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

NCT07030049 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 210

Last updated 2025-06-26

No results posted yet for this study

Summary

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.

Conditions

Interventions

DEVICE

Postero-stabilized total knee replacement for knee osteoarthritis

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.

DEVICE

Cruciate-retaining total knee replacement for knee osteoarthritis

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.

Sponsors & Collaborators

  • ProSurg

    collaborator UNKNOWN

  • Clinique Trenel

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-09-30
Primary Completion
2028-09-30
Completion
2028-09-30

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Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07030049 on ClinicalTrials.gov