Randomized Fixed Bearing vs Mobile Bearing Cruciate Retaining TKA

NCT ID: NCT00289094

Last Updated: 2022-09-13

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

99 participants

Study Classification

INTERVENTIONAL

Study Start Date

2001-03-01

Study Completion Date

2007-12-26

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The purpose of this study is to evaluate the clinical performance of the rotating platform and fixed bearing implants in patients undergoing primary total knee replacement. Outcome scoring and radiographic assessment will be the methods used to evaluate performance.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

This study will evaluate the clinical performance of rotating platform and fixed bearing knee implants. This will be done by obtaining a series of primary total knee replacements. Patients will receive either the P.F.C.® Sigma™ Rotating Platform Cruciate Retaining Knee System or the P.F.C.® Sigma™ Fixed Cruciate Retaining Knee System and assignment is randomized.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

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

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

1

P.F.C.® Sigma™ Rotating Platform (RP) Cruciate Retaining Knee System

Group Type ACTIVE_COMPARATOR

Total Knee Replacement

Intervention Type DEVICE

Rotating Platform (RP) Cruciate Retaining Knee System

2

P.F.C.® Sigma™ Fixed Cruciate Retaining Knee System

Group Type ACTIVE_COMPARATOR

Total knee replacement

Intervention Type DEVICE

Fixed Cruciate Retaining Knee System

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Total Knee Replacement

Rotating Platform (RP) Cruciate Retaining Knee System

Intervention Type DEVICE

Total knee replacement

Fixed Cruciate Retaining Knee System

Intervention Type DEVICE

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

P.F.C.® Sigma™ RP Cruciate Retaining Knee System P.F.C.® Sigma™ Fixed Cruciate Retaining Knee System

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Osteoarthritis
* Rheumatoid Arthritis
* Other inflammatory arthritis
* Avascular necrosis of bone

Exclusion Criteria

* Prior ipsilateral TKA
* Metabolic disorders
* Joint replacement due to autoimmune disorders
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

DePuy Orthopaedics

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Tammy L O'Dell, EMT, CCRA, CCRC

Role: STUDY_DIRECTOR

DePuy Orthopaedics

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Billings, Montana, United States

Site Status

Vancouver, Washington, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

SRP-2

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

PFC Sigma Fixed and Mobile Knee Study
NCT00208325 TERMINATED PHASE4