Osteoarthritis, KneeBIOMAKANCT06158646
Mechanically or Kinematically Aligned Total Knee Prosthesis
A study testing kinematic knee prosthesis and biomechanic knee prosthesis in people with Osteoarthritis, Knee, run by Clinique du Sport, Bordeaux Mérignac at 1 site in France.
Trial summary
The mechanical alignment technique (Mechanical Alignment - MA) of a total knee prosthesis (TKA) was developed with the aim of making the installation of a TKA simple and reproducible, and that the prosthetic biomechanics are acceptable, thus promoting good longevity of implants. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Osteoarthritis, Knee
- What is being tested?
- kinematic knee prosthesis and biomechanic knee prosthesis
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteFrance
- Study dates
- 5 Oct 2023to 30 Sep 2027
- 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 followed as part of a consultation 1 year after TKA placement
- Adult patient
- Patient affiliated to a social security system
- Patient informed of the study and formally included (signing of informed consent) before the first research review
Who cannot join
- Patient with a contralateral knee prosthesis
- Patient with another condition (acquired pathology) of the lower limbs (e.g. severe osteoarthritis of the contralateral knee or hip/ankle) and/or of the nervous system (e.g. Parkinson's) which may significantly affect the quality of walking
- Pregnant patient
- Patient deprived of liberty by judicial or administrative decision,
- Adult patient subject to a legal protection measure 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 Bordeaux Merignac
Mérignac, 33700
Charles Rivière, MD, +33 5 56 46 10 40, charles.riviere@bari-arthroplasty.com
About this study
Official title: Mechanically or Kinematically Aligned Total Knee Prosthesis: Prospective and Comparative Study of Clinical, Stereoradiographic, and Biomechanical Results
The mechanical alignment technique (Mechanical Alignment - MA) of a total knee prosthesis (TKA) was developed with the aim of making the installation of a TKA simple and reproducible, and that the prosthetic biomechanics are acceptable, thus promoting good longevity of implants. This is a technique that does not aim to restore the constitutional anatomy of the knee; bone cuts are systematically made at fixed angles, in the 3 planes of space, in relation to the mechanical axes of the long bones (femur and tibia). This non-personalized implantation technique therefore systematically alters the anatomy, laxity and kinematics of the knee, causing up to 50% of residual symptoms after prosthetic implantation and 20% of dissatisfied patients.
In order to improve the clinical results of TKA, a new, more personalized and physiological technique was developed in 2007, called Kinematic Alignment (KA). This technique aims to restore the pre-arthritic anatomy, unique to each knee. Patients with severe constitutional deformity of the lower limb therefore retain this deformity after kinematic prosthetic replacement. The impact of the alignment technique on the biomechanics of the prosthetic knee remains poorly described. The main objective of this study is therefore to compare knee biomechanics between mechanical TKA and kinematic TKA.
- Conditions
- Osteoarthritis, Knee
- Being tested
- kinematic knee prosthesis, biomechanic knee prosthesis
- Keywords
- total knee prosthesis, mechanical alignment, kinematic alignment, biomechanic study
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
kinematic knee prosthesisDevice
Patients with a kinematically aligned total knee prosthesis and having a post-operative follow-up consultation within at least 1 year after their surgery are consecutively pre-selected according to the eligibility criteria.
biomechanic knee prosthesisDevice
A group of patients with a mechanically aligned TKA and scheduled for a follow-up consultation 1 year after surgery will be identified to be matched on the aforementioned criteria (sex, age, BMI).
