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

NCT ID: NCT04326010

Last Updated: 2025-02-05

Basic Information

• Recruitment Status: TERMINATED
• Total Enrollment: 206 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2017-02-20
• Study Completion Date: 2024-12-04

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.

Conditions

Hip Osteoarthritis

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

Surgery

THA surgery

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Zimmer Biomet

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Hillary Overholser, BS

Role: STUDY_DIRECTOR

Zimmer Biomet

Locations

OrthoSports Associates

Birmingham, Alabama, United States

University of CA - San Diego

San Diego, California, United States

Southern Joint Replacement Institute

Nashville, Tennessee, United States

Growth Ortho

Austin, Texas, United States

Tidewater Orthpaedics

Hampton, Virginia, United States

Jordan-young Institute

Virginia Beach, Virginia, United States

Countries

United States

Other Identifiers

H.CR.I.AM.16.6

Identifier Type: -

Identifier Source: org_study_id