Status:
TERMINATED
Prospective Clinical Follow-up of the Echo Bi-Metric Microplasty Stem for Total Hip Arthroplasty
Lead Sponsor:
Zimmer Biomet
Conditions:
Hip Osteoarthritis
Eligibility:
All Genders
18-65 years
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 posto...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 20 2017
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 4 2024
Estimated Enrollment :
206 Patients enrolled
Trial Details
Trial ID
NCT04326010
Start Date
February 20 2017
End Date
December 4 2024
Last Update
February 5 2025
Active Locations (6)
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1
OrthoSports Associates
Birmingham, Alabama, United States, 35211
2
University of CA - San Diego
San Diego, California, United States, 92037
3
Southern Joint Replacement Institute
Nashville, Tennessee, United States, 37203
4
Growth Ortho
Austin, Texas, United States, 78751