Total Knee ArthroplastyMAKO CIMENTNCT04692714
Evaluation of Two Surgical Strategies for Robotic Implantation of Total Knee Prostheses (Stryker), Cemented Versus Uncemented
A study testing Knee prosthesis implementation with additional cement and Knee prosthesis implementation without additional cement in people with Total Knee Arthroplasty, run by Hospices Civils de Lyon at 2 sites in France.
Trial summary
Total knee replacement surgery (TKA) is a treatment for advanced tibial-femoral osteoarthritis. This intervention is justified in case of significant discomfort and failure of medical treatment. Read more about this study
- Who is it for?
- Ages 50 to 80 years
- Conditions the study is for
- Total Knee Arthroplasty
- What is being tested?
- Knee prosthesis implementation with additional cement and Knee prosthesis implementation without additional cement
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 2 sitesFrance
- Study dates
- 16 May 2022to 16 Oct 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 50 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of internal, external or global femorotibial knee osteoarthritis
- Indication for first-line total knee arthroplasty
- having given informed consent
- Affiliated with a social security scheme
- Patient being able to understand the objectives of the study and willing to comply with postoperative instructions.
Who cannot join
- Patient with rheumatoid arthritis
- Preoperative flexion less than 90 °
- Prosthesis associated with an osteotomy
- History of surgery on the operated knee, except arthroscopy
- Poor bone quality assessed by the surgeon
- Knee deformation greater than 10 ° preoperatively (HKA)
Show all 10Show fewer
- Pregnant or breastfeeding Women
- 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
- Patient already participating to another clinical trial that might jeopardize the current trial
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
France2 sites, 2 recruiting
- Recruiting
Department of orthopedic surgery, Hopital Nord Croix-Rousse- Hospices Civils de Lyon
Lyon, 69004
Sébastien LUSTIG, Professor, 33 (0) 4 26 10 92 98, sebastien.lustig@chu-lyon.fr
Julien BERTHILLER, 33 (0) 4 72 11 80 67, julien.berthiller@chu-lyon.fr
- Recruiting
Chirurgie Orthopédique et Traumatologique Centre Hospitalier Lyon Sud, Hospices Civils de Lyon
Lyon, 69495
Anthony VISTE, MD, PhD, +33 (0)4 78 86 37 38, anthony.viste@chu-lyon.fr
Anthony VISTE, MD, PhD
About this study
Official title: Evaluation of Two Surgical Strategies for Robotic Implantation of Total Knee Prostheses (Stryker), Cemented Versus Uncemented. Prospective, Randomized, Single-center, Multisite Non-inferiority Study.
Total knee replacement surgery (TKA) is a treatment for advanced tibial-femoral osteoarthritis. This intervention is justified in case of significant discomfort and failure of medical treatment. It aims to replace the native internal and external femoro-tibial joints with a joint between a femoral implant and a tibial implant.
Implants can be cemented or cementless. The longevity of these implants depends among other things on the quality of the bone fixation of the implants. It is therefore essential that this fixation be evaluated. The advantages of an uncemented TKA are the preservation of bone stock, the absence of wear by cement debris and prolonged fixation thanks to osseointegration. These characteristics are all the more interesting in a young population.
Read more
Numerous studies have been carried out on the survival of TKA with and without cement. The results found are not unanimous and mainly concern the survival of the implants and the presence of radiological signs of loosening. In addition, no study has evaluated the results of TKA with or without cement implanted using robotic assistance. The precision provided by the robotic system could improve the results of these uncemented implants.
Very few studies are interested in the functional results according to the cementation or not of TKA. And most of these studies do not have a high level of methodological evidence.
We would like to prospectively evaluate the functional results, survival, as well as the rate of radiological border after TKA with or without cement posed with robotic assistance, in the short and medium term.
