To evaluate the clinical outcome of a ceramic-on-ceramic hip resurfacing arthroplasty using the ceramic, non-porous, non-cemented H1 Hip Resurfacing Arthroplasty

Not Applicable

• Conditions: Hip arthroplasty; Surgery

• Registration Number: ISRCTN91554748
• Lead Sponsor: Embody Orthopaedic Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-12-09
• Last Update Posted: 10 January 2022
• Study Completion: 2032-09-26

Recruitment & Eligibility

• Status: Ongoing
• Sex: All
• Target Recruitment: 250

Inclusion Criteria

1. Patient requires primary hip arthroplasty due to degenerative joint disease (primary osteoarthritis, posttraumatic osteoarthritis, avascular necrosis, developmental hip dysplasia)
2. Patients femoral bone stock is adequate for hip resurfacing on plain radiographs
3. Patient is between 18 and 70 years old
4. Patient willing to comply with study requirements
5. Patient plans to be available through 10 years postoperative follow-up
6. Patient is able to understand the native language of the country where their procedure is taking place.

Exclusion Criteria

1. Patient has a BMI greater than 40 kg/m²
2. Patient suffers from an active inflammatory joint disorder
3. Patient has an active infection or sepsis (treated or untreated)
4. Patient has insufficient bone stock at the hip (>1/3 necrosis of the femoral head)
5. Patient has severe osteopenia or osteoporosis, defined using DXA by T-score of <-2.5 (if T-score does not meet the criteria, please confirm with coordinating site (ICL) for participant eligibility)
6. Patient has large and multiple cysts in the femoral head (patients with cysts to be reviewed by coordinating site (ICL) for participant eligibility)
7. At the time of enrolment, patient has one or more of the following arthroplasties that have been implanted less than 6 months before the current hip arthroplasty:
7.1. Contralateral primary total hip arthroplasty or hip resurfacing arthroplasty
7.2. Ipsilateral or contralateral primary total knee or unicondylar knee arthroplasty
8. Patient takes medications which potentially affect the bone such as corticosteroids and antimitotic medications
9. Patient has a condition that may interfere with the hip arthroplasty survival or outcome (i.e., Paget’s or Charcot’s disease, vascular insufficiency, muscular atrophy, uncontrolled diabetes, moderate to severe renal insufficiency or neuromuscular disease)
10. Patient has a known alcohol or drug abuse
11. Patient has an immunosuppressive disorder
12. Patient has a malignant tumour, metastatic, or neoplastic disease
13. Patient has severe comorbidities or a limited life expectancy
14. Patient lacks capacity to consent
15. Patient has an emotional or neurological condition that would pre-empt his/her ability or willingness to participate in the study
16. Patient is not willing or able to sign an informed consent form
17. Patient pregnant or breast feeding
18. Patient is not able or willing to come to follow-up visits
19. Any other clinical reason, which the investigator considers would make the patient unsuitable for the trial
20. Implant size unavailable

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br> 1. The efficacy of the implant shall be measured by Implant survivorship (defined as 98.6% cumulative survivorship without revision for any reason at 1 year, 97.6% survivorship at 3 years, 96.5% survivorship at 5 years and 93% survivorship at 10 years)<br> At 6 weeks, 6 months, 1 year, 2 years, 3 years, 5 years, 7 years and 10 years:<br> 2. Hip function will be measured by the Oxford Hip Score and the Imperial Hip Score<br> 3. Quality of life shall be measured by the EQ5D score<br> 4. Mobility and hip function shall be measured by the Harris Hip Score<br> 5. Implant orientation and stability shall be measured by X-rays<br>

Secondary Outcome Measures

Name	Time	Method
<br> 1. Safety of the implant shall be measured by the number of adverse events and revisions throughout the study taken from patient records<br> 2. Safety of the implant in terms of toxicology shall be measured by blood metal ion levels and compared to MHRA action levels using blood tests (when taken) at 3, 6, 12 and 24 months<br> 3. Implant stability in terms of migration shall be measured by CT assessment at 6 weeks, 3, 6, 9, 12 and 24 months<br>