OsteoarthritisMY KneeNCT01818401
Medico-economic Interest of the Patient Matched Cutting Blocks (Ancillary) MyKnee ® LBS During the Poses of Complete Prosthesis of Knee GMK ®. Multicentric, Prospective, Controlled, Opened, Randomised Study About a Medical Device. (My Knee)
A study testing the prosthesis GMK ® without the ancillary MyKnee ® LBS and Matched patient cutting blocks MyKnee ® LBS in people with Osteoarthritis, run by Nantes University Hospital at 1 site in France.
Trial summary
Over 70.000 total knee arthroplasty (TKA) are performed in France every year, with a 10% yearly increase since the early 1990s. The clinical experience shows a strong rate of success on pain relief and on function. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Osteoarthritis
- What is being tested?
- the prosthesis GMK ® without the ancillary MyKnee ® LBS and Matched patient cutting blocks MyKnee ® LBS
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 95 participants
- Where
- 1 siteFrance
- Study dates
- Mar 2013to 11 Dec 2025
- Phase
- Interventional
- 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
Who may be able to join
- all patients requiring a total knee arthroplasty line: primary or secondary osteoarthritis advanced beyond medical treatment.
Who cannot join
- distorded axes or laxity requiring the establishment of constrained prosthesis
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Medico-economic Interest of the Patient Matched Cutting Blocks (Ancillary) MyKnee ® LBS During the Poses of Complete Prosthesis of Knee GMK ®. Multicentric, Prospective, Controlled, Opened, Randomised Study About a Medical Device.
Over 70.000 total knee arthroplasty (TKA) are performed in France every year, with a 10% yearly increase since the early 1990s. The clinical experience shows a strong rate of success on pain relief and on function. Longevity of the implants has been shown to be determined by the biomechanical design of the prosthesis, and by the implantation technique, especially the correct positioning of the bone cuts during the surgery. To improve the precision of these cuts, the patient matched cutting blocks developed by Medacta allow to adapt the bone cuts to the patient's anatomy, improving the reliability of this procedure. A reduction of the surgery time lengh and bleeding would be other benefits expected with this type of ancillary. The objective of this trial is to study the reliability of patient matched cutting blocks for total knee arthroplasty, by both clinical and radiological assessment, the effect on morbidity reduction during and after the procedure and also the benefit it could bring on an economic point of view.
- Conditions
- Osteoarthritis
- Being tested
- the prosthesis GMK ® without the ancillary MyKnee ® LBS, Matched patient cutting blocks MyKnee ® LBS
- Keywords
- Ancillary tailored, medico-economic study,, total knee replacement, primary or secondary osteoarthritis
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
the prosthesis GMK ® without the ancillary MyKnee ® LBSDevice
Matched patient cutting blocks MyKnee ® LBSDevice
| Study group | Role | What they receive |
|---|---|---|
| Control group | Other | The control group will be constituted of patients with the prosthesis GMK ® without the ancillary MyKnee ® LBS. Receives: Device: the prosthesis GMK ® without the ancillary MyKnee ® LBS |
| Matched patient | Other | The treated group will consist of patients which the GMK ® prosthesis with ancillary ® MyKnee LBS. Receives: Device: Matched patient cutting blocks MyKnee ® LBS |
What is being measured
The primary outcome is the main question the study is designed to answer.
compare the functionality of the knee after installation of a total knee replacement between the 2 groups
The evaluation will use a specific score for total knee arthroplasty: Part of the Knee Society function score (KSS) measured at 1 year after surgery.
Measured: 2 years after
Secondary outcomes (2)
to assess knee function by autoquestionnaire KOOS, the KSS knee score, operative time, procedure bleeding, reliability of the ancillary
Measured: 2 years after
medico-economic evaluation type "Cost minimization"
- Compare the costs of implementing the two strategies (A and B) taking into account the resources consumed (operative time, anesthetic drugs, blood bags ...).
