MedTrace Logo

H1 Hip Resurfacing Arthroplasty

NCT03326804 · Status: ACTIVE_NOT_RECRUITING · Type: OBSERVATIONAL · Enrollment: 250

Last updated 2023-09-07

No results posted yet for this study

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.

Conditions

  • Hip Osteoarthritis
  • Hip Necrosis
  • Hip Dysplasia

Interventions

DEVICE

H1 Hip Resurfacing Arthroplasty

A non-porous non-cemented ceramic-on-ceramic hip resurfacing arthroplasty device

Sponsors & Collaborators

  • Imperial College London

    collaborator OTHER

  • Embody Orthopaedic Limited

    lead INDUSTRY

Principal Investigators

  • Justin P Cobb, FRCS · Imperial College London

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-09-26
Primary Completion
2032-09-25
Completion
2033-03-25

Countries

  • United Kingdom

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03326804 on ClinicalTrials.gov