Prospective Post Approval Clinical Follow-Up Study of the Commercially Available U2 Knee™ System - "U-Propel Study" (U-Propel)
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|ClinicalTrials.gov Identifier: NCT03060057|
Recruitment Status : Active, not recruiting
First Posted : February 23, 2017
Last Update Posted : October 26, 2021
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|Condition or disease||Intervention/treatment|
|Osteo Arthritis Knee||Device: U2 Knee™ System|
This is a prospective, single arm, multi-center, post-approval study designed to evaluate the short and long term clinical performance and safety in subjects receiving primary total knee arthroplasty (TKA) with the U2 Knee™ System. The study will enroll up to 200 subjects with scheduled pre-discharge, 6-week, 3- and 6-month and up to 5-year annual follow-up visits. Study outcomes will be analyzed and published when 1.) all enrolled and implanted subjects complete their 6-week follow up, 2.) all implanted subjects complete their 2-year follow up, 3.) at the conclusion of the study.
The study will follow GCP guidelines and will be registered on clinicaltrials.gov.
|Study Type :||Observational|
|Actual Enrollment :||200 participants|
|Official Title:||Prospective Post Approval Clinical Follow-Up Study of the Commercially Available U2 Knee™ System - "U-Propel Study"|
|Actual Study Start Date :||March 30, 2017|
|Estimated Primary Completion Date :||March 30, 2024|
|Estimated Study Completion Date :||March 30, 2026|
- Device: U2 Knee™ System
The United U2 Knee™ System consists of several components and for this clinical evaluation it includes the (1) Femoral Component, (2) Tibial Insert, 3) Tibial Baseplate, and the 4) Patella.
- Implant Survivorship [ Time Frame: 2 Years ]Device Survivorship defined as no revision of removal of any parts of the system
- Change in Knee Society Score (KSS) Over Time [ Time Frame: Baseline, 6 weeks, 3 months, 6 months, 12 months, 24 months, 3 years, 4 years, 5 years ]This endpoint is defined as differences in both pain and functional parameters measured at current and pre-discharge visits
- Change in EQ-5D Over Time [ Time Frame: Baseline, 6 weeks, 3 months, 6 months, 12 months, 24 months, 3 years, 4 years, 5 years ]This endpoint is defined as differences in scores related to the EQ-5D questionnaire and the EQ-VAS measured at current and pre-discharge visits.
- Change in EQ-5D VAS Over Time [ Time Frame: Baseline, 6 weeks, 3 months, 6 months, 12 months, 24 months, 3 years, 4 years, 5 years ]This endpoint is defined as differences in scores related to the EQ-5D VAS questionnaire and the EQ-VAS measured at current and pre-discharge visits.
- Change in KOOS, JR. Over Time [ Time Frame: Baseline, 6 weeks, 3 months, 6 months, 12 months, 24 months, 3 years, 4 years, 5 years ]This endpoint is defined as difference in the KOOS, Jr interval score measured at current and pre-discharge visits.
- Radiographic Analysis [ Time Frame: 24 months, 5 years ]This endpoint is defined as incidence rate of new radiographic failures at each follow-up visit.
- Operative characteristics [ Time Frame: Operative ]Descriptive statistics in operative characteristics will be reported as secondary endpoints to evaluate operative success
- Subject Satisfaction Survey [ Time Frame: 6 weeks, 3 months, 6 months, 12 months, 2 Years, 3 Years, 4 Years and 5 Years. ]Subject satisfaction with their knee surgery.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
|Ages Eligible for Study:||18 Years to 75 Years (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
|Sampling Method:||Non-Probability Sample|
- Subject is between 18 and 75 years of age
- Subject is indicated for a unilateral total knee arthroplasty (TKA) based on the approved labeling of the device
- Subject has no history of previous prosthetic replacement device or orthopedic surgeries on the operative knee
- Subject is willing and able to provide informed consent to participate in the study;
- Subject is willing and able to understand the purpose of the study, his/her role, and is available to return to the clinic/hospital for all required follow-up visits;
- Subjects will be excluded if, in the opinion of the Investigator, the subject does not qualify based on approved labeling requirements or Subject Inclusion criteria.
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): NCT03060057
|United States, Florida|
|Bradenton, Florida, United States, 34209|
|Jacksonville Orthopaedic Institute|
|Jacksonville, Florida, United States, 32204|
|Orthopedic Center of Vero Beach|
|Vero Beach, Florida, United States, 32960|
|United States, Maryland|
|Rubin Institute for Advanced Orthopedics|
|Baltimore, Maryland, United States, 21215|
|Responsible Party:||United Orthopedic Corporation|
|Other Study ID Numbers:||
|First Posted:||February 23, 2017 Key Record Dates|
|Last Update Posted:||October 26, 2021|
|Last Verified:||October 2021|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||Undecided|
|Studies a U.S. FDA-regulated Drug Product:||No|
|Studies a U.S. FDA-regulated Device Product:||Yes|
|Product Manufactured in and Exported from the U.S.:||No|