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

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.

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 Overview

• Status: Recruiting
• Conditions: Total Knee Arthroplasty
• Intervention / Treatment: Device: Knee prosthesis implementation without additional cement; Device: Knee prosthesis implementation with additional cement

• Study Type: Interventional
• Enrollment (Estimated): 200
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Sébastien LUSTIG, Professor; Phone Number: 33 (0) 4 26 10 92 98; Email: sebastien.lustig@chu-lyon.fr
• Study Contact Backup: Name: Julien BERTHILLER; Phone Number: 33 (0) 4 72 11 80 67; Email: julien.berthiller@chu-lyon.fr

Study Locations

• France
  • Lyon, France, 69004
    • Recruiting
    • Department of orthopedic surgery, Hopital Nord Croix-Rousse- Hospices Civils de Lyon
    • Contact: Sébastien LUSTIG, Professor; Phone Number: 33 (0) 4 26 10 92 98; Email: sebastien.lustig@chu-lyon.fr
    • Contact: Julien BERTHILLER; Phone Number: 33 (0) 4 72 11 80 67; Email: julien.berthiller@chu-lyon.fr
    • Contact: Sébastien LUSTIG, Professor
  • Lyon, France, 69495
    • Recruiting
    • Chirurgie Orthopédique et Traumatologique Centre Hospitalier Lyon Sud, Hospices Civils de Lyon
    • Contact: Anthony VISTE, MD, PhD; Phone Number: +33 (0)4 78 86 37 38; Email: anthony.viste@chu-lyon.fr
    • Contact: Anthony VISTE, MD, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 46 years to 76 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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	Device: Knee prosthesis implementation without additional cement; During surgery, a TRIATHLON prosthesis will be implemented with the MAKO robot without additional cement.
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	Device: Knee prosthesis implementation with additional cement; During surgery, a TRIATHLON prosthesis will be implemented with the MAKO robot with additional cement.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline and 12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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	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	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.	12 months
Unsealing free survival at 60 months	Unsealing free survival of knee prosthesis 60 months after total knee arthroplasty	60 months

Collaborators and Investigators

• Sponsor: Hospices Civils de Lyon
• Collaborators: Stryker Nordic
• Investigators: Principal Investigator: Sébastien LUSTIG, Professor, Hospices Civils de Lyon

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start (Actual): May 16, 2022
• Primary Completion (Estimated): May 16, 2025
• Study Completion (Estimated): October 16, 2028

Study Registration Dates

• First Submitted: December 30, 2020
• First Submitted That Met QC Criteria: December 30, 2020
• First Posted (Actual): January 5, 2021

Study Record Updates

• Last Update Posted (Actual): December 3, 2024
• Last Update Submitted That Met QC Criteria: November 28, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Keywords: total knee arthroplasty; prosthesis; cement; MAKO; IKS score
• Other Study ID Numbers: 69HCL20_0872

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No