Degenerative Joint DiseaseNCT04918680
Prospective Post-market Study Examining the Effectiveness of the EcoFit®
An observational study of Degenerative Joint Disease and Femoral Fracture, run by Implantcast North America, LLC.
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. Read more about this study
- Who is it for?
- Ages 40 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Degenerative Joint Disease, Femoral Fracture, Osteoarthritis, Hip
- What is being tested?
- EcoFit® Total Hip System with implacross® E Polyethylene
- Type of treatment
- Medical device
- How many people
- 500 participants
- Where
- No sites listed yet
- Study dates
- 21 Jun 2021to 30 Mar 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: PIs will recruit from their patient population; patients already intending to undergo a total hip replacement.
Who may be able to join
- 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
Who cannot join
- 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
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- 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)
About this study
Official title: 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.
Read the 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.
- Being tested
- EcoFit® Total Hip System with implacross® E Polyethylene
- Medical subject headings
- Joint Diseases, Femoral Fractures, Osteoarthritis, Hip
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EcoFit® Total Hip System with implacross® E PolyethyleneDevice
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 group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: EcoFit® Total Hip System with implacross® E Polyethylene |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 36 months
Secondary outcomes (3)
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.
Measured: 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.
Measured: Pre-op, 6 months, 12 months, 24 months, 36 months
Device related complications
Detect any device related complications via the adverse events reporting
Measured: Through completion of study, an average of 3.5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2021
- Study start21 Jun 2021 (estimated)
- Primary completion30 Dec 2026 (estimated)
- Study completion30 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Degenerative Joint DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Implantcast North America, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04918680
- Sponsor's protocol ID
- EcoFit® Post-market Study
- Status last verified
- Jun 2021
- First submitted
- 13 May 2021
- Last updated
- 9 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Post-market Study Examining the Effectiveness of the EcoFit® Total Hip System With Implacross® E Polyethylene
- ClinicalTrials.gov ID
- NCT04918680
- Acronym / sponsor ID
- EcoFit® Post-market Study
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Implantcast North America, LLCIndustry (pharma, biotech, devices)
- Study start
- 21 Jun 2021 (estimated)
- Primary completion
- 30 Dec 2026 (estimated)
- Study completion
- 30 Mar 2027 (estimated)
- First posted
- 9 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| EcoFit® Total Hip System with implacross® E Polyethylene | – | Device: EcoFit® Total Hip System with implacross® E PolyethyleneSubjects who meet the indications for use for the EcoFit® Total Hip System with implacross® E Polyethylene and are candidates for a primary hip replacement. |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- PIs will recruit from their patient population; patients already intending to undergo a total hip replacement.
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EcoFit® Total Hip System with implacross® E PolyethyleneThe 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. | Device | EcoFit® Total Hip System with implacross® E Polyethylene |
Primary outcome
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.
3 secondary outcomes
Evaluate the pre to post-op change in the Harris Hip Score
Time frame: Pre-op, 6 months, 12 months, 24 months, 36 months
Evaluate the pre to post-op change in the WOMAC Score
Time frame: Pre-op, 6 months, 12 months, 24 months, 36 months
Device related complications
Time frame: Through completion of study, an average of 3.5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2021.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Degenerative Joint Disease and Femoral Fracture, run by Implantcast North America, LLC.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 9 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Survival of the EcoFit Hip with implacross E polyethylene for total hip replacement surgery (time frame: 36 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jun 2021.