Clinical trial NCT04326010: Prospective Clinical Follow-up of the Echo Bi-Metric Microplasty Stem for Total Hip Arthroplasty
Official title: Prospective Clinical Follow-up of the Echo Bi-Metric Microplasty Stem for Total Hip Arthroplasty
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Hip Osteoarthritis
Lead sponsor: Zimmer Biomet
Sponsor class: INDUSTRY
First posted: 2020-03-30
Enrollment: 206
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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

Primary outcomes:
measure: Implant Survival
timeFrame: 5 years postoperatively / Life of Study
Secondary outcomes:
measure: Clinical Outcomes
timeFrame: 7 Years Post-Operative.
measure: Functional Outcomes
timeFrame: 7 Years Post-Operative
measure: Radiographic Outcomes
timeFrame: 7 Years Post-Operative
measure: Quality of Life Outcomes
timeFrame: 7 Years Post-Operative
measure: Safety Outcomes
timeFrame: 10 Years Post-Operative
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: OrthoSports Associates
state: Alabama
city: San Diego
country: United States
facility: University of CA - San Diego
state: California
city: Nashville
country: United States
facility: Southern Joint Replacement Institute
state: Tennessee
city: Austin
country: United States
facility: Growth Ortho
state: Texas
city: Hampton
country: United States
facility: Tidewater Orthpaedics
state: Virginia
city: Virginia Beach
country: United States
facility: Jordan-young Institute
state: Virginia
Study officials:
affiliation: Zimmer Biomet
name: Hillary Overholser, BS
role: STUDY_DIRECTOR
References: