NCT07030049

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

Monocentric, Randomized Study, Comparing Articular Noise and Its Perception Between Two Different Types of Individualized Total Knee Arthroplasty

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 210 (estimated)
• Sponsor: Clinique Trenel · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Articular noise is common after total knee arthroplasty (TKA), yet there is ongoing debate regarding its effect on postoperative outcomes, joint awareness and patient satisfaction. A comparative study on articular noise in 50 patients undergoing bilateral TKA using two different prosthesis designs reported that an ultra-congruent design generated less noise than a posterior-stabilized design (18% compared with 38%; p= 0.026), but there were no differences in patient preference, satisfaction, or Forgotten Joint Score (FJS) at two-year follow-up. A retrospective analysis of 160 robot-assisted and 320 conventional TKA revealed no difference in the prevalence of articular noise (40.7% vs 38.1%; p=0.647), but patients who complained of noise had lower FJS (45.5 vs 66.1; p\<0.001) and lower Knee Injury and Osteoarthritis Score Joint Replacement (KOOS-JR) scores (72.0 vs 81.4; p\<0.001) at one-year follow-up. Recent advancements have shifted medicine from standardised approaches to personalised or precision medicine, tailoring treatments and decisions for individual patients based on their specific responses and risk factors. Individualized TKA adapts features to align with pre-arthritic anatomy and restore native movement, often utilising various tools. Recent studies on individualized TKA have demonstrated promising outcomes regarding personalised coronal alignment targets, correction of extra-articular deformities, intra-operative workflow, accommodation of the third compartment, and patient satisfaction rates. This study will compare a posterior-stabilised (PS) and a cruciate-retaining (CR) individualized TKA implant. The PS implant is selected for patients with a damaged or a non-functional posterior cruciate ligament. In this case, the ligament is removed and substituted with a post-cam mechanism that aids femoral rollback during knee flexion and avoids anterior femoral subluxation. In contrast, the CR implant design can be selected for patients with an intact and functional posterior cruciate ligament. In this case, the ligament is retained, allowing it to guide femoral rollback and prevent anterior subluxation.

Conditions

• Osteoarthritis
• TKA

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2025-09-30
• Primary completion: 2028-09-30
• Completion: 2028-09-30
• First posted: 2025-06-19
• Last updated: 2025-06-26