MDR - PMCF Study for RingLoc Bipolar Acetabular Cup and Endo II Femoral Heads
Condition(s) studied
Investigational drug(s) / intervention(s)
RingLoc Bipolar Acetabular Cup: Patients that have been implanted with a RingLoc Bipolar acetabular cup.
Endo II Femoral Head: Subjects that have been implanted with an Endo II Femoral Head
Study summary
The objective of this retrospective enrollment/prospective follow-up consecutive series PMCF study is to collect data confirming safety, performance, and clinical benefits of the RingLoc Bipolar Acetabular Cup and the Endo II Femoral Head when used for hip hemiarthroplasty (implants and instrumentation).
Eligibility
Primary outcome measure(s)
- Device safety assessed through the frequency and incidence of revisions, complications, and Adverse Events. — Greater than or equal to 8 years.
The primary objective of this study is the assessment of safety by analyzing implant survivorship. This will be established by recording the incidence and frequency of revisions, complications, and Adverse Events. Relation of the events to either implant or instrumentation will be specified.
Trial sites (1)
| Facility | City | Region | Status |
|---|---|---|---|
| Inova Fairfax Hospital | Falls Church | Virginia |
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This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT05199870 on ClinicalTrials.gov ↗ ← All trials in the USA