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

Prospective Post-market Study Examining the Effectiveness of the EcoFit® Total Hip System With Implacross® E Polyethylene

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Femoral Fracture; Osteoarthritis, Hip; Traumatic Arthritis; Degenerative Joint Disease
• Intervention / Treatment: Device: EcoFit® Total Hip System with implacross® E Polyethylene

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.

• Study Type: Observational
• Enrollment (Anticipated): 500

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

PIs will recruit from their patient population; patients already intending to undergo a total hip replacement.

Description

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)

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
EcoFit® Total Hip System with implacross® E Polyethylene; Subjects who meet the indications for use for the EcoFit® Total Hip System with implacross® E Polyethylene and are candidates for a primary hip replacement.	Device: EcoFit® Total Hip System with implacross® E Polyethylene; The 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	36 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Pre-op, 6 months, 12 months, 24 months, 36 months
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.	Pre-op, 6 months, 12 months, 24 months, 36 months
Device related complications	Detect any device related complications via the adverse events reporting	Through completion of study, an average of 3.5 years

Collaborators and Investigators

• Sponsor: Implantcast North America, LLC

Study record dates

Study Major Dates

• Study Start (Anticipated): June 21, 2021
• Primary Completion (Anticipated): December 30, 2026
• Study Completion (Anticipated): March 30, 2027

Study Registration Dates

• First Submitted: May 13, 2021
• First Submitted That Met QC Criteria: June 1, 2021
• First Posted (Actual): June 9, 2021

Study Record Updates

• Last Update Posted (Actual): June 9, 2021
• Last Update Submitted That Met QC Criteria: June 1, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Fractures, Bone; Wounds and Injuries; Leg Injuries; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Femoral Fractures; Osteoarthritis; Joint Diseases; Osteoarthritis, Hip
• Other Study ID Numbers: EcoFit® Post-market Study

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No