Skip to main content
OpenTrials
Completed

NCT Number: NCT00289094

Randomized Fixed Bearing vs Mobile Bearing Cruciate Retaining TKA

The purpose of this study is to evaluate the clinical performance of the rotating platform and fixed bearing implants in patients undergoing primary total knee replacement. Outcome scoring and radiographic assessment will be the methods used to evaluate performance.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Osteoarthritis Arthritis Arthritis, Juvenile Arthritis, Rheumatoid Autoimmune Diseases Avascular Necrosis of Bone Bone Diseases Connective Tissue Diseases Immune System Diseases Joint Diseases Juvenile Rheumatoid Arthritis Musculoskeletal Diseases Necrosis Osteonecrosis Pathologic Processes Pathological Conditions, Signs and Symptoms Post-traumatic Arthritis Rheumatic Diseases Rheumatoid Arthritis Skin and Connective Tissue Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Billings, Montana, United States

Loading trial locations.

About this study

This study will evaluate the clinical performance of rotating platform and fixed bearing knee implants. This will be done by obtaining a series of primary total knee replacements. Patients will receive either the P.F.C.® Sigma™ Rotating Platform Cruciate Retaining Knee System or the P.F.C.® Sigma™ Fixed Cruciate Retaining Knee System and assignment is randomized.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Osteoarthritis
  • Rheumatoid Arthritis
  • Other inflammatory arthritis
  • Avascular necrosis of bone

Exclusion criteria

  • Prior ipsilateral TKA
  • Metabolic disorders
  • Joint replacement due to autoimmune disorders

Treatment and study plan

Total knee replacement

Device

Rotating Platform (RP) Cruciate Retaining Knee System

Other names: P.F.C.® Sigma™ RP Cruciate Retaining Knee System

Primary outcomes

  1. Knee Society Scores

    Time frame: Pre-operative, 6 and 12 months and annually thereafter for at least 5 years.

    The Knee Society Score (KSS) is comprised to two sections (each worth 100 points) for a maximum 200 points. One section is the Knee Society Clinical Score (KSCS) - points are given for pain, motion, and stability and points are deducted for flexion contracture, extension lag, and misalignment. The other section is the Knee Society Functional Score (KSFS) - points are assigned for walking distances and climbing stairs and points are deducted for use of walking aids. For each section, a score of 80-100 = excellent, 70-79 = good; 60-69 = fair; and < 60 = poor.

Secondary outcomes

  1. Complications/Revisions

    Time frame: On-going to end of study.

  2. Medical Imaging

    Time frame: Pre-operative, 6 and 12 months and annually thereafter for at least 5 years.

  3. SF-12 Patient Outcomes

    Time frame: Pre-operative, 6 and 12 months and annually thereafter for at least 5 years.

Sponsors and collaborators

Lead sponsor

DePuy Orthopaedics

Industry

Registry information

Official study title

Multi-center, Prospective, Clinical Evaluation of the PFC Sigma Rotating Platform Cruciate Retaining Versus PFC Sigma Cruciate Retaining Knee Primary Cases

Important dates

Study start
2001
Primary completion
2007
Study completion
2007
First posted
Feb 9, 2006
Registry last updated
Sep 13, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.