Evaluation of Two Surgical Strategies for Robotic Implantation of Total Knee Prostheses (Stryker), Cemented Versus Uncemented. Prospective, Randomized, Single-center, Multisite Non-inferiority Study.

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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. 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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 50
Maximum Age: 80
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
France
Chirurgie Orthopédique et Traumatologique Centre Hospitalier Lyon Sud, Hospices Civils de Lyon
RECRUITING
Lyon
Department of orthopedic surgery, Hopital Nord Croix-Rousse- Hospices Civils de Lyon
RECRUITING
Lyon
Contact Information
Primary
Sébastien LUSTIG, Professor
sebastien.lustig@chu-lyon.fr
33 (0) 4 26 10 92 98
Backup
Julien BERTHILLER
julien.berthiller@chu-lyon.fr
33 (0) 4 72 11 80 67
Time Frame
Start Date: 2022-05-16
Estimated Completion Date: 2028-10-16
Participants
Target number of participants: 200
Treatments
Experimental: Experimental knee prosthesis implantation
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
Active_comparator: Conventional knee prosthesis implantation
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
Authors
Anthony VISTE, Sébastien LUSTIG
Sponsors
Collaborators: Stryker Nordic
Leads: Hospices Civils de Lyon

This content was sourced from clinicaltrials.gov