Randomized Fixed Bearing vs Mobile Bearing Cruciate Substituting TKA

Not Applicable

Completed

• Conditions: Osteoarthritis; Juvenile Rheumatoid Arthritis; Other Inflammatory Arthritis; Post-Traumatic Arthritis; Rheumatoid Arthritis; Avascular Necrosis
• Interventions: Device: Total Knee Arthroplasty; Device: Total knee replacement

• Registration Number: NCT00289107
• Lead Sponsor: DePuy Orthopaedics

Brief Summary

The study will evaluate the clinical performance of the rotating platform and fixed bearing implants through patient questionnaires, outcomes scoring and radiographic assessment.

Detailed Description

The study will evaluate the clinical performance of rotating platform and fixed bearing cruciate ligament substituting implants by obtaining a series of primary TKAS. Patients will receive either the P.F.C.® Sigma™ Rotating Platform Cruciate Substituting Knee System or P.F.C.® Sigma™ Fixed Cruciate Substituting Knee System and assignment is randomized.

Study Timeline

• Study Start: 2001-04-01
• Study First Submitted: 2006-02-07
• Study First Submitted QC: 2006-02-07
• Study First Posted: 2006-02-09
• Primary Completion: 2007-11-01
• Study Completion: 2007-11-01
• Results First Submitted: 2010-09-29
• Results First Submitted QC: 2010-11-12
• Results First Posted: 2010-12-10
• Status Verified: 2023-03
• Last Update Submitted: 2023-04-04
• Last Update Posted: 2023-05-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 149

Inclusion Criteria

• Osteoarthritis
• Rheumatoid arthritis
• Other inflammatory arthritis
• Avascular necrosis (AVN) of bone
• Post-Traumatic Arthritis
• Juvenile Rheumatoid Arthritis

Exclusion Criteria

• History of recent/active joint sepsis.
• Charcot neuropathy.
• Psycho-social disorders that would limit rehabilitation.
• Greater than 75 years of age at the time of surgery.
• Prior ipsilateral knee arthroplasty.
• Metabolic disorders of calcified tissues, such as Paget's disease.
• Severe diabetes mellitus.
• Joint replacement due to autoimmune disorders.
• Skeletal immaturity

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Total Knee Arthroplasty	P.F.C.® Sigma™ Rotating Platform Cruciate Substituting Knee System
2	Total knee replacement	P.F.C.® Sigma™ Fixed Cruciate Substituting Knee System

Primary Outcome Measures

Name	Time	Method
Knee Society Score	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 Outcome Measures

Name	Time	Method
Complications	On-going to end of study
Medical Imaging	Pre-operative, 6 and 12 months and annually thereafter for at least 5 years.
Revisions	On-going to end of study
SF-12 Patient Outcomes	Pre-operative, 6 and 12 months and annually thereafter for at least 5 years.