Safety and Performance of Journey II XR Total Knee System

Completed

• Conditions: Journey II XR Total Knee System

• Registration Number: NCT03798847
• Lead Sponsor: Smith & Nephew, Inc.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2018-11-01
• Study First Submitted: 2018-11-27
• Study First Submitted QC: 2019-01-07
• Study First Posted: 2019-01-10
• Primary Completion: 2020-09-10
• Study Completion: 2020-09-10
• Status Verified: 2023-07
• Last Update Submitted: 2023-07-12
• Last Update Posted: 2023-07-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 683

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

• None

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Revision of one or more study device components	12 weeks follow up	Measure of the number of revision cases

Secondary Outcome Measures

Name	Time	Method
Adverse Events	12 weeks follow up	All collected and reported AEs
Health Care Utilization: Re-operations	Implantation through study completion, approximately 3 years	Number of re-operations and revisions
Health care utilization: Hospitalization	Implantation through study completion, approximately 3 years	Hospitalizations (admission for inpatient care) occurring after the hospitalization for the index surgery (number and length of stay)
Health care utilization: Outpatient visits	Implantation through study completion, approximately 3 years	Number and type of outpatient visits
Technical Difficulties Encountered During Device Implantation	Implantation through study completion, approximately 3 years	Number of technical difficulties encountered with the device
Health care utilization: Rehabilitation	Implantation through study completion, approximately 3 years	number of sessions and duration of rehabilitation in weeks
Quality of Life: EQ-5D-3L	Implantation through study completion, approximately 3 years	EuroQol Five Dimensions Questionnaire
Return to Work	Implantation through study completion, approximately 3 years	Changes in employment status will be recorded with the date on which the change occurred and the change status.
Quality of Life: KSS	Implantation through study completion, approximately 3 years	2011 Knee Society Score

Trial Locations

Locations (12)

Orthopedic Institute of the West; 🇺🇸 Phoenix, Arizona, United States

Rush Copley Orthopaedics; 🇺🇸 Aurora, Illinois, United States

Jerry Orthopaedic Institute; 🇺🇸 Port Huron, Michigan, United States

Reno Orthopedic Clinic; 🇺🇸 Reno, Nevada, United States

Orthopaedic Center of New Jersey; 🇺🇸 Somerset, New Jersey, United States

Hospital for Joint Diseases Orthopaedics Institute; 🇺🇸 New York, New York, United States

Regenerative Orthopedic Center (ROC); 🇺🇸 Oregon City, Oregon, United States

Oregon Health & Science University; 🇺🇸 Portland, Oregon, United States

San Antonio Orthopaedic Specialists; 🇺🇸 San Antonio, Texas, United States

Anderson Orthopaedic Clinic; 🇺🇸 Alexandria, Virginia, United States

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