Comparing Articular Noise and Its Perception Between Two Different Types of Total Knee Arthroplasty
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorElsan
About this trial
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
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
total knee arthroplasty
Procedure/SurgeryReplacement of knee articulating surface for patients with end-stage osteoarthritis.
Treatment groups
170 Participants
are divided into 2 treatment groupsGroup A: UC TKAActive comparator 1 intervention
Group B: PS TKAActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Prevalence of articular noise
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
Time frame
2 yearsSecondary outcomes
1
Noise characterisation: Discomfort
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)
Time frame
1 year and 2 years2
Noise characterisation: Type
Characterisation of the type of noise: Q4: What kind of noise do you hear of feel? (Clunk, crepitus, grinding, clicking, other)
Time frame
1 and 2 years3
Noise characterisation: Location
Characterisation of the location of noise: Q5: What part of the knee is involved? (Patella, joint, both, other)
Time frame
1 and 2 years4
Noise characterisation: impact on quality of life
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)?
Time frame
1 and 2 yearsOther outcomes
1
Forgotten joint
Forgotten Joint Score (FJS): worst, 0; best, 100
Time frame
1 and 2 years2
Patient reported outcome score
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC): worst, 96; best, 0
Time frame
1 and 2 years3
Knee mobility: Maximum flexion
Clinical evaluation of knee mobility, using measurements of maximum flexion: degrees
Time frame
3 weeks, 3 months, 1 years and 2 years4
Knee mobility: flexion contracture
Clinical evaluation of knee mobility, using measurements of flexion contracture (FC): degrees
Time frame
3 weeks, 3 months, 1 years and 2 years Source ClinicalTrials.gov