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ACTIVE NOT RECRUITING
NCT03326804

H1 Hip Resurfacing Arthroplasty

Sponsor: Embody Orthopaedic Limited

View on ClinicalTrials.gov

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

DEVICE

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