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出境医 / 临床实验 / Prospective Post-market Study Examining the Effectiveness of the EcoFit®

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

Study Description
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.

Condition or disease Intervention/treatment
Degenerative Joint Disease Femoral Fracture Osteoarthritis, Hip Traumatic Arthritis 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 Design
Layout table for study information
Study Type : Observational
Estimated Enrollment : 500 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prospective Post-market Study Examining the Effectiveness of the EcoFit® Total Hip System With Implacross® E Polyethylene
Estimated Study Start Date : June 21, 2021
Estimated Primary Completion Date : December 30, 2026
Estimated Study Completion Date : March 30, 2027
Arms 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.
Outcome Measures
Primary Outcome Measures :
  1. Survival of the EcoFit Hip with implacross E polyethylene for total hip replacement surgery [ Time Frame: 36 months ]
    Evaluate the overall survivorship of the devices. Observed product-related complications and revisions are recorded and documented.


Secondary Outcome Measures :
  1. Evaluate the pre to post-op change in the Harris Hip Score [ Time Frame: Pre-op, 6 months, 12 months, 24 months, 36 months ]
    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.

  2. Evaluate the pre to post-op change in the WOMAC Score [ Time Frame: Pre-op, 6 months, 12 months, 24 months, 36 months ]
    The Western Ontario McMaster Arthritis Index, a questionnaire completed by the patient, tracks pain, stiffness, and difficulty with daily activities.

  3. Device related complications [ Time Frame: Through completion of study, an average of 3.5 years ]
    Detect any device related complications via the adverse events reporting


Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   40 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
PIs will recruit from their patient population; patients already intending to undergo a total hip replacement.
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)
Contacts and Locations

No Contacts or Locations Provided

Tracking Information
First Submitted Date May 13, 2021
First Posted Date June 9, 2021
Last Update Posted Date June 9, 2021
Estimated Study Start Date June 21, 2021
Estimated Primary Completion Date December 30, 2026   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: June 1, 2021) 		Survival of the EcoFit Hip with implacross E polyethylene for total hip replacement surgery [ Time Frame: 36 months ]
Evaluate the overall survivorship of the devices. Observed product-related complications and revisions are recorded and documented.
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures
 (submitted: June 1, 2021)
  • Evaluate the pre to post-op change in the Harris Hip Score [ Time Frame: Pre-op, 6 months, 12 months, 24 months, 36 months ]
    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.
  • Evaluate the pre to post-op change in the WOMAC Score [ Time Frame: Pre-op, 6 months, 12 months, 24 months, 36 months ]
    The Western Ontario McMaster Arthritis Index, a questionnaire completed by the patient, tracks pain, stiffness, and difficulty with daily activities.
  • Device related complications [ Time Frame: Through completion of study, an average of 3.5 years ]
    Detect any device related complications via the adverse events reporting
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title 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
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.
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population PIs will recruit from their patient population; patients already intending to undergo a total hip replacement.
Condition
  • Degenerative Joint Disease
  • Femoral Fracture
  • 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.
Study Groups/Cohorts 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.
Intervention: Device: EcoFit® Total Hip System with implacross® E Polyethylene
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Not yet recruiting
Estimated Enrollment
 (submitted: June 1, 2021) 		500
Original Estimated Enrollment Same as current
Estimated Study Completion Date March 30, 2027
Estimated Primary Completion Date December 30, 2026   (Final data collection date for primary outcome measure)
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)
Sex/Gender
Sexes Eligible for Study: All
Ages 40 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts
Listed Location Countries Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number NCT04918680
Other Study ID Numbers EcoFit® Post-market Study
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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
IPD Sharing Statement
Plan to Share IPD: Undecided
Responsible Party Implantcast North America, LLC
Study Sponsor Implantcast North America, LLC
Collaborators Not Provided
Investigators Not Provided
PRS Account Implantcast North America, LLC
Verification Date June 2021