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

04:11 EDT 21st September 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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Replacement for a knee joint.

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