NCT02319291

Brief Summary

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
175

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Feb 2015

Longer than P75 for all trials

Geographic Reach
2 countries

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 15, 2014

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 18, 2014

Completed
2 months until next milestone

Study Start

First participant enrolled

February 1, 2015

Completed
6.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 3, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 3, 2021

Completed
Last Updated

February 22, 2023

Status Verified

February 1, 2023

Enrollment Period

6.8 years

First QC Date

December 15, 2014

Last Update Submit

February 21, 2023

Conditions

OsteoarthritisRheumatoid Arthritis

Outcome Measures

Primary Outcomes (1)

  • Implant Survivorship

    Lack of revision with revision meaning no removal or replacement of any TKA component.

    5 years

Secondary Outcomes (7)

  • Knee Society Score - Knee Score

    1, 3 & 5 years

  • Knee Society Score - Function

    1, 3 & 5 years

  • Pain sub-question of the Knee Society Score

    1, 3 & 5 years

  • Flexion

    1, 3 & 5 years

  • Extension

    1, 3 & 5 years

  • +2 more secondary outcomes

Study Arms (1)

Participants

P.F.C. Sigma PS150 RP Total Knee System

Device: P.F.C. Sigma PS150 RP Total Knee System

Interventions

P.F.C. Sigma PS150 RP Total Knee SystemDEVICE

Total Knee Arthroplasty - surgical procedure to replace knee with metal implant

Participants

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Greenslopes Private Hospital

Greenslopes, Australia

Location

Northern Orthopaedics

Sydney, Australia

Location

Gachon University Gil Medical Center

Incheon, 405-760, South Korea

Location

Jeju National University Hospital

Jeju City, 690-767, South Korea

Location

MeSH Terms

Conditions

OsteoarthritisArthritis, Rheumatoid

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Mark Dekkers, MBBS

    Greenslopes Private Hospital, Brisbane

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
OTHER
Target Duration
5 Years
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 15, 2014

First Posted

December 18, 2014

Study Start

February 1, 2015

Primary Completion

November 3, 2021

Study Completion

November 3, 2021

Last Updated

February 22, 2023

Record last verified: 2023-02

Locations

AU(2)KR(2)