Flexion with the Journey II BCS Total Knee System. A Prospective, Non-randomized, Consecutive Series, Observational Study.

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 62

Inclusion Criteria

• Patient presents with non-inflammatory knee osteoarthritis (radiologically confirmed), requiring total knee arthroplasty
• Patient is 40 to 70 years of age, inclusive
• Patient plans to be available for follow-up through two years postoperative
• Patient is in stable health and is free of or treated for cardiac, pulmonary, haematological, or other conditions that would pose excessive operative risk
• Patient has <10 degrees fixed (non-correctable) varus or valgus deformity
• Orthopaedic surgeon is member of the Knee Reconstruction Unit SMK

Exclusion Criteria

• Patient is known to have insufficient femoral or tibial bone stock
• Patient has a BMI >35
• Patient*s expected physical activity after surgery is 2 or less on the UCLA Activity Scale
• Patient has had previous hip or knee replacement surgery in the last 6 months
• Patient is planned to have additional hip or contralateral knee replacement in the next 6 months
• Patient has had major, non-arthroscopic surgery to the study knee, including osteotomy around the knee
• Patient has an active, local infection or systemic infection
• Patient has physical, emotional or neurological conditions that would compromise compliance with postoperative rehabilitation and follow-up
• Patient has grade 3 collateral ligament insufficiency (complete tear of ligament)
• Patient has knee flexion <90 degrees
• Patient has fixed flexion deformity >10 degrees
• Patient has rheumatoid arthritis, any autoimmune disorder or immunosuppressive disorder
• Patient is pregnant or plans to become pregnant during course of study
• Patient has a known sensitivity to materials in the device and/or cutting blocks
• Patient has >30 degrees extension deficit

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Maximal passive knee flexion measured on a lateral X-ray one year after<br /><br>surgery.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Clinical, functional and radiological performance as measured with: active<br /><br>flexion (lying and standing), KSS, EQ-5d, KOOS, Kujala, Forgotten Knee Score,<br /><br>VAS Satisfaction, number and type of Adverse Events, Hip-Knee-Ankle angle,<br /><br>Patellar tilt & displacement.</p><br>