Clinical trial NCT06880497: Comparing Articular Noise and Its Perception Between Two Different Types of Total Knee Arthroplasty
Official title: Monocentric, Randomized Study, Comparing Articular Noise and Its Perception Between Two Different Types of Total Knee Arthroplasty
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Knee Osteoarthristis
Knee Replacement Arthroplasty
Knee Replacement, Total
Keywords: Noise
Articular noise
Total Knee Arthroplasty
TKA
Total Knee Replacement
TKR
Lead sponsor: Elsan
Sponsor class: OTHER
First posted: 2025-03-17
Enrollment: 170
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Prospective, monocentric, comparative, 1:1 randomized, single-blinded study evaluating the prevalence of articular noise following primary TKA using UC versus PS implants.
Primary purpose: TREATMENT

Brief summary: Some patients complain of articular noise (such as clicking, snapping, cracking or popping) after a total knee replacement. Controversy remains about whether there is a correlation between articular noise and worse outcomes following a knee replacement. A study by Nam et al. on 1540 patients revealed an association between noise and residual symptoms 30 days after they received a total knee replacement. Conversely, a study by Kuriyama et al. on 60 patients revealed no correlation between noise and patient satisfaction after 1 year of receiving a total knee replacement. The incidence of noise following a knee replacement has rarely been studied as a primary outcome. Like pain, it could be considered an important patient-reported outcome to assess patient satisfaction. The study aims to compare the prevalence of patient-perceived noise of an ultra-congruent total knee prosthesis (Score 2, Amplitude) versus a posterior-stabilized total knee prosthesis (Anatomic, Amplitude).


Eligibility 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.

Primary outcomes:
measure: Prevalence of articular noise
timeFrame: 2 years
Secondary outcomes:
measure: Noise characterisation: Discomfort
timeFrame: 1 year and 2 years
measure: Noise characterisation: Type
timeFrame: 1 and 2 years
measure: Noise characterisation: Location
timeFrame: 1 and 2 years
measure: Noise characterisation: impact on quality of life
timeFrame: 1 and 2 years
measure: Patient reported outcome score
timeFrame: 1 and 2 years
Other outcomes:
measure: Forgotten joint
timeFrame: 1 and 2 years
measure: Patient reported outcome score
timeFrame: 1 and 2 years
measure: Knee mobility: Maximum flexion
timeFrame: 3 weeks, 3 months, 1 years and 2 years
measure: Knee mobility: flexion contracture
timeFrame: 3 weeks, 3 months, 1 years and 2 years
measure: Knee mobility: Range of motion
timeFrame: 3 weeks, 3 months, 1 years and 2 years
measure: Joint pain
timeFrame: 3 weeks, 3 months, 1 year and 2 years
measure: Patient satisfaction
timeFrame: 1 and 2 years
measure: Patient quality of life
timeFrame: 1 and 2 years
measure: Adverse events
timeFrame: 0 to 2 years
Locations:
Study officials:
References:
citation: Taniguchi H, Itoh M, Yoshimoto N, Itou J, Kuwashima U, Okazaki K. Noise after total knee arthroplasty has limited effect on joint awareness and patient-reported clinical outcomes: retrospective study. BMC Musculoskelet Disord. 2020 Feb 21;21(1):115. doi: 10.1186/s12891-020-3134-7.
citation: Nam D, Barrack T, Nunley RM, Barrack RL. What Is the Frequency of Noise Generation in Modern Knee Arthroplasty and Is It Associated With Residual Symptoms? Clin Orthop Relat Res. 2017 Jan;475(1):83-90. doi: 10.1007/s11999-016-4701-y.