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

• ClinicalTrials.gov Identifier: NCT03060057
• Recruitment Status: Active, not recruiting
• First Posted: February 23, 2017
• Last Update Posted: October 26, 2021
• Sponsor: United Orthopedic Corporation
• Information provided by (Responsible Party): United Orthopedic Corporation

Study Description

Brief 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.

Condition or disease	Intervention/treatment
Osteo Arthritis Knee	Device: U2 Knee™ System

Detailed 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.

Study Design

• Study Type: Observational
• Actual Enrollment: 200 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• 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

Groups and Cohorts

Intervention Details:

• 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.

Outcome Measures

Primary Outcome Measures :

1. Implant Survivorship [ Time Frame: 2 Years ]
   Device Survivorship defined as no revision of removal of any parts of the system

Secondary Outcome Measures :

1. 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
2. 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.
3. 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.
4. 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.
5. Radiographic Analysis [ Time Frame: 24 months, 5 years ]
   This endpoint is defined as incidence rate of new radiographic failures at each follow-up visit.
6. Operative characteristics [ Time Frame: Operative ]
   Descriptive statistics in operative characteristics will be reported as secondary endpoints to evaluate operative success
7. 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.

Eligibility Criteria

• 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

Study Population

The U2 Knee™ System is intended for use in subjects who require primary total knee arthroplasty for reduction or relief of pain and/or improved knee function.

Criteria

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.

Contacts and Locations

Locations

United States, Florida

Coastal Orthopedics

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

Sponsors and Collaborators

United Orthopedic Corporation

More Information

• Responsible Party: United Orthopedic Corporation
• ClinicalTrials.gov Identifier: NCT03060057
• Other Study ID Numbers: 03-2017
• First Posted: February 23, 2017
• 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

Additional relevant MeSH terms:

Osteoarthritis; Osteoarthritis, Knee; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases