Post Approval Study of the Commercially Available U-Motion II+ Acetabular System and UTF Reduced Stem

Status unconfirmed

Conditions studied: Osteoarthritis

In brief

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 hip arthroplasty (THA) with the U-Motion II+ Acetabular System and UTF Reduced Stem.

Key facts

Study ID: NCT02761499
Run by: United Orthopedic Corporation
People needed: 200
Starts: 2016-01-01
Expected to finish: 2025-08-01
Last updated by the study team: 2023-06-05

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Subjects must meet all of the following criteria to be considered for inclusion in the study.
Subject is between 18 and 75 years of age
Subject is indicated for a unilateral or bilateral total hip arthroplasty (THA) based on the approved labeling of the device
Subject has no history of previous prosthetic replacement device or orthopedic surgeries on the operative hip
Subject is willing and able to provide informed consent to participate in the study;
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;

You may not qualify if…

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.

Where it is running

Jacksonville Orthopaedic Institute — Jacksonville, Florida, United States
Joint Replacement Institute — Naples, Florida, United States
Hospital for Special Surgery — New York, New York, United States
Ortho Dayton — Dayton, Ohio, United States
Penn Orthopaedics — Philadelphia, Pennsylvania, United States
Kenosha Orthopedics — Kenosha, Wisconsin, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.