Orthopedic device company United Orthopedic Corporation (UOC), has started patient enrollment in a follow-up study in the U.S. of its commercially available U-Motion II+ Acetabular System and UTF Reduced Stem in patients receiving primary total hip arthroplasty (THA).
Background
The prospective, single arm, multi-center, post-approval study is designed to evaluate the short and long-term clinical performance of the devices, which are designed to improve hip flexion, reduce the risk of joint dislocation and allow for minimal bone removal during THA procedures.
UOC dedicates its efforts to providing advanced solutions for joint treatment as the U.S. population ages and demand increases for improved technologies and procedures. Its U-Motion II+ Acetabular System utilizes a unique coating technology intended to achieve a greater surface roughness of the implant. This allows for better initial stability and has been shown to reduce micromotion, both of which contribute to the long term fixation of the implant. The UTF Reduced Stem, forged from titanium alloy, is a wedge-shaped stem that facilitates optimal placement and fit in femora of varying disphyseal and metaphyseal widths. It comes in 14 sizes, with standard and high offset options, and key sizes (ranging from 3 to 8) with 1mm increments. The stem features optimized neck geometry, which contributes to increased range of motion and decreased cup-neck impingement.
The primary objectives of the new study include operative success, hip function at two-year follow up as measured by the Harris Hip Score (HHS) and device survivorship. Patients will be evaluated at predetermined intervals up to five years for device survivorship. The estimated study duration from first enrollment through completion of the final report is expected to be approximately seven years.
Kurtis Biggs, DO, founder of the Joint Replacement Institute in Naples, Florida, implanted the first U-Motion II+ Acetabular System and UTF Reduced Stem on a patient enrolled in the study on January 20, 2016 using the direct anterior approach, a minimally invasive, tissue-sparing technique that allows for quicker recovery and improved outcomes for patients. UOC plans to enroll up to 200 patients at a maximum of five sites in the U.S.
Physician comments
Dr. Biggs stated; “Despite numerous advances in hip replacement technology, issues such as postoperative dislocation, bearing wear and insufficient range of motion remain challenging problems, especially for younger, more active individuals.”
“The U-Motion II+ Acetabular System and UTF Reduced Stem are designed to address these issues by using enhanced implant materials, which allow for improved hip flexion and less risk of joint dislocation. We plan to investigate the clinical performance of the devices to further establish its benefit for patients seeking relief of hip pain or improved hip function.”
Company comments
“This is an important milestone for United Orthopedic Corporation as we continue to establish our presence in the United States and provide life-changing technologies to address an unmet need in patients seeking a long-term solution for severe hip pain,” said Calvin Lin, President of UOC USA, a subsidiary of UOC located in Irvine, CA. “For over two decades, UOC has offered meaningful orthopedic solutions to practitioners and institutions that improve patient care.”
Source: PR Newswire
published: February 24, 2016 in: Clinical Studies/Trials, Hip