Patients with noninflammatory osteoarthritis requiring a unilateral total knee replacement.
Conditions
Interventions
Treatments are primary total knee arthroplasty of the Journey and Genesis II designs, both from Smith & Nephew company. A total knee arthroplasty is a joint replacement treamtent. It contains a lower
Sponsors
Smith and Nephew
Eligibility
Inclusion criteria
Inclusion criteria: 1. Patient presents with noninflammatory osteoarthritis and requires a unilateral total knee replacement. 2. Patient reports moderate to severe pain in affected knee. 3. Patient is 18 40 to 70 years of age, inclusive. 4. Patient is willing to consent to participate in the study by signing and dating an IRB-approved consent form. 5. Patient plans to be available for follow-up through five years postoperative. 6. Patient is in stable health.
Exclusion criteria
Exclusion criteria: 1. Patient known to have insufficient femoral or tibial bone stock resulting from concomittant conditions. 2. Patient has a BMI >35. 3. Patient’s expected physical activity after surgery is 2 or less on the UCLA activity scale. 4. Patient has had previous hip or knee replacement surgery in the last 6 months. 5. Patient has had major, non-arthroscopic surgery to the study knee. 6. Patient has an active, local infection or systemic infection. 7. Patient has physical, emotional or neurological conditions that would compromise the patient’s compliance with postoperative rehabilitation and follow-up. 8. Patient has grade 3 collateral ligament insufficiency. 9. Patient has knee flexion 20°. 11. Patient has varus or valgus deformity >10°, unless correctable to under 10°. 12. Patient has an immunosuppressive disorder. 13. Patient is pregnant or plans to become pregnant during the course of the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| - Active Flexion of the knee | — |
Secondary
| Measure | Time frame |
|---|---|
| - Intra- and perioperative data (operative time, blood loss) - Knee Society Rating System (KSS) - Patella Scoring System - UCLA score - Satisfaction - Active Flexion standing - Passive flexion lying down | — |
Contacts
Public ContactWilco Jacobs
Sint Maartenskliniek Hengstdal 3
Outcome results
None listed