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NCT05199870 | RECRUITING | Hip Arthritis

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

Zimmer Biomet

Brief Summary:

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.

Condition or disease

Hip Arthritis

Hip Disease

Hip Fractures

Hip Injuries

Hip Pain Chronic

Intervention/treatment

Echo FX Stem with RingLoc Bipolar Acetabular Cup and Femoral Head

Detailed 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. The primary objective is to confirm the safety of the implants. This will be assessed by recording and analyzing the incidence and frequency of revisions, complications and adverse events. Relationship of the events to either implant or instrumentation will be specified. The secondary objective is the assessment of performance and clinical benefits by analyzing recorded Patient Reported Outcomes Measures (PROMs).

Study Type : OBSERVATIONAL
Estimated Enrollment : 86 participants
Official Title : 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
Actual Study Start Date : 2021-12-17
Estimated Primary Completion Date : 2030-09-03
Estimated Study Completion Date : 2030-09-03

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
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 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
Exclusion Criteria
  • * 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
MDR - PMCF Study for Echo FX Stem With RingLoc Bipolar Acetabular Cup and Femoral Head

Location Details

NCT05199870

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How to Participate

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Locations

RECRUITING

United States, Mississippi

Vicksburg Clinic, LLC

Vicksburg, Mississippi, United States, 39183