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

Osteoarthritis, Hip Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04918680
• Other study ID #: EcoFit® Post-market Study
• Status: Not yet recruiting
• Start date: June 21, 2021
• Est. completion date: March 30, 2027

Study information

• Verified date: June 2021
• Source: Implantcast North America, LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 500
• Est. completion date: March 30, 2027
• Est. primary completion date: December 30, 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 40 Years to 75 Years

Eligibility

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)

Related Conditions & MeSH terms

• Degenerative Joint Disease
• Femoral Fracture
• Femoral Fractures
• Joint Diseases
• Osteoarthritis
• Osteoarthritis, Hip
• Traumatic Arthritis

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Implantcast North America, LLC

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	Device related complications	Detect any device related complications via the adverse events reporting	Through completion of study, an average of 3.5 years