Status:
NOT_YET_RECRUITING
Prospective Post-market Study Examining the Effectiveness of the EcoFit®
Lead Sponsor:
Implantcast North America, LLC
Conditions:
Degenerative Joint Disease
Femoral Fracture
Eligibility:
All Genders
40-75 years
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 ...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
June 21 2021
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
March 30 2027
Estimated Enrollment :
500 Patients enrolled
Trial Details
Trial ID
NCT04918680
Start Date
June 21 2021
End Date
March 30 2027
Last Update
June 9 2021
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