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Clinical Trials/NCT02319291
NCT02319291CompletedNot Applicable

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

DePuy Orthopaedics4 sites in 2 countries175 target enrollmentStarted: February 1, 2015Last updated:
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Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
175
Locations
4
Primary Endpoint
Implant Survivorship
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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.

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Other

Eligibility Criteria

Sex
All
Accepts Healthy Volunteers
No

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.

Outcomes

Primary Outcomes

Implant Survivorship

Time Frame: 5 years

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

Secondary Outcomes

  • Flexion(1, 3 & 5 years)
  • Knee Society Score - Function(1, 3 & 5 years)
  • Knee Society Score - Knee Score(1, 3 & 5 years)
  • Extension(1, 3 & 5 years)
  • Adverse Events(1, 3 & 5 years)
  • Pain sub-question of the Knee Society Score(1, 3 & 5 years)
  • Radiographic Analysis(1, 3 & 5 years)

Investigators

Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (4)

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