Prospective Post Approval Clinical Follow-Up Study of the Commercially Available U2 Knee™ System - "U-Propel Study"

Osteo Arthritis Knee Clinical Trial

— U-Propel  

Official title:

Prospective Post Approval Clinical Follow-Up Study of the Commercially Available U2 Knee™ System - "U-Propel Study"

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03060057
• Other study ID #: 03-2017
• Status: Active, not recruiting
• Start date: March 30, 2017
• Est. completion date: March 30, 2026

Study information

• Verified date: June 2023
• Source: United Orthopedic Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The purpose of this study is to evaluate both short and long term clinical performance and safety of the commercially available U2 Knee™ System.

Description:

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 200
• Est. completion date: March 30, 2026
• Est. primary completion date: March 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

1. Subject is between 18 and 75 years of age

2. Subject is indicated for a unilateral total knee arthroplasty (TKA) based on the approved labeling of the device

3. Subject has no history of previous prosthetic replacement device or orthopedic surgeries on the operative knee

4. Subject is willing and able to provide informed consent to participate in the study;

5. 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;

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Osteo Arthritis Knee
• Osteoarthritis
• Osteoarthritis, Knee

Intervention

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.

Locations

Country	Name	City	State
United States	Rubin Institute for Advanced Orthopedics	Baltimore	Maryland
United States	Coastal Orthopedics	Bradenton	Florida
United States	Jacksonville Orthopaedic Institute	Jacksonville	Florida
United States	Orthopedic Center of Vero Beach	Vero Beach	Florida

Sponsors (1)

Lead Sponsor	Collaborator
United Orthopedic Corporation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Implant Survivorship	Device Survivorship defined as no revision of removal of any parts of the system	2 Years
Secondary	Change in Knee Society Score (KSS) Over Time	This endpoint is defined as differences in both pain and functional parameters measured at current and pre-discharge visits	Baseline, 6 weeks, 3 months, 6 months, 12 months, 24 months, 3 years, 4 years, 5 years
Secondary	Change in EQ-5D Over Time	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.	Baseline, 6 weeks, 3 months, 6 months, 12 months, 24 months, 3 years, 4 years, 5 years
Secondary	Change in EQ-5D VAS Over Time	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.	Baseline, 6 weeks, 3 months, 6 months, 12 months, 24 months, 3 years, 4 years, 5 years
Secondary	Change in KOOS, JR. Over Time	This endpoint is defined as difference in the KOOS, Jr interval score measured at current and pre-discharge visits.	Baseline, 6 weeks, 3 months, 6 months, 12 months, 24 months, 3 years, 4 years, 5 years
Secondary	Radiographic Analysis	This endpoint is defined as incidence rate of new radiographic failures at each follow-up visit.	24 months, 5 years
Secondary	Operative characteristics	Descriptive statistics in operative characteristics will be reported as secondary endpoints to evaluate operative success	Operative
Secondary	Subject Satisfaction Survey	Subject satisfaction with their knee surgery.	6 weeks, 3 months, 6 months, 12 months, 2 Years, 3 Years, 4 Years and 5 Years.