Evaluation of Two Surgical Strategies for Robotic Implantation of Total Knee Prostheses (Stryker), Cemented Versus Uncemented
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Knee prosthesis implementation with additional cement, Knee prosthesis implementation without additional cement.
- Who it may be relevant to
- Registry conditions: Total Knee Arthroplasty. Basic parameters: 50 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Evaluation of Two Surgical Strategies for Robotic Implantation of Total Knee Prostheses (Stryker), Cemented Versus Uncemented. Prospective, Randomized, Single-center, Multisite Non-inferiority Study.
Overview
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.
Interventions
- Device Knee prosthesis implementation with additional cement
During surgery, a TRIATHLON prosthesis will be implemented with the MAKO robot with additional cement. - Device Knee prosthesis implementation without additional cement
During surgery, a TRIATHLON prosthesis will be implemented with the MAKO robot without additional cement.
Primary outcome measures
- Change from baseline in International Knee Society (IKS) function score at 12 Months [Time frame: Baseline and 12 months]
Secondary outcome measures (7)
- Change from baseline in IKS objective score at 12 Months [Time frame: Baseline and 12 months]
- Change from baseline in IKS function score at 60 Months [Time frame: Baseline and 60 months]
- Change from baseline in IKS objective score at 60 Months [Time frame: Baseline and 60 months]
- Forgotten joint score at 12 Months [Time frame: 12 months]
- Forgotten joint score at 60 Months [Time frame: 60 months]
- Presence of progressive radiological border at 12 Months [Time frame: 12 months]
- Unsealing free survival at 60 months [Time frame: 60 months]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
France · 2 centers
- Department of orthopedic surgery, Hopital Nord Croix-Rousse- Hospices Civils de Lyon — Lyon
- Chirurgie Orthopédique et Traumatologique Centre Hospitalier Lyon Sud, Hospices Civils de — Lyon
Identifiers
NCT: NCT04692714 · 69HCL20_0872