Articular noise after two different types of total knee replacement
Monocentric, Randomized Study, Comparing Articular Noise and Its Perception Between Two Different Types of Total Knee Arthroplasty
NA · Elsan · NCT06880497
This will test whether people who receive one of two types of total knee replacements notice different amounts or kinds of joint noise.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 170 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Elsan (other) |
| Locations | 1 site (Auxerre) |
| Trial ID | NCT06880497 on ClinicalTrials.gov |
What this trial studies
This interventional study compares patient-reported articular noise after primary total knee arthroplasty using an ultra-congruent (Score 2, Amplitude) versus a posterior-stabilized (Anatomic, Amplitude) prosthesis. Adult patients scheduled for primary TKA at St Marguerite clinic who meet inclusion and exclusion criteria will be enrolled and receive one of the two implants during surgery. The primary outcome is patient-perceived noise (clicking, snapping, cracking, or popping) collected as a patient-reported outcome at defined postoperative time points. The trial excludes revision cases, major coronal deformities, pregnancy, and patients unable to consent or comply with study procedures.
Who should consider this trial
Good fit: Adults undergoing primary total knee arthroplasty who can give informed consent, are affiliated with a social security scheme, and meet the listed anatomical and medical inclusion criteria are ideal candidates.
Not a fit: Patients requiring revision TKA, with prior significant knee surgery on the studied knee, large coronal deformities, pregnancy, or inability to follow study procedures are unlikely to benefit from participation.
Why it matters
Potential benefit: If differences are found, surgeons could choose the implant type that reduces bothersome joint noise and potentially improve patient satisfaction after knee replacement.
How similar studies have performed: Existing literature is mixed: a large study reported an association between noise and early residual symptoms while smaller work found no link to one-year satisfaction, so the question remains unresolved.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Adult patients receiving a primary TKA * Signed informed consent * Patients affiliated to a social security scheme * Patients willing and able to comply with study protocol requirements based on the investigator's judgment. Exclusion Criteria: * History of knee surgery on the concerned/studied knee (except arthroscopic surgery) * Patients presenting coronal deformities \> 20°, varus laxity \> 10° and/or valgus laxity \> 15° * Patients receiving revision TKA * Pregnancy or breast-feeding * Patients with protected status under articles L1121-6, LL121-8 and L1122-2 of the French Public Health Code * Unable to comply with study procedures, based on the investigator's judgment.
Where this trial is running
Auxerre
- St Marguerite clinic — Auxerre, France (RECRUITING)
Study contacts
- Study coordinator: Stéphane Van DRIESSCHE, MD
- Email: svandri@gmail.com
- Phone: +33(0)637675746
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Knee Osteoarthristis, Knee Replacement Arthroplasty, Knee Replacement, Total, Noise, Articular noise, Total Knee Arthroplasty, TKA, Total Knee Replacement