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

• ClinicalTrials.gov Identifier: NCT03885531
• Recruitment Status: Recruiting
• First Posted: March 21, 2019
• Last Update Posted: May 5, 2020
• Sponsor: Smith & Nephew, Inc.
• Collaborator: Nor Consult
• Information provided by (Responsible Party): Smith & Nephew, Inc.

Tracking Information

• First Submitted Date: March 6, 2019
• First Posted Date: March 21, 2019
• Last Update Posted Date: May 5, 2020
• Actual Study Start Date: March 27, 2019
• Estimated Primary Completion Date: July 31, 2020 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: March 19, 2019): Number of adverse events reported per ISO 14155 guidelines [ Time Frame: 7 years ]
• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: March 28, 2019)

• Length of hospital stay for primary (index) surgery [ Time Frame: 7 years ]
• Number of hospitalizations (admission for inpatient care) occurring after the hospitalization for the index surgery [ Time Frame: 7 years ]
• Length of stay of hospitalizations (admission for inpatient care) occurring after the hospitalization for the index surgery [ Time Frame: upon occurence through 7 years of study duration ]
• Number of rehabilitation sessions [ Time Frame: 7 years ]
• Duration of rehabilitation sessions in weeks [ Time Frame: 7 years ]
• Number and type of outpatient visits [ Time Frame: 7 years ]
• Number of re-operations [ Time Frame: 7 years ]
• Quality of Life as measured by EQ-5D-3L score [ Time Frame: 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) [ Time Frame: 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.
• Number of days before return to work [ Time Frame: 7 years ]
• Number of technical difficulties encountered with the device [ Time Frame: 7 years ]

Original Secondary Outcome Measures (submitted: March 19, 2019)

• Length of hospital stay for primary (index) surgery [ Time Frame: 7 years ]
• Number of hospitalizations (admission for inpatient care) occurring after the hospitalization for the index surgery [ Time Frame: 7 years ]
• Length of stay of hospitalizations (admission for inpatient care) occurring after the hospitalization for the index surgery [ Time Frame: upon occurence through 7 years of study duration ]
• Number of rehabilitation sessions [ Time Frame: 7 years ]
• Duration of rehabilitation sessions in weeks [ Time Frame: upon occurence through 7 years of study duration ]
• Number and type of outpatient visits [ Time Frame: 7 years ]
• Number of re-operations [ Time Frame: 7 years ]
• Quality of Life as measured by EQ-5D-3L score [ Time Frame: 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) [ Time Frame: 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.
• Number of days before return to work [ Time Frame: 7 years ]
• Number of technical difficulties encountered with the device [ Time Frame: 7 years ]

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Safety and Performance of JOURNEY™ II Cruciate Retaining (CR) Total Knee System (TKS)
• Official Title: Safety and Performance of JOURNEY™ II Cruciate Retaining (CR) Total Knee System (TKS): A Retrospective, Multicenter Study
• 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 Provided
• Study Type: Observational
• Study Design: Observational Model: Case-Only; Time Perspective: Retrospective
• Target Follow-Up Duration: Not Provided
• Biospecimen: Not Provided
• Sampling Method: Non-Probability Sample
• Study Population: Rheumatoid arthritis; post-traumatic arthritis, osteoarthritis or degenerative arthritis; failed osteotomies or unicompartmental replacement. This system is designed for use in patients having primary total knee replacement surgery, where the cruciate ligaments and the collateral ligaments remain intact.
• Condition: Journey II CR Total Knee System

Intervention

Device: Total knee arthroplasty with Journey II CR Total Knee System

TKA with Journey II CR Total Knee System

• Study Groups/Cohorts: Not Provided
• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: June 19, 2019): 600
• Original Estimated Enrollment (submitted: March 19, 2019): 300
• Estimated Study Completion Date: September 30, 2020
• Estimated Primary Completion Date: July 31, 2020 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: Child, Adult, Older Adult
• Accepts Healthy Volunteers: Not Provided

Contacts

Contact: Sandra Navarrete; 512-579-1395; Sandra.navarrete@smith-nephew.com

• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT03885531
• Other Study ID Numbers: 2018.19.KNE.JIICR.RET
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No

• Responsible Party: Smith & Nephew, Inc.
• Study Sponsor: Smith & Nephew, Inc.
• Collaborators: Nor Consult

Investigators

• Study Chair: Sandra Navarrete; Smith & Nephew, Inc.
• Principal Investigator: Sanjai Shukla, MD; Reno Orthopedic Clinic

• PRS Account: Smith & Nephew, Inc.
• Verification Date: May 2020