Knee Osteoarthristis, Knee Replacement Arthroplasty, Knee Replacement, Total
Conditions
Keywords
Noise, Articular noise, Total Knee Arthroplasty, TKA, Total Knee Replacement, TKR
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).
Interventions
PROCEDUREtotal knee arthroplasty
Replacement of knee articulating surface for patients with end-stage osteoarthritis.
Sponsors
Elsan
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Prevalence of articular noise | 2 years | The primary outcome is the prevalence of patients with articular noise at 2 years, evaluated by the Investigator during the follow-up visit through clinical examination and using the following question (Q1): Q1: Do you hear noise? Never, rarely, sometimes, often, extremely often |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Noise characterisation: impact on quality of life | 1 and 2 years | Characterisation of impact on quality of life: Q6: What is the impact of the noise on your quality of life, on a scale from 0 (none) to 10 (severe)? |
| Patient reported outcome score | 1 and 2 years | Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC): worst, 96; best, 0 |
| Noise characterisation: Discomfort | 1 year and 2 years | Characterisation of discomfort due to noise Q2: Do you feel noise? (Never, rarely, sometimes, often, extremely often) Q3: Is the noise a concern, causing discomfort? (Never, rarely, sometimes, often, extremely often) |
| Noise characterisation: Type | 1 and 2 years | Characterisation of the type of noise: Q4: What kind of noise do you hear of feel? (Clunk, crepitus, grinding, clicking, other) |
| Noise characterisation: Location | 1 and 2 years | Characterisation of the location of noise: Q5: What part of the knee is involved? (Patella, joint, both, other) |
Countries
France
Contacts
CONTACTStéphane Van DRIESSCHE, MD
CONTACTAurélia Cassany
Outcome results
None listed