RSA-RCT: Attune S+ TKA Versus Sigma TKA

Launched by PETER DEN HOLLANDER · Jul 26, 2019

Keywords

ClinConnect Summary

This clinical trial is comparing two types of knee replacement implants—the Attune Knee and the PFC Sigma Knee. Both of these devices are made by DePuy Synthes and are used to help people with knee osteoarthritis, a condition that causes pain and stiffness in the joint. The main goal of the study is to see which knee implant migrates less over time and to evaluate how well each implant works based on patient experiences and medical assessments. The trial will include a total of 64 patients who need knee replacement surgery and are capable of giving their consent to participate.

To be eligible for the study, patients must have knee osteoarthritis and require a knee replacement. They should be able to understand the study and agree to join. Participants can expect to have their knee function and recovery tracked through questionnaires and imaging tests over the course of the study. This research aims to provide valuable information to help improve knee replacement options for future patients.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Patient is diagnosed with osteoarthritis and requires primary knee arthroplasty
• • All consecutive patients ("usual care") are included to prevent selection bias in the migration analysis.
• • Patient is capable of giving informed consent and expressing a willingness to comply with this study
• Exclusion Criteria:
• • The patient has an a-priori risk for a posterior-stabilized total knee arthroplasty.
• • Insufficiency of the posterior cruciate ligament (PCL)
• • Status after patellectomy
• • In case flexion is less than 90 degrees
• • The patient is diagnosed with Rheumatoid Arthritis
• • When it is expected that the tibia cut during surgery will compromise the attachment of the PCL (because of bony defects)
• • The patient is unable or unwilling to sign the Informed Consent specific to this study
• • The patient does not understand the Dutch or English language good enough to participate
• • Patients indicated for revision arthroplasty instruments because of bone defects or deformity of the bone
• • When there are not enough markers visible in the baseline RSA photograph and it will not improve by placing the patient in another position, the patient will be excluded from the study (secondary exclusion criteria).