- Conditions
- Total Knee Arthroplasty
- Being tested
- Knee prosthesis implementation with additional cement, Knee prosthesis implementation without additional cement
- Keywords
- total knee arthroplasty, prosthesis, cement, MAKO, IKS score
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Knee prosthesis implementation with additional cementDevice
During surgery, a TRIATHLON prosthesis will be implemented with the MAKO robot with additional cement.
Knee prosthesis implementation without additional cementDevice
During surgery, a TRIATHLON prosthesis will be implemented with the MAKO robot without additional cement.
| Study group | Role | What they receive |
|---|---|---|
| Experimental knee prosthesis implantation | Experimental | Patients included in this arm will have a total knee arthroplasty using a Triathlon prosthesis by STRYKER implemented without additional cement using the MAKO robot Receives: Device: Knee prosthesis implementation without additional cement |
| Conventional knee prosthesis implantation | Active comparator | Patients included in this arm will have a total knee arthroplasty using a Triathlon prosthesis by STRYKER implemented with additional cement using the MAKO robot Receives: Device: Knee prosthesis implementation with additional cement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in International Knee Society (IKS) function score at 12 Months
The knee function will be evaluated using the delta of the IKS function score between baseline (before surgery) and 1 year after total knee arthroplasty, and compared between the 2 arms.
Measured: Baseline and 12 months
Secondary outcomes (7)
Change from baseline in IKS objective score at 12 Months
The knee function will be evaluated using the delta of the IKS objective score between baseline (before surgery) and 1 year after total knee arthroplasty, and compared between the 2 arms.
Measured: Baseline and 12 months
Change from baseline in IKS function score at 60 Months
The knee function will be evaluated using the delta of the IKS function score between baseline (before surgery) and 5 years after total knee arthroplasty.
Measured: Baseline and 60 months
Change from baseline in IKS objective score at 60 Months
The knee function will be evaluated using the delta of the IKS objective score between baseline (before surgery) and 5 years after total knee arthroplasty.
Measured: Baseline and 60 months
Forgotten joint score at 12 Months
Patient prosthesis acceptability will be evaluated thanks to the forgotten joint score 12 months after total knee arthroplasty
Measured: 12 months
Forgotten joint score at 60 Months
Patient prosthesis acceptability will be evaluated thanks to the forgotten joint score 60 months after total knee arthroplasty
Measured: 60 months
Presence of progressive radiological border at 12 Months
Progressive radiological border will be judged significant if it is at least 2 mm long at the interface between the implant (or cement) and the bone, or if it progresses in comparison to immediate post-surgical time.
Measured: 12 months
Unsealing free survival at 60 months
Unsealing free survival of knee prosthesis 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 posted5 Jan 2021
- Study start16 May 2022
- Primary completion16 May 2025 (estimated)
- Study completion16 Oct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Total Knee ArthroplastyStudies 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Collaborators
- Stryker Nordic
- Responsible party
- Sponsor
- Investigators
- Sébastien LUSTIG, Professor, Principal investigator, Hospices Civils de Lyon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04692714
- Sponsor's protocol ID
- 69HCL20_0872
- Acronym
- MAKO CIMENT
- Status last verified
- Nov 2024
- First submitted
- 30 Dec 2020
- Last updated
- 3 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Two Surgical Strategies for Robotic Implantation of Total Knee Prostheses (Stryker), Cemented Versus Uncemented. Prospective, Randomized, Single-center, Multisite Non-inferiority Study.
- ClinicalTrials.gov ID
- NCT04692714
- Acronym / sponsor ID
- MAKO CIMENT / 69HCL20_0872
- Conditions
- Total Knee Arthroplasty
- Keywords
- total knee arthroplasty, prosthesis, cement, MAKO, IKS score
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Collaborators
- Stryker Nordic
- Study start
- 16 May 2022 (actual)
- Primary completion
- 16 May 2025 (estimated)
- Study completion
- 16 Oct 2028 (estimated)
- First posted
- 5 Jan 2021 (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 replacement surgery (TKA) is a treatment for advanced tibial-femoral osteoarthritis. This intervention is justified in case of significant discomfort and failure of medical treatment. It aims to replace the native internal and external femoro-tibial joints with a joint between a femoral implant and a tibial implant.
