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

Launched by IMPLANTCAST NORTH AMERICA, LLC · Jun 1, 2021

Keywords

ClinConnect Summary

This clinical trial is studying the effectiveness and safety of a device called the EcoFit Hip, which is used during total hip replacement surgery. The goal is to see how well this device works for people with conditions like degenerative joint disease, osteoarthritis, traumatic arthritis, or those who have a femoral fracture that needs treatment through hip replacement.

To participate in the study, individuals must be candidates for total hip replacement and have a body mass index (BMI) of 40 or less. They should also be available for follow-up evaluations throughout the study and be willing to sign consent forms. However, people who have had a previous hip replacement in the same hip, certain health conditions, or who are pregnant cannot join the study. Participants can expect to receive the EcoFit Hip during their surgery and will be monitored to ensure their safety and to evaluate the device's effectiveness over time. This study is not yet recruiting participants, so there is still time for potential candidates to consider their eligibility.

Gender

ALL

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)