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

Stopped early

Conditions studied: Hip Osteoarthritis

In brief

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.

Key facts

Study ID

NCT04326010

Run by

Zimmer Biomet

People needed

206

Starts

2017-02-20

Expected to finish

2024-12-04

Last updated by the study team

2025-02-05

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

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

Where it is running

• 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

Full record on ClinicalTrials.gov

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