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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| UC TKA | Active Comparator | The Score II® is a primary cruciate-sacrificing TKA, with a single-radius femoral component that articulates in an ultra-congruent (UC) mobile-bearing tibial insert. The mobile-bearing tibial insert has high anterior and posterior borders to avoid anterior subluxation of the femoral condyles during knee flexion and a concave articular surface with a radius of curvature that matches that of the femoral component in the sagittal plane to ensure high congruence. The Score II® UC TKA comprises eight sizes and offers the choice of using a cemented or uncemented version. In this study, only the cemented version will be used. |
|
| PS TKA | Active Comparator | The Anatomic® is a primary PS TKA with a fixed-bearing polyethylene insert. The femoral component has a cam design that engages on a tibial post to provide anterior-posterior stability during flexion. The Anatomic® PS TKA comprises nine cemented sizes. In this study, only the cemented version will be used. The Anatomic® PS TKA comprises nine cemented sizes. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| total knee arthroplasty | Procedure | Replacement of knee articulating surface for patients with end-stage osteoarthritis. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | 1 year and 2 years |
| Noise characterisation: Type |
| Measure | Description | Time Frame |
|---|---|---|
| Forgotten joint | Forgotten Joint Score (FJS): worst, 0; best, 100 | 1 and 2 years |
| Patient reported outcome score | Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC): worst, 96; best, 0 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Stéphane Van DRIESSCHE, MD | Contact | +33(0)637675746 | svandri@gmail.com | |
| Aurélia Cassany | Contact | +33(0)638229411 | cassany@elsan.care |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St Marguerite clinic | Recruiting | Auxerre | 89000 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32085760 | Result | 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. | |
| 26762299 | Result | 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. |
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Upon a reasonable request, the authors will consider sharing anonymised data while adhering to French and European laws.
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| ID | Term |
|---|---|
| D019645 | Arthroplasty, Replacement, Knee |
| ID | Term |
|---|---|
| D019643 | Arthroplasty, Replacement |
| D001178 | Arthroplasty |
| D019637 | Orthopedic Procedures |
| D013514 | Surgical Procedures, Operative |
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Prospective, monocentric, comparative, 1:1 randomized, single-blinded study evaluating the prevalence of articular noise following primary TKA using UC versus PS implants.
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Characterisation of the type of noise: Q4: What kind of noise do you hear of feel? (Clunk, crepitus, grinding, clicking, other) |
| 1 and 2 years |
| Noise characterisation: Location | Characterisation of the location of noise: Q5: What part of the knee is involved? (Patella, joint, both, other) | 1 and 2 years |
| 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)? | 1 and 2 years |
| Patient reported outcome score | Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC): worst, 96; best, 0 | 1 and 2 years |
| 1 and 2 years |
| Knee mobility: Maximum flexion | Clinical evaluation of knee mobility, using measurements of maximum flexion: degrees | 3 weeks, 3 months, 1 years and 2 years |
| Knee mobility: flexion contracture | Clinical evaluation of knee mobility, using measurements of flexion contracture (FC): degrees | 3 weeks, 3 months, 1 years and 2 years |
| Knee mobility: Range of motion | Clinical evaluation of knee mobility, using measurements of range of motion (ROM): degrees | 3 weeks, 3 months, 1 years and 2 years |
| Joint pain | Pain assessment using the numeric scale (0 to 10): 0, no pain; 10, excruciating pain. | 3 weeks, 3 months, 1 year and 2 years |
| Patient satisfaction | Patient satisfaction assessed using a 5-point Likert scale (very satisfied, satisfied, neutral, dissatisfied, very dissatisfied). | 1 and 2 years |
| Patient quality of life | Patient QoL using the EQ-5D-5L questionnaire: 0, worst; 1, best. | 1 and 2 years |
| Adverse events | Analysis of adverse events: incidence, severity, and relationship to the medical device. | 0 to 2 years |
| D019651 | Plastic Surgery Procedures |
| D019919 | Prosthesis Implantation |