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.
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.
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