Comparing Articular Noise and Its Perception Between Two Different Types of Individualized Total Knee Arthroplasty

Sponsor
Clinique Trenel
Study ID
NCT07030049
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Postero-stabilized total knee replacement for knee osteoarthritis — DEVICE
    Total knee arthroplasty in which the osteoarthritic knee is replaced with a postero-stabilized total knee replacement. The postero-stabilized TKA consists of a femoral component with a build-in cam mechanism and a tibial component with a post-mechanism.
  • Cruciate-retaining total knee replacement for knee osteoarthritis — DEVICE
    Total knee arthroplasty in which the osteoarthritic knee is replaced with a cruciate-retaining total knee replacement. The cruciate-retaining TKA consists of a femoral component and a tibial component that leaves the posterior cruciate ligament intact.

Study Details

Knee osteoarthritis is a degenerative joint disorder leading to pain and limited movement. Total knee arthroplasty (TKA) has transformed the treatment of knee osteoarthritis, resulting in long-term outcomes that enhance the quality of life for patients. Some individuals report experiencing noise after undergoing TKA. However, there are few randomized controlled trials that assess postoperative noise following the procedure. Additionally, no research has been conducted on individualized TKA, which involves custom-made prostheses tailored to a patient's knee shape. This study aimed to compare the incidence of noise reported by patients who undergo a primary individualized TKA using either cruciate-retaining or posterior-stabilized designs.

Key Dates

First listed
Jun 19, 2025
Start date
Sep 30, 2025
Status verified
Jun 2025
Primary completion
Sep 30, 2028
Completion
Sep 30, 2028

Study Design

Enrollment
210 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER

Arms

  • Experimental: PS-group
    Individualized PS TKA
  • Active Comparator: CR-group
    Individualized CR TKA

Primary Outcome Measure

Do you hear noise originating from your knee? [ Time Frame: 2 years ]

Central Contacts

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