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

NCT04918680 | Not Yet Recruiting FDA Device

• 1 other identifier: EcoFit® Post-market Study
• Study Type: observational
• Target: 500
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Degenerative Joint Disease; Femoral Fracture; Osteoarthritis, Hip; Traumatic Arthritis

Outcome Measures

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.

  36 months

Secondary Outcomes (3)

• Evaluate the pre to post-op change in the Harris Hip Score

  Pre-op, 6 months, 12 months, 24 months, 36 months

• Evaluate the pre to post-op change in the WOMAC Score

  Pre-op, 6 months, 12 months, 24 months, 36 months

• Device related complications

  Through completion of study, an average of 3.5 years

Study Arms (1)

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

Interventions

EcoFit® Total Hip System with implacross® E Polyethylene DEVICE

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.

EcoFit® Total Hip System with implacross® E Polyethylene

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Implantcast North America, LLC: lead

MeSH Terms

Conditions

Joint Diseases; Femoral Fractures; Osteoarthritis, Hip

Condition Hierarchy (Ancestors)

Musculoskeletal Diseases; Fractures, Bone; Wounds and Injuries; Leg Injuries; Osteoarthritis; Arthritis; Rheumatic Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 13, 2021
• First Posted: June 9, 2021
• Study Start: June 21, 2021
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): March 30, 2027
• Last Updated: June 9, 2021

Record last verified: 2021-06