Comparing cemented and uncemented methods for knee replacement surgery
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.
Run by Hospices Civils de Lyon · NCT04692714 · Data updated 2026-11-12
This study is testing whether using cemented or uncemented methods for knee replacement surgery works better for patients in terms of how long the implants last and how well they attach to the bone.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 50 Years to 80 Years |
| Sex | All |
| Enrollment | 200 (estimated) |
| Sponsor | Hospices Civils de Lyon Academic / other |
| Locations | 2 sites (Lyon and 1 other locations) |
| Status | Recruiting |
| Started | May 16, 2022 |
| Main results expected | May 16, 2025 |
| Study ends | October 16, 2028 |
| Registry record updated | December 3, 2024 |
| Trial ID | NCT04692714 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates include individuals diagnosed with osteoarthritis of the knee who are indicated for first-line total knee arthroplasty.
✕Probably not a fit
Patients with rheumatoid arthritis, poor bone quality, or significant knee deformities may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This clinical trial evaluates two surgical strategies for total knee arthroplasty (TKA) using robotic implantation, specifically comparing cemented versus uncemented prostheses. The study aims to assess the effectiveness of these methods in terms of implant longevity and bone fixation quality. Participants will undergo knee replacement surgery and will be monitored for outcomes related to implant survival and potential complications. The trial is particularly focused on understanding the benefits of uncemented implants, which may preserve bone stock and reduce wear from cement debris.
Why it matters
Potential benefit: If successful, this study could lead to improved outcomes and longevity of knee implants for patients undergoing total knee replacement.
How similar studies have gone: Previous studies have shown mixed results regarding the survival of cemented versus uncemented TKA, indicating that this area remains an important focus for further investigation.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
-
Department of orthopedic surgery, Hopital Nord Croix-Rousse- Hospices Civils de Lyon
Lyon, France Recruiting -
Chirurgie Orthopédique et Traumatologique Centre Hospitalier Lyon Sud, Hospices Civils de Lyon
Lyon, France Recruiting
Study contacts
- Principal investigator: Sébastien LUSTIG, Professor — Hospices Civils de Lyon
- Study coordinator: Sébastien LUSTIG, Professor
- Email: sebastien.lustig@chu-lyon.fr
- Phone: 33 (0) 4 26 10 92 98
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.