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

NCT04326010 | Terminated FDA Device

• 1 other identifier: H.CR.I.AM.16.6
• Study Type: observational
• Target: 206
• Locations: 1 country
• Sites: 6

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.

Conditions

Hip Osteoarthritis

Outcome Measures

Primary Outcomes (1)

• Implant Survival

  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.

  5 years postoperatively / Life of Study

Secondary Outcomes (5)

• Clinical Outcomes

  7 Years Post-Operative.

• Functional Outcomes

  7 Years Post-Operative

• Radiographic Outcomes

  7 Years Post-Operative

• Quality of Life Outcomes

  7 Years Post-Operative

• Safety Outcomes

  10 Years Post-Operative

Interventions

Surgery DEVICE

THA surgery

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population will comprise a cohort of a minimum of 200, and no more than 225, hips enrolled across up to 10 centers from subjects who require primary total hip arthroplasty. Subjects must be willing and able to attend required follow-up appointments. Candidates who express interest in study participation will undergo an informed consent procedure, be required to sign an IRB-approved informed consent with required HIPAA authorization1, and eligibility will be determined based upon the inclusion/exclusion criteria.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Zimmer Biomet: lead

Study Sites (6)

OrthoSports Associates

Birmingham, Alabama, 35211, United States

Location

University of CA - San Diego

San Diego, California, 92037, United States

Location

Southern Joint Replacement Institute

Nashville, Tennessee, 37203, United States

Location

Growth Ortho

Austin, Texas, 78751, United States

Location

Tidewater Orthpaedics

Hampton, Virginia, 23666, United States

Location

Jordan-young Institute

Virginia Beach, Virginia, 23462, United States

Location

MeSH Terms

Conditions

Osteoarthritis, Hip

Interventions

Surgical Procedures, Operative

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Hillary Overholser, BS

  Zimmer Biomet

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 24, 2020
• First Posted: March 30, 2020
• Study Start: February 20, 2017
• Primary Completion: June 14, 2024
• Study Completion: December 4, 2024
• Last Updated: February 5, 2025

Record last verified: 2025-01

Locations

US (6)