Knee prosthesis implementation with additional cement
DeviceDuring surgery, a TRIATHLON prosthesis will be implemented with the MAKO robot with additional cement.
NCT Number: NCT04692714
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.
Interested in participating?
Request Info50 year–80 year
All sexes
Interventional
Not applicable
Chirurgie Orthopédique et Traumatologique Centre Hospitalier Lyon Sud, Hospices Civils de Lyon, Lyon, France
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
During surgery, a TRIATHLON prosthesis will be implemented with the MAKO robot with additional cement.
During surgery, a TRIATHLON prosthesis will be implemented with the MAKO robot without additional cement.
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.
Time frame: Baseline and 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.
Time frame: Baseline and 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.
Time frame: Baseline and 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.
Time frame: 12 months
Patient prosthesis acceptability will be evaluated thanks to the forgotten joint score 12 months after total knee arthroplasty
Time frame: 60 months
Patient prosthesis acceptability will be evaluated thanks to the forgotten joint score 60 months after total knee arthroplasty
Time frame: 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.
Time frame: 60 months
Unsealing free survival of knee prosthesis 60 months after total knee arthroplasty
Contact information is provided by the study sponsor or research team.
Julien BERTHILLER
CONTACT
Sébastien LUSTIG, Professor
CONTACT
Hospices Civils de Lyon
Other
Evaluation of Two Surgical Strategies for Robotic Implantation of Total Knee Prostheses (Stryker), Cemented Versus Uncemented. Prospective, Randomized, Single-center, Multisite Non-inferiority Study.
Acronym: MAKO CIMENT
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