Evaluation of Two Surgical Strategies for Robotic Implantation of Total Knee Prostheses (Stryker), Cemented Versus Uncemented
NCT ID: NCT04692714
Last Updated: 2024-12-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
NA
200 participants
INTERVENTIONAL
2022-05-16
2028-10-16
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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
Knee prosthesis implementation without additional cement
During surgery, a TRIATHLON prosthesis will be implemented with the MAKO robot without additional cement.
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
Knee prosthesis implementation with additional cement
During surgery, a TRIATHLON prosthesis will be implemented with the MAKO robot with additional cement.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Knee prosthesis implementation with additional cement
During surgery, a TRIATHLON prosthesis will be implemented with the MAKO robot with additional cement.
Knee prosthesis implementation without additional cement
During surgery, a TRIATHLON prosthesis will be implemented with the MAKO robot without additional cement.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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
50 Years
80 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Stryker Nordic
INDUSTRY
Hospices Civils de Lyon
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Sébastien LUSTIG, Professor
Role: PRINCIPAL_INVESTIGATOR
Hospices Civils de Lyon
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Department of orthopedic surgery, Hopital Nord Croix-Rousse- Hospices Civils de Lyon
Lyon, , France
Chirurgie Orthopédique et Traumatologique Centre Hospitalier Lyon Sud, Hospices Civils de Lyon
Lyon, , France
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Sébastien LUSTIG, Professor
Role: backup
Anthony VISTE, MD, PhD
Role: backup
Related Links
Access external resources that provide additional context or updates about the study.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
69HCL20_0872
Identifier Type: -
Identifier Source: org_study_id