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Clinical Trials/NCT02319291
NCT02319291
Completed
Not Applicable

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

DePuy Orthopaedics4 sites in 2 countries175 target enrollmentFebruary 1, 2015
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ConditionsOsteoarthritisRheumatoid Arthritis

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Osteoarthritis
Sponsor
DePuy Orthopaedics
Enrollment
175
Locations
4
Primary Endpoint
Implant Survivorship
Status
Completed
Last Updated
3 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar Trials

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.

Registry
clinicaltrials.gov
Start Date
February 1, 2015
End Date
November 3, 2021
Last Updated
3 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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)

Study Sites (4)

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