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Clinical Trials/NCT03798847
NCT03798847
Completed
N/A

Safety and Performance of Journey II XR Total Knee System. A Retrospective, Multicenter Study

Smith & Nephew, Inc.12 sites in 1 country683 target enrollmentNovember 1, 2018
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ConditionsJourney II XR Total Knee System

Overview

Phase
N/A
Intervention
Not specified
Conditions
Journey II XR Total Knee System
Sponsor
Smith & Nephew, Inc.
Enrollment
683
Locations
12
Primary Endpoint
Revision of one or more study device components
Status
Completed
Last Updated
2 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar Trials

Overview

Brief Summary

The objective of this study is to estimate the safety and performance of Journey II XR TKS based on retrospective data.

Registry
clinicaltrials.gov
Start Date
November 1, 2018
End Date
September 10, 2020
Last Updated
2 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • •Subject received primary uni- or bi-lateral total knee arthroplasty with the Journey II XR TKS for approved indication;
  • •The TKA occurred at least 12 weeks prior to enrollment.

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Revision of one or more study device components

Time Frame: 12 weeks follow up

Measure of the number of revision cases

Secondary Outcomes

  • Health Care Utilization: Re-operations(Implantation through study completion, approximately 3 years)
  • Health care utilization: Hospitalization(Implantation through study completion, approximately 3 years)
  • Health care utilization: Outpatient visits(Implantation through study completion, approximately 3 years)
  • Technical Difficulties Encountered During Device Implantation(Implantation through study completion, approximately 3 years)
  • Adverse Events(12 weeks follow up)
  • Health care utilization: Rehabilitation(Implantation through study completion, approximately 3 years)
  • Quality of Life: EQ-5D-3L(Implantation through study completion, approximately 3 years)
  • Return to Work(Implantation through study completion, approximately 3 years)
  • Quality of Life: KSS(Implantation through study completion, approximately 3 years)

Study Sites (12)

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