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NCT03326804 · ClinicalTrials.gov record · last posted 2026-08-13

H1 Hip Resurfacing Arthroplasty

Study acronym: H1HRA
StatusActive, Not Recruiting
PhaseNot specified
Started2017-09-26
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from the ClinicalTrials.gov record
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.

Protocol amendment history 1 change detected by DataLookout

2026-08-14
Primary completion moved earlier: 2032-09-25 → 2032-03-17
Trial Details
NCT Number NCT03326804
Lead Sponsor Embody Orthopaedic Limited
Collaborators: Imperial College London
Conditions Hip Osteoarthritis, Hip Necrosis, Hip Dysplasia
Enrollment 250 participants
Start Date 2017-09-26
Primary Completion 2032-03-17 (estimated)
Study Completion 2033-03-25 (estimated)
Updated on ClinicalTrials.gov 2026-08-13