| Study group | Role | What they receive |
|---|---|---|
| patients with kinematic aligned knee prosthesis | Experimental | Not described Receives: Device: kinematic knee prosthesis |
| patients with biomechanic aligned knee prosthesis | Active comparator | Not described Receives: Device: biomechanic knee prosthesis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Biomechanical parameters of knee : spatiotemporal parameters
When walking on flat ground and when going up/down stairs:
walking speed
Measured: One year after surgery
Biomechanical parameters of knee : Kinematic parameters in the 3 planes of space
dynamic hip-knee-ankle angles during the knee flexion/extension test with and without support
Measured: One year after surgery
Biomechanical parameters of knee : joint moments
Unit : Newton meter
Measured: One year after surgery
Biomechanical parameters of knee : force
Unit : body weight
Measured: One year after surgery
Biomechanical parameters of knee : lever arms
Measured: One year after surgery
Symmetry index between the operated limb and the healthy controlateral limb
Comparison between the two limbs
Measured: One year after surgery
Secondary outcomes (12)
Clinical results : Patient-Reported Outcome Measures: Functional score (OXFORD scale)
OXFORD scale : numerical rating scale used to quantify the power or strength produced by the contraction of a muscle (0-5) ; 5 is maximal strenght
Measured: One year after surgery
Clinical results : Patient-Reported Outcome Measures: joint perception score
Forgotten joint score : joint-specific questionnaire that focuses on the patients' awareness of their prosthetic joint during daily activities ; 0-100 (0 is the worst result and 100 the better result possible)
Measured: One year after surgery
Clinical results : Patient-Reported Outcome Measures: pain
visual analog scale (VAS) pain (numerical scale 0-10), 0 is absence of pain and 10 the worst pain possible
Measured: One year after surgery
Clinical results : Patient satisfaction
Scale from "not at all satisfied" to "very satisfied"
Measured: One year after surgery
Clinical results : range of mobility of the prosthetic knee
Range of motion from hyperextension to flexion (degrees)
Measured: One year after surgery
Clinical results : complication rate
Complication rate (percentage) : manipulation under anesthesia, re-operation, revision, previous pain syndrome
Measured: One year after surgery
Imaging results : EOS 3D, alignement of the lower limb
measurement of the frontal alignment of the lower limb (hip-knee-ankle and hip-knee-calcaneus angles)
Measured: One year after surgery
Imaging results : EOS 3D, orientation of the implants
- measurement of the orientation of the implants in the frontal (medial proximal tibial, lateral distal femoral and joint line convergence angles) and sagittal (tibial slope, flexion of the femoral component) planes
Measured: One year after surgery
Imaging results : EOS 3D, distance between anterior femoral cortex and prosthetic trochlea
measurement of the distance between the anterior femoral cortex and the prosthetic trochlea
Measured: One year after surgery
Imaging results : radiography, evaluation of implant fixation
evaluation of implant fixation (e.g. sealing, border, reactive line)
Measured: One year after surgery
Imaging results : radiography, measurement of patellar height
measurement of patellar height (pre- and post-op Caton-Deschamps index comparison)
Measured: One year after surgery
Imaging results : radiography, evaluation of the bone structure
evaluation of bone structure (e.g. osteolysis)
Measured: One year after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2023
- Study start5 Oct 2023
- Primary completion31 Aug 2027 (estimated)
- Study completion30 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoarthritis, KneeStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- 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
- NCT06158646
- Sponsor's protocol ID
- 2023-A01312-43
- Acronym
- BIOMAKA
- Status last verified
- Mar 2026
- First submitted
- 14 Nov 2023
- Last updated
- 6 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 6 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mechanically or Kinematically Aligned Total Knee Prosthesis: Prospective and Comparative Study of Clinical, Stereoradiographic, and Biomechanical Results
- ClinicalTrials.gov ID
- NCT06158646
- Acronym / sponsor ID
- BIOMAKA / 2023-A01312-43
- Conditions
- Osteoarthritis, Knee
- Keywords
- total knee prosthesis, mechanical alignment, kinematic alignment, biomechanic study
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Clinique du Sport, Bordeaux MérignacUniversity, hospital or other
- Study start
- 5 Oct 2023 (actual)
- Primary completion
- 31 Aug 2027 (estimated)
- Study completion
- 30 Sep 2027 (estimated)
- First posted
- 6 Dec 2023 (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 mechanical alignment technique (Mechanical Alignment - MA) of a total knee prosthesis (TKA) was developed with the aim of making the installation of a TKA simple and reproducible, and that the prosthetic biomechanics are acceptable, thus promoting good longevity of implants. This is a technique that does not aim to restore the constitutional anatomy of the knee; bone cuts are systematically made at fixed angles, in the 3 planes of space, in relation to the mechanical axes of the long bones (femur and tibia). This non-personalized implantation technique therefore systematically alters the anatomy, laxity and kinematics of the knee, causing up to 50% of residual symptoms after prosthetic implantation and 20% of dissatisfied patients.
