Clinical Trial Finder

MDR - PMCF Study for Echo FX Stem With RingLoc Bipolar Acetabular Cup and Femoral Head

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

 No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

 Observational
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

 NCT05199870
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

 Zimmer Biomet
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

 Jarrod Hunnicutt
Principal Investigator Affiliation Zimmer Biomet
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

 Industry
Overall Status Recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

 Hip Arthritis, Hip Disease, Hip Fractures, Hip Injuries, Hip Pain Chronic
Additional Details

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).

Arms & Interventions

Arms

: 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.

Interventions

Device: - 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.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Vicksburg Clinic, LLC, Vicksburg, Mississippi

Status

Recruiting

Address

Vicksburg Clinic, LLC

Vicksburg, Mississippi, 39183

Site Contact

William Porter, M.D.

[email protected]

601-631-4701

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