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

Hip Osteoarthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04326010
• Other study ID #: H.CR.I.AM.16.6
• Status: Active, not recruiting
• Start date: February 20, 2017
• Est. completion date: February 20, 2030

Study information

• Verified date: January 2024
• Source: Zimmer Biomet
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 206
• Est. completion date: February 20, 2030
• Est. primary completion date: February 20, 2029
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Hip Osteoarthritis
• Osteoarthritis, Hip

Intervention

Device:
• Surgery
THA surgery

Locations

Country	Name	City	State
United States	Growth Ortho	Austin	Texas
United States	OrthoSports Associates	Birmingham	Alabama
United States	Tidewater Orthpaedics	Hampton	Virginia
United States	Southern Joint Replacement Institute	Nashville	Tennessee
United States	University of CA - San Diego	San Diego	California
United States	Jordan-young Institute	Virginia Beach	Virginia

Sponsors (1)

Lead Sponsor	Collaborator
Zimmer Biomet

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Clinical Outcomes	Clinical Outcomes will be measured using the Harris Hip Score and Physical Exam form.	7 Years Post-Operative.
Secondary	Functional Outcomes	Functional ability will be measured using the EQ-5D-3L.	7 Years Post-Operative
Secondary	Radiographic Outcomes	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	7 Years Post-Operative
Secondary	Quality of Life Outcomes	Will be measured by UCLA Activity Score	7 Years Post-Operative
Secondary	Safety Outcomes	Will be evaluated by monitoring the frequency and incidence of adverse events over time of the study	10 Years Post-Operative