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H1 Hip Resurfacing Arthroplasty
Sponsor: Embody Orthopaedic Limited
Summary
This is a prospective, non-randomized, consecutive series, multicentre, observational study to evaluate the clinical outcome of ceramic-on- ceramic hip resurfacing arthroplasty using the ceramic, non-porous, non-cemented H1 Hip Resurfacing Arthroplasty. It includes a safety study followed by an efficacy study. Patients will be followed up for 10-years postoperatively. The primary aim is to confirm the safety of the H1 hip resurfacing prosthesis by demonstrating non-inferiority of the H1 device in terms of survivorship. The secondary is to evaluate superiority of the ceramic-on-ceramic H1 hip resurfacing prosthesis compared to Metal-on-Metal (MoM) hip resurfacing in terms of absence of metal ion release.The primary end point is revision for any reason.
Official title: A Prospective, Non-randomized, Consecutive Series, Multicentre, Observational Study to Evaluate the Clinical Outcome of ceramic-on- Ceramic Hip Resurfacing Arthroplasty Using the Ceramic, Non-porous, Non-cemented H1 Hip Resurfacing Arthroplasty
Key Details
Gender
All
Age Range
18 Years - 70 Years
Study Type
OBSERVATIONAL
Enrollment
250
Start Date
2017-09-26
Completion Date
2033-03-25
Last Updated
2023-09-07
Healthy Volunteers
No
Interventions
H1 Hip Resurfacing Arthroplasty
A non-porous non-cemented ceramic-on-ceramic hip resurfacing arthroplasty device
Locations (2)
Charing Cross Hospital
London, United Kingdom
Kind Edward VII's Hospital
London, United Kingdom