In order to improve the clinical results of TKA, a new, more personalized and physiological technique was developed in 2007, called Kinematic Alignment (KA). This technique aims to restore the pre-arthritic anatomy, unique to each knee. Patients with severe constitutional deformity of the lower limb therefore retain this deformity after kinematic prosthetic replacement. The impact of the alignment technique on the biomechanics of the prosthetic knee remains poorly described. The main objective of this study is therefore to compare knee biomechanics between mechanical TKA and kinematic TKA.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| patients with kinematic aligned knee prosthesis | Experimental | Device: kinematic knee prosthesis |
| patients with biomechanic aligned knee prosthesis | Active comparator | Device: biomechanic knee prosthesis |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patient followed as part of a consultation 1 year after TKA placement
- Adult patient
- Patient affiliated to a social security system
- Patient informed of the study and formally included (signing of informed consent) before the first research review
Key exclusion criteria (5 listed)
- Patient with a contralateral knee prosthesis
- Patient with another condition (acquired pathology) of the lower limbs (e.g. severe osteoarthritis of the contralateral knee or hip/ankle) and/or of the nervous system (e.g. Parkinson's) which may significantly affect the quality of walking
- Pregnant patient
- Patient deprived of liberty by judicial or administrative decision,
- Adult patient subject to a legal protection measure or unable to express consent
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 |
|---|---|---|
| kinematic knee prosthesisPatients with a kinematically aligned total knee prosthesis and having a post-operative follow-up consultation within at least 1 year after their surgery are consecutively pre-selected according to the eligibility criteria. | Device | patients with kinematic aligned knee prosthesis |
| biomechanic knee prosthesisA group of patients with a mechanically aligned TKA and scheduled for a follow-up consultation 1 year after surgery will be identified to be matched on the aforementioned criteria (sex, age, BMI). | Device | patients with biomechanic aligned knee prosthesis |
Primary outcome
Biomechanical parameters of knee : spatiotemporal parameters
Time frame: One year after surgery
When walking on flat ground and when going up/down stairs: walking speed
Biomechanical parameters of knee : Kinematic parameters in the 3 planes of space
Time frame: One year after surgery
dynamic hip-knee-ankle angles during the knee flexion/extension test with and without support
Biomechanical parameters of knee : joint moments
Time frame: One year after surgery
Unit : Newton meter
Biomechanical parameters of knee : force
Time frame: One year after surgery
Unit : body weight
Biomechanical parameters of knee : lever arms
Time frame: One year after surgery
Symmetry index between the operated limb and the healthy controlateral limb
Time frame: One year after surgery
Comparison between the two limbs
12 secondary outcomes
Clinical results : Patient-Reported Outcome Measures: Functional score (OXFORD scale)
Time frame: One year after surgery
Clinical results : Patient-Reported Outcome Measures: joint perception score
Time frame: One year after surgery
Clinical results : Patient-Reported Outcome Measures: pain
Time frame: One year after surgery
Clinical results : Patient satisfaction
Time frame: One year after surgery
Clinical results : range of mobility of the prosthetic knee
Time frame: One year after surgery
Clinical results : complication rate
Time frame: One year after surgery
Imaging results : EOS 3D, alignement of the lower limb
Time frame: One year after surgery
Imaging results : EOS 3D, orientation of the implants
Time frame: One year after surgery
Imaging results : EOS 3D, distance between anterior femoral cortex and prosthetic trochlea
Time frame: One year after surgery
Imaging results : radiography, evaluation of implant fixation
Time frame: One year after surgery
Imaging results : radiography, measurement of patellar height
Time frame: One year after surgery
Imaging results : radiography, evaluation of the bone structure
Time frame: One year 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 6 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 kinematic knee prosthesis and biomechanic knee prosthesis in people with Osteoarthritis, Knee, 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 4 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: looking for participants now, as of the sponsor's last update on 6 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 (+33 5 56 46 10 40, 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?
Biomechanical parameters of knee : spatiotemporal parameters (time frame: One year after surgery). The study lists 6 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 6 Apr 2026.