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

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.

Conditions

Proximal Humeral Fracture, Fracture Dislocation, Non-Union Fracture

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Study Overview

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Study Details

Study overview

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.

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

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

Condition
Proximal Humeral Fracture
Intervention / Treatment

-

Contacts and Locations

New York

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

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.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * Patient is indicated to receive Equinoxe Proximal Humerus Fracture Plate or has previously underwent primary surgery with Equioxe Proximal Humerus Fracture Plate
  • * Patient is willing to participate by complying with pre- and postoperative visit requirements
  • * Patient is willing to agree to be followed for up to 10 years following their index surgery
  • * Patient is willing and able to review and sign a study informed consent form
  • * Osteomyelitis of the proximal humerus or scapula
  • * Inadequate or malformed bone that precludes adequate support or fixation of the prosthesis
  • * Patient's age, weight, or activity level would cause the surgeon to expect early failure of the system
  • * The patient is unwilling or unable to comply with the post-operative care instructions
  • * Alcohol, drug, or other subtance abuse
  • * Any disease state that could adversaly affect the function or longevity of the implant
  • * Patient is pregnant
  • * Patient is a prisoner
  • * Patient has a physical or mental condition that would invalidate the results

Ages Eligible for Study

21 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Exactech,

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

Study Record Dates

2034-09-30