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
This trial accepts healthy volunteersQualifiers
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 population
PIs will recruit from their patient population; patients already intending to undergo a total hip replacement.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
EcoFit® Total Hip System with implacross® E Polyethylene
DeviceThe EcoFit® Total Hip System is a primary hip replacement system indicated for patients who are candidates for a primary cementless hip replacement. implacross® E Polyethylene is one of the components in the EcoFit® system.
Treatment groups
500 Participants
are divided into 1 treatment groupGroup A: EcoFit® Total Hip System with implacross® E Polyethylene1 intervention
Trial outcomes
Primary outcomes
1
Survival of the EcoFit Hip with implacross E polyethylene for total hip replacement surgery
Evaluate the overall survivorship of the devices. Observed product-related complications and revisions are recorded and documented.
Time frame
36 monthsSecondary outcomes
1
Evaluate the pre to post-op change in the Harris Hip Score
The Harris Hip Score tracks pain, function/gait, performance in functional activities, and range of motion as interpreted by the surgeon. The responses determine a score which can be compared in different intervals.
Time frame
Pre-op, 6 months, 12 months, 24 months, 36 months2
Evaluate the pre to post-op change in the WOMAC Score
The Western Ontario McMaster Arthritis Index, a questionnaire completed by the patient, tracks pain, stiffness, and difficulty with daily activities.
Time frame
Pre-op, 6 months, 12 months, 24 months, 36 months3
Device related complications
Detect any device related complications via the adverse events reporting
Time frame
Through completion of study, an average of 3.5 yearsLocations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: