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NCT Number: NCT04918680

Prospective Post-market Study Examining the Effectiveness of the EcoFit®

The purpose of this study is to evaluate the safety and effectiveness of the EcoFit Hip with implacross E polyethylene for total hip replacement surgery.

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Key information

About this study

This study will assess the performance and success rate of the EcoFit Total Hip System. Survivorship and clinical outcomes will help determine implant success 36 months as defined by specific scoring systems and compared to other published data.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Subject must be a candidate for a total primary hip replacement.
  • Subject must have degenerative joint disease, including osteoarthritis or traumatic arthritis, OR a femoral fracture which can be treated by a primary hip replacement and no other hardware
  • Subject has a BMI of 40.00 kg/m2 or less at the time of enrollment
  • Subject is likely to be available for evaluation for the duration of the study
  • Subject is able and willing to sign the informed consent and follow study procedures
  • Subject is not pregnant

Exclusion criteria

  • Subject has had a prior hip replacement in the subject hip
  • Subject has an active cancer or is a survivor for <5 years except for squamous cell or basal cell skin cancer
  • Subject has a chronic disease(s) where, in the opinion of the investigator, the disease will interfere with the patient's ability to follow the protocol
  • Subject is currently a documented substance abuser (alcohol or other addictions)
  • Subject has an infection, or history of infection (within the last 3 months), acute or chronic, local or systemic
  • Subject has a history of muscular, neurological or vascular deficiencies which compromise the affected extremity
  • Subject has a BMI > 40.00 kg/m2
  • Subject has a mental condition that may interfere with the subject's ability to give an informed consent or willingness to fulfill the study requirements (i.e., severe mental retardation such that the Subject cannot understand the informed consent process, global dementia, prior strokes that interfere with the Subject's cognitive abilities, senile dementia, and Alzheimer's Disease)
  • Subject is a prisoner
  • Subject is pregnant
  • Subject has known materials sensitivity (to metals)

Treatment and study plan

EcoFit® Total Hip System with implacross® E Polyethylene

Device

The EcoFit® Total Hip System is a primary hip replacement system indicated for patients who are candidates for a primary cementless hip replacement. implacross® E Polyethylene is one of the components in the EcoFit® system.

Primary outcomes

  1. Survival of the EcoFit Hip with implacross E polyethylene for total hip replacement surgery

    Time frame: 36 months

    Evaluate the overall survivorship of the devices. Observed product-related complications and revisions are recorded and documented.

Secondary outcomes

  1. Evaluate the pre to post-op change in the Harris Hip Score

    Time frame: Pre-op, 6 months, 12 months, 24 months, 36 months

    The Harris Hip Score tracks pain, function/gait, performance in functional activities, and range of motion as interpreted by the surgeon. The responses determine a score which can be compared in different intervals.

  2. Evaluate the pre to post-op change in the WOMAC Score

    Time frame: Pre-op, 6 months, 12 months, 24 months, 36 months

    The Western Ontario McMaster Arthritis Index, a questionnaire completed by the patient, tracks pain, stiffness, and difficulty with daily activities.

  3. Device related complications

    Time frame: Through completion of study, an average of 3.5 years

    Detect any device related complications via the adverse events reporting

Sponsors and collaborators

Lead sponsor

Implantcast North America, LLC

Industry

Registry information

Official study title

Prospective Post-market Study Examining the Effectiveness of the EcoFit® Total Hip System With Implacross® E Polyethylene

Important dates

Study start
2021
Primary completion
2026
Study completion
2027
First posted
Jun 9, 2021
Registry last updated
Jun 9, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.