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The purpose of this study is to evaluate if the P.F.C. Sigma RPF knee accommodates functional stability with a post-operative passive range of motion of greater than 125° of flexion and to demonstrate that the range of motion does not compromise the longevity of the implant.
Primary endpoint is to demonstrate that 90% of patients have a functionally stable knee that can achieve post operative range of motion of 125 degrees or greater.
The secondary endpoint is to investigate the survivorship of the P.F.C. Sigma RP-F knee at 1, 2, 3, 5, 10, 15 and 20 years
Control: Uncontrolled, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
P.F.C. Sigma RP-F Total Knee Replacement
The Nook, 51/B SV Road
Active, not recruiting
Published on BioPortfolio: 2014-07-23T21:20:10-0400
100 knees with primary osteoarthritis and scheduled for a total knee replacement (TKR) will be recruited from our waiting list. The patients will be randomized to become operated with the ...
The primary objective of this investigation is to evaluate the performance (in terms of post-operative active range of motion at one year) of the P.F.C. Sigma and P.F.C. Sigma Rotating Pla...
Primary Research Questions: 1. Do patients with knee osteoarthritis (OA) who undergo total knee replacement with a Sigma rotating platform have better clinical outcomes at 2 years...
The main purpose of this study is to record information from clinical and radiographic examinations and patient assessment questionnaires before surgery and at suitable postoperative inter...
The main objective of this study is to determine if the P.F.C. Sigma RP-F Knee delivers a greater post-operative range of motion (ROM) compared with the P.F.C. Sigma RP Knee in primary TKA...
To evaluate validity and responsiveness of the Knee injury and Osteoarthritis Outcome Score (KOOS) in relation to other patient-reported outcome measures before and after total knee replacement (TKR).
Smoking has been associated with a reduced risk of hip and knee osteoarthritis and subsequent joint replacement. The aim of the present study was to assess whether the observed association is likely t...
Unicompartmental knee replacement (UKR) is an alternative to total knee replacement for selected patients with isolated medial or lateral compartment osteoarthritis. One of the most popular UKR implan...
The Main Cause of Death Following Primary Total Hip and Knee Replacement for Osteoarthritis: A Cohort Study of 26,766 Deaths Following 332,734 Hip Replacements and 29,802 Deaths Following 384,291 Knee Replacements.
Patients undergoing primary total joint replacement are selected for surgery and thus (other than having a transiently increased mortality rate postoperatively) have a lower mortality rate than age an...
This study aimed to support the potential protective role of anterior cruciate ligament (ACL) reconstruction against the development of osteoarthritis (OA).
Replacement of the knee joint.
Replacement for a knee joint.
Partial or total replacement of a joint.
Noninflammatory degenerative disease of the knee joint consisting of three large categories: conditions that block normal synchronous movement, conditions that produce abnormal pathways of motion, and conditions that cause stress concentration resulting in changes to articular cartilage. (Crenshaw, Campbell's Operative Orthopaedics, 8th ed, p2019)
Partial or total replacement of one or more FINGERS, or a FINGER JOINT.