Comparing Articular Noise and Its Perception Between Two Different Types of Total Knee Arthroplasty
NCT ID: NCT06880497
Last Updated: 2025-03-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
170 participants
INTERVENTIONAL
2025-03-31
2028-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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UC TKA
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.
total knee arthroplasty
Replacement of knee articulating surface for patients with end-stage osteoarthritis.
PS TKA
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.
total knee arthroplasty
Replacement of knee articulating surface for patients with end-stage osteoarthritis.
Interventions
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total knee arthroplasty
Replacement of knee articulating surface for patients with end-stage osteoarthritis.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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Elsan
OTHER
Responsible Party
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Central Contacts
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References
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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.
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.
Other Identifiers
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2024-02452-45
Identifier Type: -
Identifier Source: org_study_id
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