PS150 Total Knee Arthroplasty Outcomes Registry

NCT ID: NCT02319291

Last Updated: 2023-02-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

175 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-02-01

Study Completion Date

2021-11-03

Brief Summary

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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.

Detailed Description

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Conditions

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Osteoarthritis Rheumatoid Arthritis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

OTHER

Study Groups

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Participants

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

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

Intervention Type DEVICE

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

Interventions

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

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

Intervention Type DEVICE

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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DePuy Orthopaedics

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Mark Dekkers, MBBS

Role: PRINCIPAL_INVESTIGATOR

Greenslopes Private Hospital, Brisbane

Locations

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Greenslopes Private Hospital

Greenslopes, , Australia

Site Status

Northern Orthopaedics

Sydney, , Australia

Site Status

Gachon University Gil Medical Center

Incheon, , South Korea

Site Status

Jeju National University Hospital

Jeju City, , South Korea

Site Status

Countries

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Australia South Korea

Other Identifiers

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13004

Identifier Type: -

Identifier Source: org_study_id

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