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

Launched by HOSPICES CIVILS DE LYON · Dec 30, 2020

Keywords

ClinConnect Summary

This clinical trial is studying two different surgical methods for total knee replacement surgery, also known as total knee arthroplasty (TKA). The trial aims to compare the use of cemented implants, which are fixed in place with a special glue, versus uncemented implants that rely on the bone to grow into them for stability. Researchers want to see which method works better in terms of how long the implants last and how well patients can move and function after the surgery, especially when robotic assistance is used during the procedure.

To participate in this trial, patients should have been diagnosed with osteoarthritis of the knee and need a total knee replacement for the first time. They should also be able to understand the study and follow the after-surgery care instructions. However, individuals with certain conditions, like rheumatoid arthritis or significant knee deformities, will not be eligible. Participants can expect to undergo TKA with either type of implant and will be monitored for their recovery and the performance of the implants over time. This study is important because it could help improve knee surgery outcomes for many patients.

Gender

ALL

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