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

ConditionsOsteoarthritis TKA

Trial statusNot yet recruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18+

SponsorClinique Trenel

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

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.

Treatment groups

210 Participants

are divided into 2 treatment groups

Group A: PS-groupExperimental treatment 1 intervention

Group B: CR-groupActive comparator 1 intervention

Trial outcomes

Primary outcomes

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.

Time frame

2 years

Secondary outcomes

Do you feel noise?

The surgeon will ask the blind participant whether they feel articular noise originating from their knee.

Time frame

1 & 2 years

Is the noise a concern or causing discomfort?

The surgeon will ask the blind participant whether the articular noise originating from their knee is a concern or causing discomfort.

Time frame

1 & 2 years

What kind of noise do you hear of feel?

The surgeon will ask the blind participant what kind articular noise originating from their knee (clunk, crepitus, grinding, clicking, other).

Time frame

1 & 2 years

What part of the knee is involved?

The surgeon will ask the blind participant to identify which part of the knee is involved if they hear articular noise originating from their knee.

Time frame

1 & 2 years

Other outcomes

Forgotten Joint Score (FJS)

Patients will complete the 12-item forgotten joint score questionnaire. Scale: 0 (worst) to 100 (best)

Time frame

1 & 2 years

Western Ontario et McMaster Universities Osteoarthritis Index (WOMAC)

Patients will complete the WOMAC questionnaire (3 domains: pain, stiffness and physical function). Scale: 0 (best) to 96 (worst).

Time frame

1 & 2 years

Range of motion.

Clinical evaluation of knee mobility, using measurements of maximum flexion, flexion contracture (FC) and total range of motion (RoM) pre- and post-operatively.

Time frame

1 & 2 years

Pain assessment using the numeric scale

Pain assessment on a numeric scale from 0 to 10.

Time frame

1 & 2 years

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Clinique Trenel

Lead sponsor

ProSurg

Collaborator

Source ClinicalTrials.gov

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