A Study to Determine the Performance of the Press Fit Condylar (P.F.C.) Sigma RP-F Knee System
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
Results (where available)
- Source: http://clinicaltrials.gov/show/NCT00761410
- Information obtained from ClinicalTrials.gov on July 15, 2010
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 ...
Genetic factors play an important role in the pathogenesis of knee osteoarthritis (OA), but which knee structural changes mediate this is unclear. This study aimed to describe the differences in knee ...
The aim of this review article is to analyze the clinical effectiveness of total knee replacement (TKR) compared to unicompartmental knee replacement (UKR) in patients with medial unicompartmental ost...
The role of the microcirculation in the pathogenesis of osteoarthritis remains unclear. This prospective cohort study examined the association between retinal vascular calibre and incidence of knee re...
Background and purpose - It is unclear whether mobile-bearing (MB) total knee arthroplasties reduce the risk of tibial component loosening compared to fixed-bearing (FB) designs. This randomized study...
Does high flexion after total knee replacement really improve our patients' quality of life at a short-term follow-up? : A comparative case-control study with hyperflex PFC Sigma versus a Triathlon knee series.
A full range of motion after total knee arthroplasty has become more and more requested by our patients, leading to novel designs of knee implants, the so-called "hyperflex" knees. The aim of the pres...
Medical and Biotech [MESH] Definitions
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.