Clinical trial NCT03060057: 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"
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Osteo Arthritis Knee
Lead sponsor: United Orthopedic Corporation
Sponsor class: INDUSTRY
First posted: 2017-02-23
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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.

Primary outcomes:
measure: Implant Survivorship
timeFrame: 2 Years
Secondary outcomes:
measure: Change in Knee Society Score (KSS) Over Time
timeFrame: Baseline, 6 weeks, 3 months, 6 months, 12 months, 24 months, 3 years, 4 years, 5 years
measure: Change in EQ-5D Over Time
timeFrame: Baseline, 6 weeks, 3 months, 6 months, 12 months, 24 months, 3 years, 4 years, 5 years
measure: Change in EQ-5D VAS Over Time
timeFrame: Baseline, 6 weeks, 3 months, 6 months, 12 months, 24 months, 3 years, 4 years, 5 years
measure: Change in KOOS, JR. Over Time
timeFrame: Baseline, 6 weeks, 3 months, 6 months, 12 months, 24 months, 3 years, 4 years, 5 years
measure: Radiographic Analysis
timeFrame: 24 months, 5 years
measure: Operative characteristics
timeFrame: Operative
measure: Subject Satisfaction Survey
timeFrame: 6 weeks, 3 months, 6 months, 12 months, 2 Years, 3 Years, 4 Years and 5 Years.
Other outcomes:
Locations:
city: Bradenton
country: United States
facility: Coastal Orthopedics
state: Florida
city: Jacksonville
country: United States
facility: Jacksonville Orthopaedic Institute
state: Florida
city: Vero Beach
country: United States
facility: Orthopedic Center of Vero Beach
state: Florida
city: Baltimore
country: United States
facility: Rubin Institute for Advanced Orthopedics
state: Maryland
Study officials:
References: