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

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ClinicalTrials.gov Identifier: NCT03885531
Recruitment Status : Recruiting
First Posted : March 21, 2019
Last Update Posted : May 5, 2020
Sponsor:
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
Change History
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

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
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
Removed Location Countries  
 
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