Primary TKA Cruciate Retaining vs Cruciate Substituting With Rotating Platform Knee Prostheses

Not Applicable

Terminated

• Conditions: Osteoarthritis; Arthritis, Rheumatoid; Avascular Necrosis of Bone; Post-traumatic Arthritis; Rheumatoid Arthritis
• Interventions: Device: Total knee replacement

• Registration Number: NCT00289081
• Lead Sponsor: DePuy Orthopaedics

Brief Summary

The purpose of the study is to evaluate the clinical performance of the cruciate ligament retaining or cruciate ligament substituting implants by obtaining a series of primary TKAs. Outcome scoring and radiographic assessment will be the methods used to evaluate performance.

Detailed Description

The study will evaluate the clinical performance of cruciate ligament retaining or cruciate ligament substituting implants through a series of primary TKAs. Patients will receive either the P.F.C.® Sigma™ Rotating Platform Cruciate Retaining Knee implant or the P.F.C.® Sigma™ Rotating Platform Cruciate Substituting Knee implant and assignment will be randomized.

Study Timeline

• Study Start: 2001-02
• Study First Submitted: 2006-02-07
• Study First Submitted QC: 2006-02-07
• Study First Posted: 2006-02-09
• Primary Completion: 2006-06
• Study Completion: 2006-06
• Status Verified: 2014-05
• Last Update Submitted: 2014-05-12
• Last Update Posted: 2014-05-13

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 399

Inclusion Criteria

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

Exclusion Criteria

• Prior ipsilateral TKA
• Metabolic disorders
• Joint replacement due to autoimmune disorders
• 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
• Severe diabetes mellitus
• Skeletal immaturity

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Total knee replacement	Rotating Platform Cruciate Retaining Knee implant
2	Total knee replacement	Rotating Platform Cruciate Substituting Knee implant.

Primary Outcome Measures

Name	Time	Method
Knee Society scores	Pre-operative, 6 and 12 months and annually thereafter for at least 5 years.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

West Coast Orthopaedic Specialists; 🇺🇸 Crystal River, Florida, United States