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

Tracking Information

• First Submitted Date: February 10, 2017
• First Posted Date: February 23, 2017
• Last Update Posted Date: October 26, 2021
• Actual Study Start Date: March 30, 2017
• Estimated Primary Completion Date: March 30, 2024 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: February 16, 2017)

Implant Survivorship [ Time Frame: 2 Years ]

Device Survivorship defined as no revision of removal of any parts of the system

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: February 16, 2017)

• 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.

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Prospective Post Approval Clinical Follow-Up Study of the Commercially Available U2 Knee™ System - "U-Propel Study"
• Official Title: Prospective Post Approval Clinical Follow-Up Study of the Commercially Available U2 Knee™ System - "U-Propel Study"
• 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.

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 Type: Observational
• Study Design: Observational Model: Cohort; Time Perspective: Prospective
• Target Follow-Up Duration: Not Provided
• Biospecimen: Not Provided
• 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.
• Condition: Osteo Arthritis 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.

• Study Groups/Cohorts: Not Provided
• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Active, not recruiting
• Actual Enrollment (submitted: February 16, 2017): 200
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: March 30, 2026
• Estimated Primary Completion Date: March 30, 2024 (Final data collection date for primary outcome measure)

Eligibility 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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 75 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT03060057
• Other Study ID Numbers: 03-2017
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• 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

IPD Sharing Statement

• Plan to Share IPD: Undecided

• Current Responsible Party: United Orthopedic Corporation
• Original Responsible Party: Same as current
• Current Study Sponsor: United Orthopedic Corporation
• Original Study Sponsor: Same as current
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: United Orthopedic Corporation
• Verification Date: October 2021