United Orthopedic (UOC) launched "Prospective Post Approval Clinical Follow-Up Study of the Commercially Available U2 Knee™ System – 'U Propel Study'," and enrolled its first patient. The prospective, single arm, multi-center, postmarket study will evaluate short- and long-term clinical performance and implant survivorship of the U2 Knee in primary total knee arthroplasty.
U-Propel will enroll up to 200 patients with follow-up out to five years. Outcomes will be analyzed and published in three phases: after six-week follow-up; two-year follow-up and at conclusion of the study. On clinicaltrials.gov, the study's identifier is NCT03060057.
UOC is also conducting a U.S. follow-up study of its U-Motion II+ Acetabular System and UTF Reduced Stem in primary total hip arthroplasty patients. Estimated primary completion for that study is January 2019.
Source: United Orthopedic Corporation