Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
120 participants
OBSERVATIONAL
2025-08-31
2036-07-31
Brief Summary
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To ensure maximum safety and performance of medical devices, surveillance of the device should be carried out over the device's lifetime. This study is a 10-year surveillance study to assess the clinical, functional, and radiological outcomes of the CE-marked ACE Acetabular Cup System. This will be done by examining patient outcomes through questionnaires, reviews of X-rays, and recording any complications in patients who have received a total hip replacement using the ACE Acetabular Cup System at participating sites.
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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ACE Acetabular Cup System with XLPE Liner
Total Hip Replacement
Primary elective total hip replacement
ACE Acetabular Cup System with Ceramic Liner
Total Hip Replacement
Primary elective total hip replacement
Interventions
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Total Hip Replacement
Primary elective total hip replacement
Eligibility Criteria
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Inclusion Criteria
* Male or female, 18 years to 85 years.
Exclusion Criteria
* Patients deemed unsuitable for THR, as per contra-indications in the IFU.
* Patients indicated for THR as a result of trauma (i.e. neck of femur fracture).
* Patients receiving implants other than the approved combination, i.e. an ACE Acetabular Cup System with a JRI femoral stem and head.
* Patients who are unable to comply with the protocol.
18 Years
85 Years
ALL
No
Sponsors
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JRI Orthopaedics
INDUSTRY
Responsible Party
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Locations
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Hospital General de Granollers
Barcelona, Catalonia, Spain
Countries
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Other Identifiers
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JRI-CS-011
Identifier Type: -
Identifier Source: org_study_id
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