Comparing Articular Noise and Its Perception Between Two Different Types of Total Knee Arthroplasty
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: total knee arthroplasty.
- Who it may be relevant to
- Registry conditions: Knee Osteoarthristis, Knee Replacement Arthroplasty, Knee Replacement, Total. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Monocentric, Randomized Study, Comparing Articular Noise and Its Perception Between Two Different Types of Total Knee Arthroplasty
Overview
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).
Interventions
- Procedure total knee arthroplasty
Replacement of knee articulating surface for patients with end-stage osteoarthritis.
Primary outcome measures
- Prevalence of articular noise [Time frame: 2 years]
Secondary outcome measures (5)
- Noise characterisation: Discomfort [Time frame: 1 year and 2 years]
- Noise characterisation: Type [Time frame: 1 and 2 years]
- Noise characterisation: Location [Time frame: 1 and 2 years]
- Noise characterisation: impact on quality of life [Time frame: 1 and 2 years]
- Patient reported outcome score [Time frame: 1 and 2 years]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
France · 1 center
- St Marguerite clinic — Auxerre
Publications
- 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. PMID 32085760
- 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. PMID 26762299
Identifiers
NCT: NCT06880497 · 2024-02452-45