Comparing two types of knee prostheses for osteoarthritis treatment
A Clinical Randomized Controlled RSA Trial Comparing the Cemented Attune (S+ Tibia Tray) Fixed Bearing Cruciate Retaining Knee System With the Cemented PFC Sigma Fixed Bearing Cruciate Retaining Knee System
NA · Medical Center Haaglanden · NCT04037735
This study is testing which of two knee replacements, the Attune S+ or the PFC Sigma, works better for people with osteoarthritis who need knee surgery.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 64 (estimated) |
| Ages | 21 Years to 90 Years |
| Sex | All |
| Sponsor | Medical Center Haaglanden (other) |
| Locations | 1 site (The Hague, South Holland) |
| Trial ID | NCT04037735 on ClinicalTrials.gov |
What this trial studies
This study aims to compare the migration, clinical outcomes, and patient-reported outcomes of two knee prostheses: the Attune S+ and the PFC Sigma, both manufactured by DePuy Synthes. Patients diagnosed with osteoarthritis who require primary knee arthroplasty will be included in the study, ensuring a comprehensive analysis by including all consecutive patients to minimize selection bias. The study will assess the performance of each prosthesis over time, focusing on factors such as stability, range of motion, and overall patient satisfaction.
Who should consider this trial
Good fit: Ideal candidates are patients diagnosed with osteoarthritis who require primary knee arthroplasty and can provide informed consent.
Not a fit: Patients with rheumatoid arthritis or those with specific anatomical issues that complicate knee arthroplasty may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved knee replacement options that enhance patient recovery and quality of life.
How similar studies have performed: Previous studies comparing knee prostheses have shown promising results, indicating that this comparative approach is both relevant and potentially beneficial.
Eligibility criteria
Show full inclusion / exclusion 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).
Where this trial is running
The Hague, South Holland
- Haaglanden Medical Center — The Hague, South Holland, Netherlands (RECRUITING)
Study contacts
- Principal investigator: Peter Hollander, MD — Haaglanden Medical Center
- Study coordinator: Peter Hollander, MD
- Email: P.den.Hollander@haaglandenmc.nl
- Phone: +31 88 979 8087
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Osteoarthritis Arthritis, Joint Disease, Musculoskeletal Disease, Rheumatic Diseases, Comparative Study, Knee Prosthesis, Prosthesis Design, Treatment Outcome