A Study to Determine the Performance of the Press Fit Condylar (P.F.C.) Sigma RP-F Knee System

09:06 EDT 20th October 2014 | BioPortfolio

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)

View Results

Links

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Medical and Biotech [MESH] Definitions

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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.

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