- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05199870
MDR - PMCF Study for Echo FX Stem With RingLoc Bipolar Acetabular Cup and Femoral Head
Post-market Clinical Follow-up Study to Provide Safety, Performance and Clinical Benefits Data of the Echo FX Stem With the RingLoc Bipolar Acetabular Cup and Femoral Head (Implants and Instrumentation) in Hip Hemiarthroplasty - A Retrospective Enrollment/Prospective Follow-up Consecutive Series Study
Study Overview
Status
Intervention / Treatment
Detailed Description
The objective of this retrospective enrollment and prospective follow-up study is to confirm safety, performance, and clinical benefits of the Echo FX Stem with the RingLoc Bipolar Acetabular Cup and Femoral Head in hip hemiarthroplasty (implants and instrumentation) at a minimum of 10 years follow-up. All available retrospective data will be collected from each patient and a prospective aspect to the study will be necessary to reach the 10-year time point.
The primary objective is to confirm the safety of the implants. This will be assessed by recording and analyzing the incidence and frequency of revisions, complications and adverse events. Relationship of the events to either implant or instrumentation will be specified.
The secondary objective is the assessment of performance and clinical benefits by analyzing recorded Patient Reported Outcomes Measures (PROMs).
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Richard Marek
- Phone Number: 574-453-7567
- Email: richard.marek@zimmerbiomet.com
Study Locations
-
-
Mississippi
-
Vicksburg, Mississippi, United States, 39183
- Recruiting
- Vicksburg Clinic, LLC
-
Contact:
- William Porter, M.D.
- Phone Number: 601-631-4701
- Email: wcpjr73@gmail.com
-
Principal Investigator:
- William Porter, M.D.
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Patient must be 18 years of age or older and skeletally mature
- Patient must be willing and able to sign IRB approved informed consent
- Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis
- Rheumatoid arthritis
- Correction of functional deformity
- Treatment of non-union, femoral neck fracture and trochanteric fractures of the proximal femur with head involvement, unmanageable by other techniques
- Revision procedures where other treatment or devices have failed
Exclusion Criteria:
- Off-label use
- Uncooperative patient or patient with neurological disorders who are incapable of following directions
- Osteoporosis
- Metabolic disorders which may impair bone formation
- Osteomalacia
- Distant foci of infections which may spread to the implant site
- Rapid joint destruction, marked bone loss or bone resorption apparent on roentgenogram
- Vascular insufficiency, muscular atrophy, or neuromuscular disease
- Infection
- Sepsis
- Osteomyelitis
- Patient is known to be pregnant or nursing
- Patient is a prisoner
- Patient is a known alcohol or drug abuser
- Patient has a psychiatric illness or cognitive deficit that will not allow for proper informed consent
- Patient is unwilling to sign an informed consent
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Echo FX Stem with RingLoc Bipolar Acetabular Cup and Femoral Head
Patients that have been implanted with a Echo FX stem with RingLoc Bipolar acetabular cup and femoral head to repair hip malfunction/disease/injury.
|
Patients that have been implanted with a Echo FX stem with RingLoc Bipolar acetabular cup and femoral head.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Device safety assessed through the frequency and incidence of revisions, complications, and Adverse Events.
Time Frame: Out to 10 years.
|
The primary objective of this study is the assessment of safety by analyzing implant survivorship.
This will be established by recording the incidence and frequency of revisions, complications, and Adverse Events.
Relation of the events to either implant or instrumentation will be specified.
|
Out to 10 years.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Device Performance and Benefits evaluated through the Oxford Hip Score.
Time Frame: Out to 10 years.
|
The OHS is a patient-completed, 12-question evaluation.
Each item is scored from 1 to 5, with 1 representing best outcome/least symptoms and 5 representing worst outcome/most symptoms.
|
Out to 10 years.
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Jarrod Hunnicutt, Zimmer Biomet
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- MDRG2017-89MS-43H
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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