Evaluation of Two Surgical Strategies for Robotic Implantation of Total Knee Prostheses (Stryker), Cemented Versus Uncemented (MAKO CIMENT)

Civil Hospices of Lyon

Status: Enrolling

Conditions: Total Knee Arthroplasty

Treatments: Device: Knee prosthesis implementation without additional cement; Device: Knee prosthesis implementation with additional cement

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04692714

69HCL20_0872

Details and patient eligibility

About

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.

Enrollment: 200 estimated patients

Sex: All

Ages: 50 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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.

Exclusion criteria

• 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)
• 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 design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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200 participants in 2 patient groups

Experimental knee prosthesis implantation

Experimental group

Description:

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

Treatment:

Device: Knee prosthesis implementation without additional cement

Conventional knee prosthesis implantation

Active Comparator group

Description:

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

Treatment:

Device: Knee prosthesis implementation with additional cement