Prospective Post-market Study Examining the Effectiveness of the EcoFit®
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age40-75
SponsorImplantcast North America, LLC
About this trial
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
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)
Trial design
Treatments tested in this trial
- EcoFit® Total Hip System with implacross® E Polyethylene
Treatment groups
500 Participants
are divided into 1 treatment groupLocations
This trial has no locations
Sponsors and collaborators
Implantcast North America, LLC
Lead sponsor
Source ClinicalTrials.gov