Ireland
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Enrolling by invitation Observational

MDR - PMCF Study for RingLoc Bipolar Acetabular Cup and Endo II Femoral Heads

NCT05199870 · tracked via the Priya Life Science USA tracker
Phase
Observational
Started
2026-03-10
Last updated
2026-03-19

Condition(s) studied

Hip ArthritisHip DiseaseHip FracturesHip InjuriesHip Pain Chronic

Investigational drug(s) / intervention(s)

RingLoc Bipolar Acetabular CupEndo II Femoral Head

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

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Patient must be 18 years of age or older and skeletally mature * Patient must have undergone hip hemiarthroplasty surgery with the RingLoc Bipolar Acetabular Cup or Endo II Femoral Head for a cleared indication, greater than or equal to eight years previous to the date of study consent. Cleared indications for the RingLoc Bipolar and Endo II Heads include the following: * Noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis * Rheumatoid arthritis * Correction of functional deformity * Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques. Exclusion Criteria: * Any medical diagnosis present at the time of surgery that, at the Investigator's discretion, could compromise the implant's survivability * Off-label use or not according to the approved instructions for use (IFU) of study devices * Revision procedures where other treatment or devices have failed * Uncooperative patient or patient with neurologic disorders who is incapable of following directions * Patient has a psychiatric illness or

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)

FacilityCityRegionStatus
Inova Fairfax Hospital Falls Church Virginia
Official registry record

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