Clinical trial NCT04918680: Prospective Post-market Study Examining the Effectiveness of the EcoFit®
Official title: Prospective Post-market Study Examining the Effectiveness of the EcoFit® Total Hip System With Implacross® E Polyethylene
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Degenerative Joint Disease
Femoral Fracture
Osteoarthritis, Hip
Traumatic Arthritis
Lead sponsor: Implantcast North America, LLC
Sponsor class: INDUSTRY
First posted: 2021-06-09
Enrollment: 500
Sex: ALL
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: PIs will recruit from their patient population; patients already intending to undergo a total hip replacement.

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.

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)

Primary outcomes:
measure: Survival of the EcoFit Hip with implacross E polyethylene for total hip replacement surgery
timeFrame: 36 months
Secondary outcomes:
measure: Evaluate the pre to post-op change in the Harris Hip Score
timeFrame: Pre-op, 6 months, 12 months, 24 months, 36 months
measure: Evaluate the pre to post-op change in the WOMAC Score
timeFrame: Pre-op, 6 months, 12 months, 24 months, 36 months
measure: Device related complications
timeFrame: Through completion of study, an average of 3.5 years
Other outcomes:
Locations:
Study officials:
References: