Metasul Monoblock Component™ Cup in a Hip Resurfacing Application With the Durom® Hip Resurfacing… (NCT03681639) | Clinical Trial Compass
CompletedNot Applicable
Metasul Monoblock Component™ Cup in a Hip Resurfacing Application With the Durom® Hip Resurfacing Femoral Component
Germany45 participantsStarted 2009-08-01
Plain-language summary
The Zimmer Hip Resurfacing System Post-Market Clinical Follow-up study will examine the safety and efficacy of this device in the young and/or active patient with advanced hip disease.
Who can participate
Age range18 Years – 65 Years
SexALL
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Inclusion criteria
âś“. Patient selection without bias to race or gender.
✓. Patient is ≥ 18 and ≤ 65 years of age.
âś“. Female patients only, if
âś“. Actively practicing a contraceptive method, or
âś“. Surgically sterilized, or
âś“. Post-menopausal
✓. Pre-operative Harris Hip Score ≤ 70.
âś“. Primary surgical hip candidate, suffering from hip pain and/or disability due to degenerative joint disease (inflammatory or non-inflammatory), based on physical examination and history, which may include the following diagnosis:
Exclusion criteria
âś•. Patient has an acute, chronic, local or systemic infection.
âś•. Patient is skeletally immature.
âś•. Patient is known to be pregnant.
âś•. Patient has a severe muscular, neural or vascular disease that endangers the involved extremity.
âś•. Patient has an insufficient acetabular or femoral bone stock in which good anchorage of the implants are unlikely or impossible, including, but not limited to: