Vivacit-E Post-market Follow-up Study
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03226808|
Recruitment Status : Active, not recruiting
First Posted : July 24, 2017
Last Update Posted : May 3, 2022
|Condition or disease||Intervention/treatment||Phase|
|Osteoarthritis Avascular Necrosis of Bone of Hip Post-traumatic; Arthrosis Congenital Hip Dysplasia||Device: Vivacit-E Liner||Not Applicable|
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 (Clinical Trial)|
|Actual Enrollment :||258 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Post Market Clinical Follow-up Study of the Zimmer Vivacit-E Highly Crosslinked Polyethylene Liner Used With the Continuum Acetabular Shell|
|Actual Study Start Date :||October 1, 2013|
|Estimated Primary Completion Date :||March 2, 2026|
|Estimated Study Completion Date :||June 30, 2028|
All subjects enrolled receive the study implant.
Device: Vivacit-E Liner
All subjects enrolled will receive the Vivacit-E liner.
- Survival of the study device; whether or not it is still implanted in the subject [ Time Frame: 10 years ]Survival is classified as removal of the study device for any reason
- Incidence of treatment-emergent Adverse Events (safety) [ Time Frame: 10 years ]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.
- Harris Hip Score [ Time Frame: 10 years ]Functional outcomes are measured with the Harris Hip Score, including range of motion, pain level, activity levels and patient satisfaction.
- Patient activity level [ Time Frame: 10 years ]Patient activity level is assessed with the High Activity Arthroplasty score, filled out by the patient.
- Patient Quality of Life [ Time Frame: 10 years ]This is another self-assessment by means of the EQ-5D score, which measures the patient's perceived quality of life.
- Radiographic analysis [ Time Frame: 2 years ]Patient x-rays will undergo a Martell analysis by Dr. John Martell to evaluate radiolucencies, osteolysis, sbusidence, cup migration and polyethylene wear.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03226808
|United States, Colorado|
|Denver Hip and Knee, Inc.|
|Parker, Colorado, United States, 80134|
|United States, North Carolina|
|Department of Orthopaedics University of North Carolina at Chapel Hill|
|Chapel Hill, North Carolina, United States, 27599|
|OrthoCarolina Research Institute|
|Charlotte, North Carolina, United States, 28207|
|United States, Pennsylvania|
|Philadelphia, Pennsylvania, United States, 19107|
|United States, Texas|
|Texas Institute for Hip and Knee Surgery|
|Austin, Texas, United States, 78751|
|Study Director:||Ryan Boylan, MBA||Zimmer Biomet|