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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03885531
Recruitment Status : Recruiting
First Posted : March 21, 2019
Last Update Posted : June 21, 2019
Sponsor:
Collaborator:
Nor Consult
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment
Journey II CR Total Knee System Device: Total knee arthroplasty with Journey II CR Total Knee System

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Study Type : Observational
Estimated Enrollment : 600 participants
Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: Safety and Performance of JOURNEYTM II Cruciate Retaining (CR) Total Knee System (TKS): A Retrospective, Multicenter Study
Actual Study Start Date : March 27, 2019
Estimated Primary Completion Date : January 2020
Estimated Study Completion Date : January 2020

Intervention Details:
  • Device: Total knee arthroplasty with Journey II CR Total Knee System
    TKA with Journey II CR Total Knee System


Primary Outcome Measures :
  1. Number of adverse events reported per ISO 14155 guidelines [ Time Frame: 7 years ]

Secondary Outcome Measures :
  1. Length of hospital stay for primary (index) surgery [ Time Frame: 7 years ]
  2. Number of hospitalizations (admission for inpatient care) occurring after the hospitalization for the index surgery [ Time Frame: 7 years ]
  3. 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 ]
  4. Number of rehabilitation sessions [ Time Frame: 7 years ]
  5. Duration of rehabilitation sessions in weeks [ Time Frame: 7 years ]
  6. Number and type of outpatient visits [ Time Frame: 7 years ]
  7. Number of re-operations [ Time Frame: 7 years ]
  8. 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.

  9. 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.

  10. Number of days before return to work [ Time Frame: 7 years ]
  11. Number of technical difficulties encountered with the device [ Time Frame: 7 years ]


Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
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.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03885531


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

Locations
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United States, Ohio
OrthoNeuro Recruiting
New Albany, Ohio, United States, 43054
Contact: Mark Edwards Gittins, DO         
Principal Investigator: Mark Edwards Gittins, DO         
Sponsors and Collaborators
Smith & Nephew, Inc.
Nor Consult

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Responsible Party: Smith & Nephew, Inc.
ClinicalTrials.gov Identifier: NCT03885531     History of Changes
Other Study ID Numbers: 2018.19.KNE.JIICR.RET
First Posted: March 21, 2019    Key Record Dates
Last Update Posted: June 21, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Smith & Nephew, Inc.:
Journey II CR Total Knee System