Randomized Fixed Bearing vs Mobile Bearing Cruciate Retaining TKA

Rheumatoid Arthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00289094
• Other study ID #: SRP-2
• Status: Completed
• Phase: N/A
• Start date: March 1, 2001
• Est. completion date: December 26, 2007

Study information

• Verified date: July 2022
• Source: DePuy Orthopaedics
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 99
• Est. completion date: December 26, 2007
• Est. primary completion date: December 26, 2007
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Juvenile
• Arthritis, Rheumatoid
• Avascular Necrosis of Bone
• Juvenile Rheumatoid Arthritis
• Necrosis
• Osteoarthritis
• Osteonecrosis
• Post-traumatic Arthritis
• Rheumatoid Arthritis

Intervention

Device:
• Total Knee Replacement
Rotating Platform (RP) Cruciate Retaining Knee System
• Total knee replacement
Fixed Cruciate Retaining Knee System

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
DePuy Orthopaedics

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Knee Society Scores	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.	Pre-operative, 6 and 12 months and annually thereafter for at least 5 years.
Secondary	Complications/Revisions		On-going to end of study.
Secondary	Medical Imaging		Pre-operative, 6 and 12 months and annually thereafter for at least 5 years.
Secondary	SF-12 Patient Outcomes		Pre-operative, 6 and 12 months and annually thereafter for at least 5 years.