual symptoms and thus improve the patient\'s experience of his or her prosthetic knee. As a result of the emergence of the kinematic alignment technique, two manufacturers have developed total knee prosthesis implants specifically for this new insertion technique. A "made-to-measure" total knee prosthesis (ORIGIN® - Symbios, Yverdon-les-Bains, Switzerland) was developed with the aim of reproducing the unique contour of each implanted knee. Another manufacturer opted to develop a generic total knee prosthesis implant (SPHERIKA® - Medacta, Castel San Pietro, Switzerland), but with a design optimized for the kinematic alignment technique. These two models of total knee prosthesis each offer advantages and limitations that need to be assessed. The main aim of this study is therefore to compare the joint perception of these 2 prostheses. It will also look at the clinical and imaging results, the biomechanics of the prosthetic knee during gait, and the muscular strength of knee extension, obtained for these 2 total knee prostheses.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| total knee arthroplasty with kinematic alignment and SPHERIKA prosthesis | Experimental | Procedure: SPHERIKA prosthesis |
| total knee arthroplasty with kinematic alignment and ORIGIN prosthesis | Experimental | Procedure: ORIGIN prosthesis |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patient with indication for initial total knee replacement
- Patient affiliated to a social security scheme
- Patient informed of the study and formally included (informed consent signed) before the first research examination.
Key exclusion criteria (6 listed)
- Patient with complex osteoarthritis (e.g. bone loss, history of patellar instability)
- Patient with contralateral knee prosthesis
- Patient with symptomatic osteoarthritis (stiffness and/or pain) of a hip or contralateral knee
- Patient with another condition (acquired pathology) of the lower limbs and/or nervous system that may significantly affect gait quality
- Patient deprived of liberty by judicial or administrative decision,
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 |
|---|---|---|
| SPHERIKA prosthesistotal knee arthroplasty with kinematic alignement with SPHERIKA prosthesis | Procedure or surgery | total knee arthroplasty with kinematic alignment and SPHERIKA prosthesis |
| ORIGIN prosthesistotal knee arthroplasty with kinematic alignement with ORIGIN prosthesis | Procedure or surgery | total knee arthroplasty with kinematic alignment and ORIGIN prosthesis |
Primary outcome
Evolution of "forgotten joint score"
Time frame: 2 months before surgery ; 45 days after surgery ; 1 year after surgery ; 2 years after surgery
This score consists in 12 questions with a Likert scale from 0 to 5. A high score indicates a high degree of forgetfulness of the prosthesis on the part of the patient.
3 secondary outcomes
Frontal alignment of the lower limb
Time frame: 2 months before surgery ; 45 days after surgery ; 1 year after surgery ; 2 years after surgery
Walking ability
Time frame: 2 years after surgery
Evaluation of muscular strength
Time frame: 2 years after surgery
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 1 Apr 2026.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SPHERIKA prosthesis and ORIGIN prosthesis in people with Knee Osteoarthritis, run by Clinique du Sport, Bordeaux Mérignac 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 3 inclusion and 6 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 1 Apr 2026. 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 Charles Rivière, MD (+335 56 46 32 33, charles.riviere@bari-arthroplasty.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evolution of "forgotten joint score" (time frame: 2 months before surgery ; 45 days after surgery ; 1 year after surgery ; 2 years after surgery). 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 1 Apr 2026.