ISRCTN91554748
Active, not recruiting
未知
H1 Hip Resurfacing Arthroplasty
Overview
- Phase
- 未知
- Status
- Active, not recruiting
- Sponsor
- Embody Orthopaedic Limited
- Enrollment
- 250
Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Observational
Eligibility Criteria
- Sex
- All
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
Investigators
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