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

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

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

Treatments tested in this trial

  • Postero-stabilized total knee replacement for knee osteoarthritis
  • Cruciate-retaining total knee replacement for knee osteoarthritis

Treatment groups

210 Participants
are divided into 2 treatment groups

Locations

This trial has no locations

Sponsors and collaborators

Clinique Trenel

Lead sponsor

ProSurg

Collaborator