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

Rheumatoid Arthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00289081
• Other study ID #: SRP-1
• Status: Terminated
• Phase: N/A
• First received: February 7, 2006
• Last updated: May 12, 2014
• Start date: February 2001
• Est. completion date: June 2006

Study information

• Verified date: May 2014
• Source: DePuy Orthopaedics
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 399
• Est. completion date: June 2006
• Est. primary completion date: June 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

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

Intervention

Device:
• Total Knee Replacement
Rotating Platform (RP) Cruciate Retaining Knee implant
• Total knee replacement
Rotating Platform (RP) Cruciate Substituting Knee implant.

Locations

Country	Name	City	State
United States	West Coast Orthopaedic Specialists	Crystal River	Florida

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		Pre-operative, 6 and 12 months and annually thereafter for at least 5 years.	No
Secondary	Complications		On-going to end of study	Yes
Secondary	Revisions		On-going to end of study	Yes
Secondary	Medical imaging		Pre-operative, 6 and 12 months and annually thereafter for at least 5 years.	Yes
Secondary	SF-12 patient outcomes		Pre-operative, 6 and 12 months and annually thereafter for at least 5 years.	No