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

NCT07030049 | Not Yet Recruiting

• 2 other identifiers: 25.01072.0004612025-A00647-42
• Study Type: interventional
• Target: 210
• Locations: 0 countries
• Sites: N/A

Brief 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

Osteoarthritis; TKA

Keywords

osteoarthritis; TKA; articular noise

Outcome Measures

Primary Outcomes (1)

• Do you hear noise originating from your knee?

  The surgeon will ask the blind participant whether they hear articular noise originating from their knee two years after TKA.

  2 years

Secondary Outcomes (5)

• Do you feel noise?

  1 & 2 years

• Is the noise a concern or causing discomfort?

  1 & 2 years

• What kind of noise do you hear of feel?

  1 & 2 years

• What part of the knee is involved?

  1 & 2 years

• What is the impact of the noise on your quality of life, on a scale from 0 (none) to 10 (severe)?

  1 & 2 years

Other Outcomes (7)

• Forgotten Joint Score (FJS)

  1 & 2 years

• Western Ontario et McMaster Universities Osteoarthritis Index (WOMAC)

  1 & 2 years

• Range of motion.

  1 & 2 years

Study Arms (2)

PS-group

EXPERIMENTAL

Individualized PS TKA

Device: Postero-stabilized total knee replacement for knee osteoarthritis

CR-group

ACTIVE COMPARATOR

Individualized CR TKA

Device: Cruciate-retaining total knee replacement for knee osteoarthritis

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.

PS-group

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.

CR-group

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 elective primary TKA as a treatment for osteoarthritis
• with an intact and functional posterior cruciate ligament
• with no previous knee surgery, on the ipsi- or contra-lateral knee
• who signed the informed consent and are willing to comply with the protocol requirements based on the investigator's judgment.
• affiliated with a social security scheme
• with an ability to answer questionnaires and to communicate freely in French.

You may not qualify if:

• Patients:
• that underwent previous knee surgery, except arthroscopic surgery, on their ipsilateral knee
• with coronal deformities \>20°
• that are pregnant
• any contraindication mentioned in the instructions for use of the medical devices under investigation
• with protected status under articles L1121-6, LL121-8 and L1122-2 of the French Public Health Code
• with other significant disease or disorder which, in the opinion of the investigating surgeon, may put the participant at risk because of participation in the study, or may influence the result of the study
• who cannot comply with the protocol requirements based on the investigator's judgment.

Sponsors & Collaborators

• Clinique Trenel: lead
• ProSurg: collaborator

MeSH Terms

Conditions

Osteoarthritis

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Central Study Contacts

Johanne Beuvelot Beuvelot, PhD

CONTACT

0033 67623373; johanne.beuvelot@clinique-trenel.com

Study Design

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

Model Details: A randomised controlled single-blinded monocentre trial in a superiority framework with a 1:1 allocation ratio.

Study Record Dates

• First Submitted: June 12, 2025
• First Posted: June 19, 2025
• Study Start: September 30, 2025
• Primary Completion (Estimated): September 30, 2028
• Study Completion (Estimated): September 30, 2028
• Last Updated: June 26, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share