Clinical trial Recruiting at 1 site Interventional Ages 18 and up

Articular noise after two different types of total knee replacement

Official title: Monocentric, Randomized Study, Comparing Articular Noise and Its Perception Between Two Different Types of Total Knee Arthroplasty

Run by Elsan · NCT06880497 · Data updated 2026-11-12

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

Study typeInterventional
Ages18 Years and up
SexAll
Enrollment170 (estimated)
SponsorElsan
Academic / other
Locations1 site (Auxerre)
StatusRecruiting
StartedDecember 24, 2025
Main results expectedDecember 2028
Study endsDecember 2028
Registry record updatedMarch 4, 2026
Trial IDNCT06880497 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a 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.

Probably 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.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

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 gone: 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.

Who can join: the full rules

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 it's running

  • St Marguerite clinic
    Auxerre, France
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.