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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT03326804
Other study ID # 213102
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date September 26, 2017
Est. completion date March 25, 2033

Study information

Verified date September 2023
Source Embody Orthopaedic Limited
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Description:

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Study Design


Related Conditions & MeSH terms


Intervention

Device:
H1 Hip Resurfacing Arthroplasty
A non-porous non-cemented ceramic-on-ceramic hip resurfacing arthroplasty device

Locations

Country Name City State
United Kingdom Charing Cross Hospital London
United Kingdom Kind Edward VII's Hospital London

Sponsors (2)

Lead Sponsor Collaborator
Embody Orthopaedic Limited Imperial College London

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Oxford Hip Score Hip Specific Patient Reported Outcome Measure (PROM) 10 years
Primary EQ-5D Health-Related Quality of Life Questionnaire Generic Patient Reported Outcome Measure (PROM) 10 years
Secondary Complication Rate Adverse Events and revisions 10 years
Secondary Clinical objective outcome measures Harris Hip Score 10 years
Secondary Acetabular Implant orientation Evaluation of AP and Lateral Hip Radiographs, measured in degrees 10 years
Secondary Femoral Implant orientation Evaluation of AP and Lateral Hip Radiographs, measured in degrees 10 years
Secondary Low-dose CT CT to evaluate component migration and bone ingrowth (Safety study - Cohort 1 - 20 patients) Up till 2 years
Secondary Metal ion measurements Concentration of metal ions in patient's blood (Safety study - Cohort 1 - 20 patients) Up till 2 years
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