NCT05703958 Exactech Proximal Humerus Fracture Plate System Post Market Clinical Follow-up
| NCT ID | NCT05703958 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Exactech |
| Condition | Proximal Humeral Fracture |
| Study Type | OBSERVATIONAL |
| Enrollment | 151 participants |
| Start Date | 2023-04-19 |
| Primary Completion | 2033-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 151 participants in total. It began in 2023-04-19 with a primary completion date of 2033-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
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
Contact & Investigator
Abhishek Ganta, MD
PRINCIPAL INVESTIGATOR
NYU Langone Health
Frequently Asked Questions
Who can join the NCT05703958 clinical trial?
This trial is open to participants of all sexes, aged 21 Years or older, studying Proximal Humeral Fracture. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05703958 currently recruiting?
Yes, NCT05703958 is actively recruiting participants. Contact the research team at rachael.craig@exac.com for enrollment information.
Where is the NCT05703958 trial being conducted?
This trial is being conducted at New York, United States.
Who is sponsoring the NCT05703958 clinical trial?
NCT05703958 is sponsored by Exactech. The principal investigator is Abhishek Ganta, MD at NYU Langone Health. The trial plans to enroll 151 participants.