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

Implantcast

Status: Not yet enrolling

Conditions: Osteoarthritis, Hip; Traumatic Arthritis; Femoral Fracture; Degenerative Joint Disease

Treatments: Device: EcoFit® Total Hip System with implacross® E Polyethylene

Study type: Observational

Funder types: Industry

Identifiers

NCT04918680

EcoFit® Post-market Study

Details and patient eligibility

About

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.

Full 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.

Enrollment: 500 estimated patients

Sex: All

Ages: 40 to 75 years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

500 participants in 1 patient group

EcoFit® Total Hip System with implacross® E Polyethylene

Description:

Subjects who meet the indications for use for the EcoFit® Total Hip System with implacross® E Polyethylene and are candidates for a primary hip replacement.

Treatment:

Device: EcoFit® Total Hip System with implacross® E Polyethylene