Actively Recruiting
Post Market Clinical Follow-up Study of Everglade Stem, World Acetabular Cup, and World Liner Assessing Safety and Performance in Primary Total Hip Replacement up to 2 Years
Led by Signature Orthopaedics · Updated on 2023-12-01
200
Participants Needed
1
Research Sites
N/A
Total Duration
AI-Summary
What this Trial Is About
This research aims to monitor the performance and safety of the Everglade Stem, World Acetabular Cup, and World Liner devices used in primary total hip arthroplasty for patients with hip disease. These devices are recently introduced to the market, and the study collects data to confirm their safety, performance, and clinical benefits over a two-year follow-up period. Participants will receive the Everglade Stem, a cementless titanium hip stem with a special coating for bone growth, along with the World Acetabular Cup and World Liner, designed to work together for hip replacement. The study gathers information starting before surgery, at discharge, and at 1-year and 2-year post-operative visits to evaluate device performance and safety. During the study, participants will undergo assessments including measurement of the revision rate of the implants, patient-reported outcomes using the Oxford Hip Score to assess satisfaction, and radiographic analysis to observe bone response to the implants. The total monitoring period is two years, with data collected at several specific time points to evaluate the devices survival and effectiveness.
CONDITIONS
Brief Title
Everglade Stem, World Cup and World Liner Post Market Clinical Follow-up
Research Team
S
Satish A Shejale, M.S. Orthopaedics
D
Declan Brazil, PhD
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