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

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

Status

Terminated

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00289081

Enrollment

399

Registered

2006-02-09

Start date

2001-02-28

Completion date

2006-06-30

Last updated

2014-05-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

Total Knee Replacement

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.

Interventions

DEVICETotal Knee Replacement

Rotating Platform (RP) Cruciate Retaining Knee implant

DEVICETotal knee replacement

Rotating Platform (RP) Cruciate Substituting Knee implant.

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

Measure	Time frame
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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026