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

NCT06880497 | Recruiting

• 1 other identifier: 2024-02452-45
• Study Type: interventional
• Target: 170
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Knee Osteoarthristis; Knee Replacement Arthroplasty; Knee Replacement, Total

Keywords

Noise; Articular noise; Total Knee Arthroplasty; TKA; Total Knee Replacement; TKR

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (5)

• Noise characterisation: Discomfort

  1 year and 2 years

• Noise characterisation: Type

  1 and 2 years

• Noise characterisation: Location

  1 and 2 years

• Noise characterisation: impact on quality of life

  1 and 2 years

• Patient reported outcome score

  1 and 2 years

Other Outcomes (9)

• Forgotten joint

  1 and 2 years

• Patient reported outcome score

  1 and 2 years

• Knee mobility: Maximum flexion

  3 weeks, 3 months, 1 years and 2 years

Study Arms (2)

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.

Procedure: total knee arthroplasty

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.

Procedure: total knee arthroplasty

Interventions

total knee arthroplasty PROCEDURE

Replacement of knee articulating surface for patients with end-stage osteoarthritis.

Also known as: knee surgery, knee replacement

PS TKA; UC TKA

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult patients receiving a primary TKA
• 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.

You may not qualify if:

• History of knee surgery on the concerned/studied knee (except arthroscopic surgery)
• 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.

Sponsors & Collaborators

• Elsan: lead

Study Sites (1)

St Marguerite clinic

Auxerre, 89000, France

RECRUITING

Related Publications (2)

• 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.

  PMID: 32085760 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.

  PMID: 26762299 RESULT

MeSH Terms

Interventions

Arthroplasty, Replacement, Knee

Intervention Hierarchy (Ancestors)

Arthroplasty, Replacement; Arthroplasty; Orthopedic Procedures; Surgical Procedures, Operative; Plastic Surgery Procedures; Prosthesis Implantation

Central Study Contacts

Stéphane Van DRIESSCHE, MD

CONTACT

+33(0)637675746; svandri@gmail.com

Aurélia Cassany

CONTACT

+33(0)638229411; cassany@elsan.care

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Prospective, monocentric, comparative, 1:1 randomized, single-blinded study evaluating the prevalence of articular noise following primary TKA using UC versus PS implants.

Study Record Dates

• First Submitted: March 4, 2025
• First Posted: March 17, 2025
• Study Start: December 24, 2025
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): December 1, 2028
• Last Updated: March 4, 2026

Record last verified: 2026-03

Locations

FR (1)