The objectives of this study are to obtain clinical performance (outcomes) data and survivorship for commercially available Vivacit-E (HXPE) liners. This will be done by analysis of polyethylene wear, validated outcome measurement tools, radiographs, and reported adverse events data.
Safety will be evaluated by monitoring the frequency and incidence of adverse events. Performance will be determined by assessment of the overall pain and functional performances, survivorship, health status and radiographic parameters of all enrolled study subjects who receive the Vivacit-E HXPE Liner with the Continuum acetabular shell. In addition, the implanted Vivacit-E HXPE Liners will be evaluated for bedding in, and linear and volumetric wear by the Martell 2-D method at 6 weeks and 1, 2, 4, \& 5 years postoperatively. Pain and functional performance will be measured using the Harris Hip and High Activity Arthroplasty Scores. Survivorship will be based on removal or intended removal of the device and through analysis of radiographs, and health status will be determined by evaluation of the EQ-5D.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
258
All subjects enrolled will receive the Vivacit-E liner.
Denver Hip and Knee, Inc.
Parker, Colorado, United States
Department of Orthopaedics University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States
OrthoCarolina Research Institute
Charlotte, North Carolina, United States
Rothman Institute
Philadelphia, Pennsylvania, United States
Survival of the study device; whether or not it is still implanted in the subject
Survival is classified as removal of the study device for any reason
Time frame: 10 years
Incidence of treatment-emergent Adverse Events (safety)
Safety is assessed by monitoring the frequency and incidence of all adverse events, with particular focus on those that may be related to the study device.
Time frame: 10 years
Harris Hip Score
Functional outcomes are measured with the Harris Hip Score, including range of motion, pain level, activity levels and patient satisfaction.
Time frame: 10 years
Patient activity level
Patient activity level is assessed with the High Activity Arthroplasty score, filled out by the patient.
Time frame: 10 years
Patient Quality of Life
This is another self-assessment by means of the EQ-5D score, which measures the patient's perceived quality of life.
Time frame: 10 years
Radiographic analysis
Patient x-rays will undergo a Martell analysis by Dr. John Martell to evaluate radiolucencies, osteolysis, sbusidence, cup migration and polyethylene wear.
Time frame: 2 years
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Texas Institute for Hip and Knee Surgery
Austin, Texas, United States