MDR - PMCF Study for Echo FX Stem With RingLoc Bipolar Acetabular Cup and Femoral Head

Description

The objective of this retrospective enrollment and prospective follow-up study is to confirm safety, performance, and clinical benefits of the Echo FX Stem with the RingLoc Bipolar Acetabular Cup and Femoral Head in hip hemiarthroplasty (implants and instrumentation) at a minimum of 10 years follow-up. All available retrospective data will be collected from each patient and a prospective aspect to the study will be necessary to reach the 10-year time point.

Conditions

Hip Arthritis, Hip Disease, Hip Fractures, Hip Injuries, Hip Pain Chronic

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Study Overview

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Study Details

Study overview

The objective of this retrospective enrollment and prospective follow-up study is to confirm safety, performance, and clinical benefits of the Echo FX Stem with the RingLoc Bipolar Acetabular Cup and Femoral Head in hip hemiarthroplasty (implants and instrumentation) at a minimum of 10 years follow-up. All available retrospective data will be collected from each patient and a prospective aspect to the study will be necessary to reach the 10-year time point.

Post-market Clinical Follow-up Study to Provide Safety, Performance and Clinical Benefits Data of the Echo FX Stem With the RingLoc Bipolar Acetabular Cup and Femoral Head (Implants and Instrumentation) in Hip Hemiarthroplasty - A Retrospective Enrollment/Prospective Follow-up Consecutive Series Study

MDR - PMCF Study for Echo FX Stem With RingLoc Bipolar Acetabular Cup and Femoral Head

Condition
Hip Arthritis
Intervention / Treatment

-

Contacts and Locations

Vicksburg

Vicksburg Clinic, LLC, Vicksburg, Mississippi, United States, 39183

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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 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 by other techniques
  • * Revision procedures where other treatment or devices have failed
  • * Off-label use
  • * Uncooperative patient or patient with neurological disorders who are incapable of following 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 on roentgenogram
  • * 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 for proper informed consent
  • * Patient is unwilling to sign an informed consent

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Zimmer Biomet,

Jarrod Hunnicutt, STUDY_DIRECTOR, Zimmer Biomet

Study Record Dates

2030-09-03