A Study to Determine the Performance of the Press Fit Condylar (P.F.C.) Sigma RP-F Knee System
Summary
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.
Description
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
Study Design
Control: Uncontrolled, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Conditions
Osteoarthritis
Intervention
P.F.C. Sigma RP-F Total Knee Replacement
Location
The Nook, 51/B SV Road
Mumbai
Maharashtra
India
400 054
Status
Active, not recruiting
Source
DePuy International
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT00761410
- Information obtained from ClinicalTrials.gov on July 15, 2010
Medical and Biotech [MESH] Definitions
Arthroplasty, Replacement, Knee
Replacement of the knee joint.
Knee Prosthesis
Replacement for a knee joint.
Osteoarthritis, Knee
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)
Arthroplasty, Replacement
Partial or total replacement of a joint.
Arthroplasty, Replacement, Finger
Partial or total replacement of one or more FINGERS, or a FINGER JOINT.
Clinical Trials
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Long-term Study of The Press Fit Condylar (P.F.C.) Sigma Total Knee Replacement System
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PubMed Articles
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The lateral compartment is predominantly affected in approximately 10% of patients with osteoarthritis of the knee. The anatomy, kinematics and loading during movement differ considerably between medi...
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ABSTRACT: Objectives: To quantify the improvement in health outcomes in patients after total knee replacement (TKR). Methods: This was a two-year non-randomized prospective observational study in knee...
The association of osteoarthritis risk factors with localized, regional and diffuse knee pain.
OBJECTIVE: To identify determinants of different patterns of knee pain with a focus on risk factors for knee osteoarthritis. DESIGN: The Knee Pain Map is an interviewer-administered assessment that as...
