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

Last updated: March 16, 2026
Sponsor: Zimmer Biomet
Overall Status: Active - Enrolling

Phase

N/A

Condition

Osteoporosis

Treatment

Echo FX Stem with RingLoc Bipolar Acetabular Cup and Femoral Head

RingLoc Bipolar Acetabular Cup

Endo II Femoral Head

Clinical Study ID

NCT05199870
MDRG2017-89MS-43H
  • Ages > 18
  • All Genders

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 Criteria

Inclusion

Inclusion Criteria:

  • Patient must be 18 years of age or older and skeletally mature

  • Patient must have undergone hip hemiarthroplasty surgery with the RingLoc BipolarAcetabular Cup or Endo II Femoral Head for a cleared indication, greater than orequal to eight years previous to the date of study consent. Cleared indications forthe RingLoc Bipolar and Endo II Heads include the following:

  • Noninflammatory degenerative joint disease including osteoarthritis andavascular necrosis

  • Rheumatoid arthritis

  • Correction of functional deformity

  • Treatment of non-union, femoral neck fracture, and trochanteric fractures ofthe proximal femur with head involvement, unmanageable using other techniques.

Exclusion

Exclusion Criteria:

  • Any medical diagnosis present at the time of surgery that, at the Investigator'sdiscretion, could compromise the implant's survivability

  • Off-label use or not according to the approved instructions for use (IFU) of studydevices

  • Revision procedures where other treatment or devices have failed

  • Uncooperative patient or patient with neurologic disorders who is incapable offollowing directions

  • Patient has a psychiatric illness or

Study Design

Total Participants: 116
Treatment Group(s): 3
Primary Treatment: Echo FX Stem with RingLoc Bipolar Acetabular Cup and Femoral Head
Phase:
Study Start date:
March 10, 2026
Estimated Completion Date:
March 31, 2027

Study Description

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).

The primary objective of this study is the assessment of safety by analyzing implant survivorship at the longest follow-up timepoint available, greater than or equal to eight years post-implantation. This will be established by recording the incidence and frequency of revisions, complications, and adverse events. Relationship of the events to implant, instrumentation and/or procedure should be specified.

The secondary objective is the assessment of performance and clinical benefits by recording patient-reported clinical outcomes measures (PROMs).

Connect with a study center

  • Vicksburg Clinic, LLC

    Vicksburg, Mississippi 39183
    United States

    Site Not Available

  • Inova Fairfax Hospital

    Falls Church, Virginia 22042
    United States

    Site Not Available

  • Inova Fairfax Hospital

    Falls Church 4758390, Virginia 6254928 22042
    United States

    Site Not Available

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