- Determine the least costly therapeutic intervention and medico-economic impact in the current system of financing of hospital expenditure.
Measured: 2 years after
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2013 (estimated)
- Study startMar 2013
- Primary completionDec 2016
- Study completion11 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteoarthritisStudies of the same condition, open and under way.
- More trials run by Nantes University HospitalThe 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 95 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nantes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01818401
- Sponsor's protocol ID
- RC12_0100
- Acronym
- MY Knee
- Status last verified
- Jul 2026
- First submitted
- 21 Mar 2013
- Last updated
- 17 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Medico-economic Interest of the Patient Matched Cutting Blocks (Ancillary) MyKnee ® LBS During the Poses of Complete Prosthesis of Knee GMK ®. Multicentric, Prospective, Controlled, Opened, Randomised Study About a Medical Device.
- ClinicalTrials.gov ID
- NCT01818401
- Acronym / sponsor ID
- MY Knee / RC12_0100
- Conditions
- Osteoarthritis
- Keywords
- Ancillary tailored, medico-economic study,, total knee replacement, primary or secondary osteoarthritis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 95 participants (actual)
- Lead sponsor
- Nantes University HospitalUniversity, hospital or other
- Study start
- Mar 2013 (actual)
- Primary completion
- Dec 2016 (actual)
- Study completion
- 11 Dec 2025 (actual)
- First posted
- 26 Mar 2013 (estimated)
- 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.
Over 70.000 total knee arthroplasty (TKA) are performed in France every year, with a 10% yearly increase since the early 1990s. The clinical experience shows a strong rate of success on pain relief and on function. Longevity of the implants has been shown to be determined by the biomechanical design of the prosthesis, and by the implantation technique, especially the correct positioning of the bone cuts during the surgery. To improve the precision of these cuts, the patient matched cutting blocks developed by Medacta allow to adapt the bone cuts to the patient's anatomy, improving the reliability of this procedure. A reduction of the surgery time lengh and bleeding would be other benefits expected with this type of ancillary. The objective of this trial is to study the reliability of patient matched cutting blocks for total knee arthroplasty, by both clinical and radiological assessment, the effect on morbidity reduction during and after the procedure and also the benefit it could bring on an economic point of view.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | Other | Device: the prosthesis GMK ® without the ancillary MyKnee ® LBSThe control group will be constituted of patients with the prosthesis GMK ® without the ancillary MyKnee ® LBS. |
| Matched patient | Other | Device: Matched patient cutting blocks MyKnee ® LBSThe treated group will consist of patients which the GMK ® prosthesis with ancillary ® MyKnee LBS. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- all patients requiring a total knee arthroplasty line: primary or secondary osteoarthritis advanced beyond medical treatment.
Key exclusion criteria (1 listed)
- distorded axes or laxity requiring the establishment of constrained prosthesis
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 |
|---|---|---|
| the prosthesis GMK ® without the ancillary MyKnee ® LBS | Device | Control group |
| Matched patient cutting blocks MyKnee ® LBS | Device | Matched patient |
Primary outcome
compare the functionality of the knee after installation of a total knee replacement between the 2 groups
Time frame: 2 years after
The evaluation will use a specific score for total knee arthroplasty: Part of the Knee Society function score (KSS) measured at 1 year after surgery.
2 secondary outcomes
to assess knee function by autoquestionnaire KOOS, the KSS knee score, operative time, procedure bleeding, reliability of the ancillary
Time frame: 2 years after
medico-economic evaluation type "Cost minimization"
Time frame: 2 years after
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 17 Jul 2026.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing the prosthesis GMK ® without the ancillary MyKnee ® LBS and Matched patient cutting blocks MyKnee ® LBS in people with Osteoarthritis, run by Nantes University Hospital 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 1 inclusion and 1 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 17 Jul 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?
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?
compare the functionality of the knee after installation of a total knee replacement between the 2 groups (time frame: 2 years after). 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 17 Jul 2026.