Prospective Clinical Follow-up of the Echo Bi-Metric Microplasty Stem for Total Hip Arthroplasty

Terminated

• Conditions: Hip Osteoarthritis

• Registration Number: NCT04326010
• Lead Sponsor: Zimmer Biomet

Brief Summary

The primary objective of this study is to characterize survivorship of the Echo Bi-Metric Microplasty stem in unilateral or bilateral primary total hip arthroplasty at 5 years postoperative.

Detailed Description

Primary objective

The primary objective of this study is to characterize survivorship of the Echo Bi-Metric Microplasty stem in unilateral or bilateral primary total hip arthroplasty at 5 years postoperative.

Secondary Objectives

Safety will be evaluated by monitoring the frequency and incidence of adverse events over time to 10 years postoperative.

Clinical, functional, radiographic, and quality of life outcomes will be assessed over time to 7 years postoperative. Clinical Outcomes will be measured using the Harris Hip Score and Physical Exam form. Radiographs will be reviewed to assess alignment, radiolucencies and other radiographic parameters. Health status and functional ability will be measured using the EQ-5D-3L and the UCLA Activity score.

Study Timeline

• Study Start: 2017-02-20
• Study First Submitted: 2020-01-24
• Study First Submitted QC: 2020-03-27
• Study First Posted: 2020-03-30
• Primary Completion: 2024-06-14
• Study Completion: 2024-12-04
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-31
• Last Update Posted: 2025-02-05

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 206

Inclusion Criteria

• Subjects are eligible for this trial if they satisfy all of the following criteria:

  • Patient is 18 to 65 years of age, inclusive
  • Patient is skeletally mature
  • Patient qualifies for primary unilateral or bilateral total hip arthroplasty based on physical exam and medical history including at least one of the following:
  • Osteoarthritis
  • 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
  • Patient has no history of previous total hip arthroplasty or arthrodesis of the affected hip joint(s)
  • Patient is willing and able to complete scheduled follow-up evaluations as described in the Informed Consent
  • Patient, or the patient's legally authorized representative, has participated in the Informed Consent process and is willing and able to sign an IRB- approved informed consent

Exclusion Criteria

• Subjects will be excluded from this trial if they satisfy any of the following criteria as determined by the research staff or in the judgment of the treating physician:

  • Patient has a total prosthetic hip replacement device (including surface replacement arthroplasty, endoprosthesis, etc.) in the affected hip joint(s)
  • Patient is septic or has an active infection
  • Patient is uncooperative patient or is incapable of following directions
  • Patient is diagnosed with osteoporosis
  • Patient is diagnosed with a metabolic disorder which may impair bone formation
  • Patient is diagnosed with osteomalacia
  • Patient has distant foci of infections which may spread to the implant site

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Implant Survival	5 years postoperatively / Life of Study	The primary objective of this study is to characterize survivorship of the Echo Bi-Metric Microplasty stem in unilateral or bilateral primary total hip arthroplasty at 5 years postoperative.

Secondary Outcome Measures

Name	Time	Method
Safety Outcomes	10 Years Post-Operative	Will be evaluated by monitoring the frequency and incidence of adverse events over time of the study
Radiographic Outcomes	7 Years Post-Operative	Standard AP and lateral Hip radiographics of the implanted hip device will be assess the positioning of the device as well as lucencies and other potential anomalies
Clinical Outcomes	7 Years Post-Operative.	Clinical Outcomes will be measured using the Harris Hip Score and Physical Exam form.
Functional Outcomes	7 Years Post-Operative	Functional ability will be measured using the EQ-5D-3L.
Quality of Life Outcomes	7 Years Post-Operative	Will be measured by UCLA Activity Score

Trial Locations

Locations (6)

OrthoSports Associates; 🇺🇸 Birmingham, Alabama, United States

Tidewater Orthpaedics; 🇺🇸 Hampton, Virginia, United States

Jordan-young Institute; 🇺🇸 Virginia Beach, Virginia, United States

University of CA - San Diego; 🇺🇸 San Diego, California, United States

Growth Ortho; 🇺🇸 Austin, Texas, United States

Southern Joint Replacement Institute; 🇺🇸 Nashville, Tennessee, United States