Long-term follow-up of patients with Proximal Humerus Fracture Plates
An Open Label, Multi-Center, Retrospective and Prospective Evaluation of Equinoxe Proximal Humerus Fracture Plates Clinical and Radiographic Outcomes
This study is tracking patients who have had surgery using a special plate for shoulder fractures to see how well it works and if there are any long-term problems over the next 10 years.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 151 (estimated) |
| Ages | 21 Years and up |
| Sex | All |
| Sponsor | Exactech Industry-sponsored |
| Locations | 1 site (New York, New York) |
| Trial ID | NCT05703958 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include patients who are indicated for or have previously undergone surgery with the Equinoxe Proximal Humerus Fracture Plate and are willing to participate in long-term follow-up.
Not a fit: Patients with conditions such as osteomyelitis, inadequate bone support, or those who are unwilling to comply with postoperative care may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide valuable insights into the long-term effectiveness and safety of the Equinoxe Proximal Humerus Fracture Plates, potentially improving treatment protocols for similar fractures.
How similar studies have performed: While this study focuses on long-term outcomes of a specific device, similar observational studies have shown success in evaluating the effectiveness of orthopedic implants.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
New York, New York
- 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@exac.com
- Phone: 352-377-1140
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.