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

Implantcast North America, LLC0 sites500 target enrollmentJune 21, 2021

ConditionsDegenerative Joint Disease Femoral Fracture Osteoarthritis, Hip Traumatic Arthritis

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Degenerative Joint Disease
Sponsor: Implantcast North America, LLC
Enrollment: 500
Primary Endpoint: Survival of the EcoFit Hip with implacross E polyethylene for total hip replacement surgery
Status: Not yet recruiting
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

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.

Registry

clinicaltrials.gov

Start Date

June 21, 2021

End Date

March 30, 2027

Last Updated

4 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Implantcast North America, LLC

Responsible Party

Sponsor

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

Outcomes

Primary Outcomes

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

Evaluate the pre to post-op change in the Harris Hip Score(Pre-op, 6 months, 12 months, 24 months, 36 months)
Evaluate the pre to post-op change in the WOMAC Score(Pre-op, 6 months, 12 months, 24 months, 36 months)
Device related complications(Through completion of study, an average of 3.5 years)