Status:
RECRUITING
Evaluation of Two Surgical Strategies for Robotic Implantation of Total Knee Prostheses (Stryker), Cemented Versus Uncemented
Lead Sponsor:
Hospices Civils de Lyon
Collaborating Sponsors:
Stryker Nordic
Conditions:
Total Knee Arthroplasty
Eligibility:
All Genders
50-80 years
Phase:
NA
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 ai...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 16 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 16 2028
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT04692714
Start Date
May 16 2022
End Date
October 16 2028
Last Update
December 3 2024
Active Locations (2)
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1
Department of orthopedic surgery, Hopital Nord Croix-Rousse- Hospices Civils de Lyon
Lyon, France, 69004
2
Chirurgie Orthopédique et Traumatologique Centre Hospitalier Lyon Sud, Hospices Civils de Lyon
Lyon, France, 69495