Prospective Post Approval Clinical Follow-Up Study of the Commercially Available U2 Knee™ System - "U-Propel Study" (U-Propel)
|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: NCT03060057|
Recruitment Status : Recruiting
First Posted : February 23, 2017
Last Update Posted : November 17, 2020
|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|
|Estimated 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, 2022|
|Estimated Study Completion Date :||March 30, 2024|
- 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.
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
|Contact: Mindy Carlsonfirstname.lastname@example.org|
|United States, Florida|
|Bradenton, Florida, United States, 34209|
|Contact: Christine Scheuerman, RN, BSN 941-782-1353 ext 3450 email@example.com|
|Principal Investigator: David Cashen, MD|
|Sub-Investigator: Alan Valadie, MD|
|Sub-Investigator: Arthur Valadie, MD|
|Sub-Investigator: Daniel Lamar, MD|
|Jacksonville Orthopaedic Institute||Recruiting|
|Jacksonville, Florida, United States, 32204|
|Contact: Carol Collins 904-388-1400|
|Principal Investigator: Stanton Longenecker, MD|
|Orthopedic Center of Vero Beach||Recruiting|
|Vero Beach, Florida, United States, 32960|
|Contact: Nicki Allen 772-778-2009|
|Principal Investigator: Richard Steinfeld, MD|
|United States, Maryland|
|Rubin Institute for Advanced Orthopedics||Recruiting|
|Baltimore, Maryland, United States, 21215|
|Contact: Ashwin Mahajan 410-601-8500|
|Sub-Investigator: Ronald Delanois, MD|
|Principal Investigator: James Nace, MD|