Clinical trial NCT03903731: Safety and Performance of Journey II BCS Total Knee System Patient Reported Outcome Measures
Official title: Safety and Performance of Journey II BCS Total Knee System. A Retrospective, Multicenter Study. Patient Reported Outcomes Measures
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Journey II BCS Total Knee System
Lead sponsor: Smith & Nephew, Inc.
Sponsor class: INDUSTRY
First posted: 2019-04-04
Enrollment: 600
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects who received the Journey II BCS Total Knee System

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


Eligibility criteria: 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

Primary outcomes:
measure: Revision of one or more study device components
timeFrame: Implantation through study completion, approximately 8 years
Secondary outcomes:
measure: Health care utilization: Rehabilitation
timeFrame: Implantation through study completion, approximately 8 years
measure: Return to Work
timeFrame: Implantation through study completion, approximately 8 years
measure: Knee Society Score (KSS)
timeFrame: Baseline through last study visit, approximately 8 years
measure: Visual Analogue Scale (VAS)
timeFrame: Baseline through last study visit, approximately 8 years
measure: Western Ontario and McMaster Universities Osteoarthritis (WOMAC) Index
timeFrame: Baseline through last study visit, approximately 8 years
measure: Total Knee Assessment Score
timeFrame: Baseline through last study visit, approximately 8 years
measure: Oxford Knee Assessment (OKS)
timeFrame: Baseline through last study visit, approximately 8 years
measure: Knee Injury and Osteoarthritic Outcome Score (KOOS)
timeFrame: Baseline through last study visit, approximately 8 years
measure: Knee Injury and Osteoarthritic Outcome Score Jr (KOOS Jr)
timeFrame: Baseline through last study visit, approximately 8 years
measure: SF-12 Version 1
timeFrame: Baseline through last study visit, approximately 8 years
Other outcomes:
Locations:
city: Aurora
country: United States
facility: Department of Orthopaedics, University of Colorado Denver
state: Colorado
city: New York
country: United States
facility: Hospital for Special Surgery
state: New York
city: Knoxville
country: United States
facility: Tennessee Orthopaedic Clinics
state: Tennessee
city: Leuven
country: Belgium
facility: UZ Leuven
city: Hamilton
country: New Zealand
facility: Anglesea Clinic Orthopaedics
Study officials:
affiliation: Department of Orthopaedics, University of Colorado Denver
name: Michael R. Dayton, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital for Special Surgery, New York
name: David J. Mayman, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Tennessee Orthopaedic Clinics
name: Harold E. Cates, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: UZ Leuven
name: Hilde Vandenneucker, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Anglesea Clinic Orthopaedics
name: Peter Black, MBBCh
role: PRINCIPAL_INVESTIGATOR
References: