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Clinical Trials/NCT03903731
NCT03903731CompletedNot Applicable

Safety and Performance of Journey II BCS Total Knee System. A Retrospective, Multicenter Study. Patient Reported Outcomes Measures

Smith & Nephew, Inc.5 sites in 3 countries600 target enrollmentStarted: July 19, 2018Last updated:
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Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
600
Locations
5
Primary Endpoint
Revision of one or more study device components
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

Safety and Performance of Journey II BCS Total Knee System. A Retrospective, Multicenter Study. Patient Reported Outcome Measures.

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Retrospective

Eligibility Criteria

Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •Subject received primary uni- or bi-lateral total knee arthroplasty with the Journey II BCS Total Knee System for approved indication;
  • •The TKA occurred at least 12 weeks prior to enrollment
  • •Subject records contain Patient Reported Outcome data obtained ≤3 months prior to as well as ≥6 months post-enrollment.

Exclusion Criteria

  • •Subject received the JOURNEY II BCS Total Knee System on the affected knee as a revision for a previously failed total or unicondylar knee arthroplasty

Outcomes

Primary Outcomes

Revision of one or more study device components

Time Frame: Implantation through study completion, approximately 8 years

We are measuring the number of revision cases

Secondary Outcomes

  • Health care utilization: Rehabilitation(Implantation through study completion, approximately 8 years)
  • Knee Injury and Osteoarthritic Outcome Score (KOOS)(Baseline through last study visit, approximately 8 years)
  • Knee Injury and Osteoarthritic Outcome Score Jr (KOOS Jr)(Baseline through last study visit, approximately 8 years)
  • Knee Society Score (KSS)(Baseline through last study visit, approximately 8 years)
  • Return to Work(Implantation through study completion, approximately 8 years)
  • Western Ontario and McMaster Universities Osteoarthritis (WOMAC) Index(Baseline through last study visit, approximately 8 years)
  • Oxford Knee Assessment (OKS)(Baseline through last study visit, approximately 8 years)
  • Visual Analogue Scale (VAS)(Baseline through last study visit, approximately 8 years)
  • SF-12 Version 1(Baseline through last study visit, approximately 8 years)
  • Total Knee Assessment Score(Baseline through last study visit, approximately 8 years)

Investigators

Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (5)

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