Safety and Performance of JOURNEY™ II Cruciate Retaining (CR) Total Knee System (TKS)

Completed

• Conditions: Journey II CR Total Knee System

• Registration Number: NCT03885531
• Lead Sponsor: Smith & Nephew, Inc.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-03-06
• Study First Submitted QC: 2019-03-19
• Study First Posted: 2019-03-21
• Study Start: 2019-03-27
• Primary Completion: 2020-06-30
• Study Completion: 2020-06-30
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-02
• Last Update Posted: 2024-01-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 586

Inclusion Criteria

• Subject received primary uni- or bilateral TKA with the Journey II CR TKS for an 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
Number of adverse events reported per ISO 14155 guidelines	7 years

Secondary Outcome Measures

Name	Time	Method
Length of hospital stay for primary (index) surgery	7 years
Number and type of outpatient visits	7 years
Number of days before return to work	7 years
Number of rehabilitation sessions	7 years
Number of technical difficulties encountered with the device	7 years
Number of hospitalizations (admission for inpatient care) occurring after the hospitalization for the index surgery	7 years
Duration of rehabilitation sessions in weeks	7 years
Number of re-operations	7 years
Quality of Life as measured by EQ-5D-3L score	7 years	The EQ-5D-3L will be collected at each follow up visit. It consists of two pages - the EQ-5D descriptive system (page one) and the EQ visual analogue scale (EQ VAS) (page two). The descriptive system consists of five dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) each of which takes one of three responses. The responses record three levels of severity (no problems/some or moderate problems/extreme problems) within a particular dimension. The EQ VAS records the respondent's self-rated health on a vertical, visual analogue scale where the endpoints are labelled 'Best imaginable health state' and 'Worst imaginable health state'. This information can be used as a quantitative measure of health outcome as judged by the individual respondents.
Patient Pain Level as measured by Knee Society Score (KSS)	7 years	Combines an objective physician-derived component with a subjective subject-derived component. The objective section rates alignment, instability, joint motion and symptoms. Patient reported expectations and satisfaction questions evaluate pain relief, functional abilities, satisfaction and fulfillment of expectations using a subjective perspective. A functional score is derived from assessments of walking and standing, standard activities, advanced activities and discretionary activities.
Length of stay of hospitalizations (admission for inpatient care) occurring after the hospitalization for the index surgery	upon occurence through 7 years of study duration

Trial Locations

Locations (6)

Tennessee Orthopaedic Clinics; 🇺🇸 Knoxville, Tennessee, United States

Orthopaedic Specialists of Scottsdale; 🇺🇸 Scottsdale, Arizona, United States

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

Pikeville Medical Center; 🇺🇸 Pikeville, Kentucky, United States

New York University; 🇺🇸 New York, New York, United States

OrthoNeuro; 🇺🇸 New Albany, Ohio, United States