PS150 Total Knee Arthroplasty Outcomes Registry

February 21, 2023 updated by: DePuy Orthopaedics

Outcomes of Total Knee Arthroplasty (TKA) Using the Sigma PS150 Primary Total Knee System

This registry is intended to evaluate the clinical outcomes of the DePuy P.F.C. Sigma PS150 RP Total Knee System. 200 participants will be enrolled prospectively or retrospectively and the follow up period will be 5 years. Data collection will include Radiographic Analysis, Knee Society Evaluation and Adverse Events.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

175

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
      • Greenslopes, Australia
        • Greenslopes Private Hospital
      • Sydney, Australia
        • Northern Orthopaedics
  • Korea, Republic of
      • Incheon, Korea, Republic of, 405-760
        • Gachon University Gil Medical Center
      • Jeju, Korea, Republic of, 690-767
        • Jeju National University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients may be considered for inclusion in the registry if they meet the inclusion criteria below.

Description

Inclusion Criteria:

  • Primary total knee replacement for any indication in accordance with the Instructions For Use accompanying the SIGMA PS150 implant.
  • Signed Informed Patient Consent

Exclusion Criteria:

  • There are no exclusion criteria for this registry.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Other

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Participants
P.F.C. Sigma PS150 RP Total Knee System
Device: P.F.C. Sigma PS150 RP Total Knee System
Total Knee Arthroplasty - surgical procedure to replace knee with metal implant

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Implant Survivorship
Time Frame: 5 years
Lack of revision with revision meaning no removal or replacement of any TKA component.
5 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Knee Society Score - Knee Score
Time Frame: 1, 3 & 5 years
Descriptive statistics, including change from baseline (post-op minus pre-op)
1, 3 & 5 years
Knee Society Score - Function
Time Frame: 1, 3 & 5 years
Descriptive statistics, including change from baseline (post-op minus pre-op)
1, 3 & 5 years
Pain sub-question of the Knee Society Score
Time Frame: 1, 3 & 5 years
Descriptive statistics, including change from baseline (post-op minus pre-op)
1, 3 & 5 years
Flexion
Time Frame: 1, 3 & 5 years
Descriptive statistics, including change from baseline (post-op minus pre-op)
1, 3 & 5 years
Extension
Time Frame: 1, 3 & 5 years
Descriptive statistics, including change from baseline (post-op minus pre-op)
1, 3 & 5 years
Radiographic Analysis
Time Frame: 1, 3 & 5 years
Descriptive statistics
1, 3 & 5 years
Adverse Events
Time Frame: 1, 3 & 5 years
Type and frequency of adverse events
1, 3 & 5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

DePuy Orthopaedics

Investigators

  • Principal Investigator: Mark Dekkers, MBBS, Greenslopes Private Hospital, Brisbane

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2015

Primary Completion (Actual)

November 3, 2021

Study Completion (Actual)

November 3, 2021

Study Registration Dates

First Submitted

December 15, 2014

First Submitted That Met QC Criteria

December 17, 2014

First Posted (Estimate)

December 18, 2014

Study Record Updates

Last Update Posted (Estimate)

February 22, 2023

Last Update Submitted That Met QC Criteria

February 21, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 13004

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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