Status:
RECRUITING
RSA-RCT: Attune S+ TKA Versus Sigma TKA
Lead Sponsor:
Peter den Hollander
Collaborating Sponsors:
Leiden University Medical Center
Conditions:
Osteoarthritis Arthritis
Joint Disease
Eligibility:
All Genders
21-90 years
Phase:
NA
Brief Summary
The PFC Sigma Knee by DePuy Synthes is an excellent knee replacement with an excellent clinical track record, good survival rates (98% 10 years survival in patients aged \< 55 years) and minimal early...
Eligibility Criteria
Inclusion
- 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
- 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).
Key Trial Info
Start Date :
November 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2026
Estimated Enrollment :
64 Patients enrolled
Trial Details
Trial ID
NCT04037735
Start Date
November 1 2019
End Date
June 1 2026
Last Update
October 30 2023
Active Locations (1)
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1
Haaglanden Medical Center
The Hague, South Holland, Netherlands, 2501CK