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

Part of paid clinical trials in Falls Church, Virginia.

Sponsor
Zimmer Biomet
Study ID
NCT05199870
Status
Enrolling By Invitation

Conditions

  • Hip Arthritis
  • Hip Disease
  • Hip Fractures
  • Hip Injuries
  • Hip Pain Chronic

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • RingLoc Bipolar Acetabular Cup — DEVICE
    Patients that have been implanted with a RingLoc Bipolar acetabular cup.
  • Endo II Femoral Head — DEVICE
    Subjects that have been implanted with an Endo II Femoral Head

Study Details

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).

Key Dates

Start date
Mar 10, 2026
Status verified
Mar 2026
Primary completion
Mar 31, 2027
Completion
Mar 31, 2027

Study Design

Enrollment
116 participants (estimated)

Arms

  • Arm: RingLoc Bipolar Acetabular Cup
    Patients that have been implanted with the RingLoc Bipolar acetabular cup to repair hip malfunction/disease/injury.
  • Arm: Endo II Femoral Heads
    Subjects who were implanted with the Endo II Femoral head during hemiarthroplasty

Primary Outcome Measure

Device safety assessed through the frequency and incidence of revisions, complications, and Adverse Events. [ Time Frame: Greater than or equal to 8 years. ]

Locations (1)

FacilityCityStateZIPSite coordinators
Inova Fairfax HospitalFalls ChurchVirginia22042-

Find similar trials in Falls Church, VA

By research site
Inova Fairfax Hospital· Falls Church, VA

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