Implants can be cemented or cementless. The longevity of these implants depends among other things on the quality of the bone fixation of the implants. It is therefore essential that this fixation be evaluated. The advantages of an uncemented TKA are the preservation of bone stock, the absence of wear by cement debris and prolonged fixation thanks to osseointegration. These characteristics are all the more interesting in a young population.
Numerous studies have been carried out on the survival of TKA with and without cement. The results found are not unanimous and mainly concern the survival of the implants and the presence of radiological signs of loosening. In addition, no study has evaluated the results of TKA with or without cement implanted using robotic assistance. The precision provided by the robotic system could improve the results of these uncemented implants.
Very few studies are interested in the functional results according to the cementation or not of TKA. And most of these studies do not have a high level of methodological evidence.
We would like to prospectively evaluate the functional results, survival, as well as the rate of radiological border after TKA with or without cement posed with robotic assistance, in the short and medium term.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental knee prosthesis implantation | Experimental | Device: Knee prosthesis implementation without additional cementPatients included in this arm will have a total knee arthroplasty using a Triathlon prosthesis by STRYKER implemented without additional cement using the MAKO robot |
| Conventional knee prosthesis implantation | Active comparator | Device: Knee prosthesis implementation with additional cementPatients included in this arm will have a total knee arthroplasty using a Triathlon prosthesis by STRYKER implemented with additional cement using the MAKO robot |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Diagnosis of internal, external or global femorotibial knee osteoarthritis
- Indication for first-line total knee arthroplasty
- having given informed consent
- Affiliated with a social security scheme
- Patient being able to understand the objectives of the study and willing to comply with postoperative instructions.
Key exclusion criteria (10 listed)
- Patient with rheumatoid arthritis
- Preoperative flexion less than 90 °
- Prosthesis associated with an osteotomy
- History of surgery on the operated knee, except arthroscopy
- Poor bone quality assessed by the surgeon
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 |
|---|---|---|
| Knee prosthesis implementation with additional cementDuring surgery, a TRIATHLON prosthesis will be implemented with the MAKO robot with additional cement. | Device | Conventional knee prosthesis implantation |
| Knee prosthesis implementation without additional cementDuring surgery, a TRIATHLON prosthesis will be implemented with the MAKO robot without additional cement. | Device | Experimental knee prosthesis implantation |
Primary outcome
Change from baseline in International Knee Society (IKS) function score at 12 Months
Time frame: Baseline and 12 months
The knee function will be evaluated using the delta of the IKS function score between baseline (before surgery) and 1 year after total knee arthroplasty, and compared between the 2 arms.
7 secondary outcomes
Change from baseline in IKS objective score at 12 Months
Time frame: Baseline and 12 months
Change from baseline in IKS function score at 60 Months
Time frame: Baseline and 60 months
Change from baseline in IKS objective score at 60 Months
Time frame: Baseline and 60 months
Forgotten joint score at 12 Months
Time frame: 12 months
Forgotten joint score at 60 Months
Time frame: 60 months
Presence of progressive radiological border at 12 Months
Time frame: 12 months
Unsealing free survival at 60 months
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 3 Dec 2024.
- Related InfoLink provided by the sponsor.
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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.
Sébastien LUSTIG, Professor principal investigator
Hospices Civils de Lyon
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Knee prosthesis implementation with additional cement and Knee prosthesis implementation without additional cement in people with Total Knee Arthroplasty, run by Hospices Civils de Lyon at 2 sites 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 5 inclusion and 10 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 3 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 Sébastien LUSTIG, Professor (33 (0) 4 26 10 92 98, 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 from baseline in International Knee Society (IKS) function score at 12 Months (time frame: Baseline and 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 3 Dec 2024.