RECRUITING

Exactech Proximal Humerus Fracture Plate System Post Market Clinical Follow-up

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Conditions

Proximal Humeral FractureFracture DislocationNon-Union Fracture

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The objective of this study is to collect and evaluate long-term clinical outcomes data in order to better understand the safety and performance of the Equinoxe Proximal Humerus Fracture Plates over time. This study will follow subjects for a period of up to 10 years post-surgery.

Official Title

An Open Label, Multi-Center, Retrospective and Prospective Evaluation of Equinoxe Proximal Humerus Fracture Plates Clinical and Radiographic Outcomes

Quick Facts

Study Start:2023-04-19
Study Completion:2034-09-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05703958

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:21 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Patient is indicated to receive Equinoxe Proximal Humerus Fracture Plate or has previously underwent primary surgery with Equioxe Proximal Humerus Fracture Plate
  2. * Patient is willing to participate by complying with pre- and postoperative visit requirements
  3. * Patient is willing to agree to be followed for up to 10 years following their index surgery
  4. * Patient is willing and able to review and sign a study informed consent form
  1. * Osteomyelitis of the proximal humerus or scapula
  2. * Inadequate or malformed bone that precludes adequate support or fixation of the prosthesis
  3. * Patient's age, weight, or activity level would cause the surgeon to expect early failure of the system
  4. * The patient is unwilling or unable to comply with the post-operative care instructions
  5. * Alcohol, drug, or other subtance abuse
  6. * Any disease state that could adversaly affect the function or longevity of the implant
  7. * Patient is pregnant
  8. * Patient is a prisoner
  9. * Patient has a physical or mental condition that would invalidate the results

Contacts and Locations

Study Contact

Rachael Craig
CONTACT
352-377-1140
rachael.craig@exac.com
Sandrine Angibaud
CONTACT
352-377-1140
sandrine.angbaud@exac.com

Principal Investigator

Abhishek Ganta, MD
PRINCIPAL_INVESTIGATOR
NYU Grossman School of Medicine

Study Locations (Sites)

NYU Grossman School of Medicine
New York, New York, 10016
United States

Collaborators and Investigators

Sponsor: Exactech

  • Abhishek Ganta, MD, PRINCIPAL_INVESTIGATOR, NYU Grossman School of Medicine

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-04-19
Study Completion Date2034-09-30

Study Record Updates

Study Start Date2023-04-19
Study Completion Date2034-09-30

Terms related to this study

Additional Relevant MeSH Terms

  • Proximal Humeral Fracture
  • Fracture Dislocation
  • Non-Union Fracture