Status:
COMPLETED
RSA RCT: ATTUNE™ TKA Versus PFC Sigma TKA
Lead Sponsor:
Leiden University Medical Center
Collaborating Sponsors:
Medical Center Haaglanden
DePuy International
Conditions:
Osteoarthritis Arthritis
Joint Diseases
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)(Keenan et al., 20...
Eligibility Criteria
Inclusion
- Patient is diagnosed with osteoarthritis or rheumatoid arthritis and requiring 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
- 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
- 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 :
September 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 2 2017
Estimated Enrollment :
74 Patients enrolled
Trial Details
Trial ID
NCT02256098
Start Date
September 1 2014
End Date
November 2 2017
Last Update
February 1 2018
Active Locations (2)
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1
Leiden University Medical Center
Leiden, Netherlands, 2300RC
2
Medisch Centrum Haaglanden
The Hague, Netherlands, 2501CK