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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
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...
The purpose of the study is to investigate the density, architecture, and perfusion of bone marrow lesions (BMLs) in knee osteoarthritis. We will perform MRI's and QCT's on subjects prior ...
To estimate the lifetime risk of knee osteoarthritis (OA) and total knee replacement (TKR) in persons sustaining ACL tear by age 25.
Background More than 670,000 total knee replacements are performed annually in the United States; however, high-quality evidence to support the effectiveness of the procedure, as compared with nonsurg...
Joint replacement surgery is one of the most often performed routine procedures for the treatment of knee osteoarthritis in Germany. Currently, there is no consensus on indication criteria for total k...
The relation of knee replacement (KR) surgery to all-cause mortality has not been well established owing to potential biases in previous studies. Thus, we aimed to examine the relation of KR to mortal...
A Randomized, Controlled Trial of Total Knee Replacement Original Article, N Engl J Med 2015;373:1597-1606. In the Participants subsection of Methods (page 1598), the second exclusion criterion in the...
Replacement of the knee joint.
Replacement for a knee 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 a joint.
Partial or total replacement of one or more FINGERS, or a FINGER JOINT.