NCT00733369

A Study to Compare the Press Fit Condylar (P.F.C.) Sigma Rotating-platform High-flexion (RP-F) Versus the Press Fit Condylar (P.F.C.) Sigma Rotating-platform (RP) Knee Implants

A Prospective, Single Blinded, Multi-centre Randomised Controlled Trial Comparing the Post Operative Range of Motion of the P.F.C. Sigma RP-F Knee With the P.F.C. Sigma RP Knee in Primary Total Knee Arthroplasty.

• Status: Terminated
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 106 (actual)
• Sponsor: DePuy International · Industry
• Sex: All
• Age: 45 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

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 secondary objectives of this investigation are to evaluate the clinical and patient outcomes and survivorship associated with the DePuy P.F.C. Sigma RP-F and RP Posterior Stabilised (PS) Knee over 5 years.

Detailed description

Primary Outcome: Change from pre-operative range of motion at 1 year between patients receiving P.F.C. Sigma RP vs P.F.C. Sigma RP-F Secondary endpoints: Comparative evaluation of any post-operative variation between subjects receiving primary TKA with either of the above devices in terms of Knee and Osteoarthritis Scores (KOOS), American Knee Society Score (AKS), EQ-5D Score and Oxford Knee Score (OKS)

Conditions

• Knee Osteoarthritis

Interventions

Type	Name	Description
DEVICE	PFC Sigma RP-F	An orthopaedic implant for total knee replacement with a high flexion rotating platform bearing
DEVICE	PFC Sigma RP	An orthopaedic implant for total knee replacement with a standard flexion rotating platform bearing

Timeline

• Start date: 2007-11-01
• Primary completion: 2010-08-01
• Completion: 2014-08-01
• First posted: 2008-08-13
• Last updated: 2016-09-13
• Results posted: 2014-08-26

Locations

2 sites across 2 countries: Spain, United Kingdom