Randomized Fixed Bearing vs Mobile Bearing Cruciate Substituting TKA

Rheumatoid Arthritis Clinical Trial

Official title:

Multi-center, Prospective, Clinical Evaluation of the P.F.C.® Sigma™ Rotating Platform Cruciate Substituting vs P.F.C.® Sigma™ Cruciate Substituting Knee Primary Cases

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00289107
• Other study ID #: SRP-3
• Status: Completed
• Phase: N/A
• Start date: April 1, 2001
• Est. completion date: November 1, 2007

Study information

• Verified date: March 2023
• Source: DePuy Orthopaedics
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 149
• Est. completion date: November 1, 2007
• Est. primary completion date: November 1, 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 (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

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Juvenile
• Arthritis, Rheumatoid
• Avascular Necrosis
• Juvenile Rheumatoid Arthritis
• Necrosis
• Osteoarthritis
• Other Inflammatory Arthritis
• Post-Traumatic Arthritis
• Rheumatoid Arthritis

Intervention

Device:
• Total Knee Arthroplasty
Rotating Platform (RP) Cruciate Substituting Knee System
• Total knee replacement
Fixed Cruciate Substituting 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 Score	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		On-going to end of study
Secondary	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.