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NCT05199870

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

Enrolling by Invitation
Not specifiedAges 18+Observational
Zimmer Biomet
~116 participants
Updated 2026-03-19 on ClinicalTrials.gov
What's tested:RingLoc Bipolar Acetabular CupEndo II Femoral Head

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Device safety assessed through the frequency and incidence of revisions, complications, and Adverse Events.
Measured over Greater than or equal to 8 years.

Conditions

Hip Arthritis
Hip Disease
Hip Fractures
Hip Injuries
Hip Pain Chronic

Explore related trials

Avascular NecrosisFracture of neck of femurFunctional DeformityNon-unionOsteoarthritisRheumatoid ArthritisTrochanteric Fractures

Where it's being run

1 sites across 1 states
Virginia1

Study leadership

  • Lynsey Boyle · STUDY_DIRECTOR · Zimmer Biomet

Who to contact

This trial hasn't published a contact. View it on ClinicalTrials.gov

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • 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.