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

NCT04692714 | Recruiting

• 1 other identifier: 69HCL20_0872
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Total Knee Arthroplasty

Keywords

total knee arthroplasty; prosthesis; cement; MAKO; IKS score

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Change from baseline in IKS objective score at 12 Months

  Baseline and 12 months

• Change from baseline in IKS function score at 60 Months

  Baseline and 60 months

• Change from baseline in IKS objective score at 60 Months

  Baseline and 60 months

• Forgotten joint score at 12 Months

  12 months

• Forgotten joint score at 60 Months

  60 months

Study Arms (2)

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

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

Device: Knee prosthesis implementation with additional cement

Interventions

Knee prosthesis implementation with additional cement DEVICE

During surgery, a TRIATHLON prosthesis will be implemented with the MAKO robot with additional cement.

Conventional knee prosthesis implantation

Knee prosthesis implementation without additional cement DEVICE

During surgery, a TRIATHLON prosthesis will be implemented with the MAKO robot without additional cement.

Experimental knee prosthesis implantation

Eligibility Criteria

• Age: 50 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Hospices Civils de Lyon: lead
• Stryker Nordic: collaborator

Study Sites (2)

Department of orthopedic surgery, Hopital Nord Croix-Rousse- Hospices Civils de Lyon

Lyon, 69004, France

RECRUITING

Chirurgie Orthopédique et Traumatologique Centre Hospitalier Lyon Sud, Hospices Civils de Lyon

Lyon, 69495, France

RECRUITING

Related Links

• Related Info

Study Officials

• Sébastien LUSTIG, Professor

  Hospices Civils de Lyon

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sébastien LUSTIG, Professor

CONTACT

33 (0) 4 26 10 92 98; sebastien.lustig@chu-lyon.fr

Julien BERTHILLER

CONTACT

33 (0) 4 72 11 80 67; julien.berthiller@chu-lyon.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 30, 2020
• First Posted: January 5, 2021
• Study Start: May 16, 2022
• Primary Completion: May 16, 2025
• Study Completion (Estimated): October 16, 2028
• Last Updated: December 3, 2024

Record last verified: 2024-11

Locations

FR (2)