Actively Recruiting
RSA-RCT: Attune S+ TKA Versus Sigma TKA
Led by Peter den Hollander · Updated on 2023-10-30
64
Participants Needed
1
Research Sites
343 weeks
Total Duration
On this page
Sponsors
P
Peter den Hollander
Lead Sponsor
L
Leiden University Medical Center
Collaborating Sponsor
AI-Summary
What this Trial Is About
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 migration as measured with RSA (0.5mm MTPM at two years follow-up). The Attune Knee by DePuy Synthes is an advancement in knee replacement options. It is designed to provide better range of motion and address the unstable feeling some patients experience during everyday activities, such as stair descent and bending. To date, more than 470,000 patients have received an Attune Knee and positive feedback was received regarding patient recovery, stability and motion. The objective of this study is to accurately assess and compare migration, clinical and radiological outcome and patient reported outcomes of two knee prostheses: the Cemented Attune Fixed Bearing Cruciate Retaining Knee System and the Cemented PFC Sigma Fixed Bearing Cruciate Retaining Knee System, both by DePuy Synthes, Warsaw, Indiana, USA. The primary objective of this study is to compare the magnitude and pattern of migration of the prostheses (Femoral and Tibial component). The secondary objective of this study is to compare clinical and radiological outcome of the prostheses and PROMS. This study is designed as a single-blind, randomized trial between the Attune Knee System and PFC Sigma Knee System. 32 patients with the Attune Knee System and 32 patients with PFC Sigma Knee System will be included in this study. The study population will consist of patients with symptomatic osteoarthritis of the knee scheduled for knee replacement surgery at the Department of Orthopaedics, Haags Medisch Centrum The Hague (HMC), The Netherlands. Annually 350 TKA procedures are performed in this department, of which about 90% is Osteo Arthritis (OA) and 10% Rheumatoid Arthritis (RA) and other indications. We anticipate that inclusion can be accomplished within a 1 year period and that the total study duration is 3 years. Main study parameters/endpoints are: * Migration, measured by means of RSA. * Patient Reported Outcome Measures by means of questionnaires.
CONDITIONS
Official Title
RSA-RCT: Attune S+ TKA Versus Sigma TKA
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosed with osteoarthritis requiring primary knee arthroplasty
- All consecutive patients are included to avoid selection bias
- Capable of giving informed consent and willing to comply with the study
You will not qualify if you...
- Risk for posterior-stabilized total knee arthroplasty due to:
- Posterior cruciate ligament insufficiency
- Previous patellectomy
- Knee flexion less than 90 degrees
- Diagnosis of Rheumatoid Arthritis
- Expected tibia cut compromising posterior cruciate ligament attachment
- Unable or unwilling to sign informed consent
- Insufficient understanding of Dutch or English
- Indicated for revision arthroplasty due to bone defects or deformity
- Inadequate markers visible on baseline RSA photograph preventing analysis
AI-Screening
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Trial Site Locations
Total: 1 location
1
Haaglanden Medical Center
The Hague, South Holland, Netherlands, 2501CK
Actively Recruiting
Research Team
P
Peter Hollander, MD
CONTACT
B
Bart K Kaptein, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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