Long-term follow-up of patients with Proximal Humerus Fracture Plates

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study aims to collect and evaluate long-term clinical outcomes data to understand the safety and performance of the Equinoxe Proximal Humerus Fracture Plates over a period of up to 10 years post-surgery. Patients who have received this specific fracture plate or are indicated for its use will be followed to assess their recovery and any complications. The study will involve regular pre- and postoperative visits to ensure compliance and gather comprehensive data on patient outcomes.

Why it matters

Who can join: the full rules

Inclusion 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

Exclusion Criteria:

* 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

Where it's running

• NYU Grossman School of Medicine
  New York, New York, United States Recruiting

Study contacts

• Principal investigator: Abhishek Ganta, MD — NYU Langone Health
• Study coordinator: Rachael Craig
• Email: rachael.craig@advita.com
• Phone: 1-833-423-8482

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.