MDR - PMCF Study for RingLoc Bipolar Acetabular Cup

Last updated: December 20, 2024
Sponsor: Zimmer Biomet
Overall Status: Suspended

Phase

N/A

Condition

Osteoporosis

Treatment

Echo FX Stem with RingLoc Bipolar Acetabular Cup and 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 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 be willing and able to sign IRB approved informed consent

  • Non-inflammatory degenerative joint disease including osteoarthritis and avascularnecrosis

  • Rheumatoid arthritis

  • Correction of functional deformity

  • Treatment of non-union, femoral neck fracture and trochanteric fractures of theproximal femur with head involvement, unmanageable by other techniques

  • Revision procedures where other treatment or devices have failed

Exclusion

Exclusion Criteria:

  • Off-label use

  • Uncooperative patient or patient with neurological disorders who are incapable offollowing directions

  • Osteoporosis

  • Metabolic disorders which may impair bone formation

  • Osteomalacia

  • Distant foci of infections which may spread to the implant site

  • Rapid joint destruction, marked bone loss or bone resorption apparent onroentgenogram

  • Vascular insufficiency, muscular atrophy, or neuromuscular disease

  • Infection

  • Sepsis

  • Osteomyelitis

  • Patient is known to be pregnant or nursing

  • Patient is a prisoner

  • Patient is a known alcohol or drug abuser

  • Patient has a psychiatric illness or cognitive deficit that will not allow forproper informed consent

  • Patient is unwilling to sign an informed consent

Study Design

Total Participants: 58
Treatment Group(s): 1
Primary Treatment: Echo FX Stem with RingLoc Bipolar Acetabular Cup and Femoral Head
Phase:
Study Start date:
April 01, 2025
Estimated Completion Date:
September 03, 2030

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 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

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