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Not yet recruiting NCT04918680

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

— Observational Degenerative Joint Disease Femoral Fracture Osteoarthritis, Hip Traumatic Arthritis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: EcoFit® Total Hip System with implacross® E Polyethylene.
Who it may be relevant to
Registry conditions: Degenerative Joint Disease, Femoral Fracture, Osteoarthritis, Hip, Traumatic Arthritis. Basic parameters: 40 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Detailed description

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.

Interventions

  • Device EcoFit® Total Hip System with implacross® E Polyethylene
    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 outcome measures

  • Survival of the EcoFit Hip with implacross E polyethylene for total hip replacement surgery [Time frame: 36 months]
Secondary outcome measures (3)
  • Evaluate the pre to post-op change in the Harris Hip Score [Time frame: Pre-op, 6 months, 12 months, 24 months, 36 months]
  • Evaluate the pre to post-op change in the WOMAC Score [Time frame: Pre-op, 6 months, 12 months, 24 months, 36 months]
  • Device related complications [Time frame: Through completion of study, an average of 3.5 years]

Eligibility criteria

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)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Cohort

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT04918680 · EcoFit® Post-market Study

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