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Completed

NCT Number: NCT02319291

PS150 Total Knee Arthroplasty Outcomes Registry

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.

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Key information

Conditions

Osteoarthritis Arthritis Arthritis, Rheumatoid Autoimmune Diseases Connective Tissue Diseases Immune System Diseases Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Rheumatoid Arthritis Skin and Connective Tissue Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

Greenslopes Private Hospital, Greenslopes, Australia

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Device

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

Primary outcomes

  1. Implant Survivorship

    Time frame: 5 years

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

Secondary outcomes

  1. Knee Society Score - Knee Score

    Time frame: 1, 3 & 5 years

    Descriptive statistics, including change from baseline (post-op minus pre-op)

  2. Knee Society Score - Function

    Time frame: 1, 3 & 5 years

    Descriptive statistics, including change from baseline (post-op minus pre-op)

  3. 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)

  4. Flexion

    Time frame: 1, 3 & 5 years

    Descriptive statistics, including change from baseline (post-op minus pre-op)

  5. Extension

    Time frame: 1, 3 & 5 years

    Descriptive statistics, including change from baseline (post-op minus pre-op)

  6. Radiographic Analysis

    Time frame: 1, 3 & 5 years

    Descriptive statistics

  7. Adverse Events

    Time frame: 1, 3 & 5 years

    Type and frequency of adverse events

Sponsors and collaborators

Lead sponsor

DePuy Orthopaedics

Industry

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2021
Study completion
2021
First posted
Dec 18, 2014
Registry last updated
Feb 22, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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