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
Locations
Sponsors and collaborators
Clinique Trenel
Lead sponsor
ProSurg
Collaborator