Exactech Proximal Humerus Fracture Plate System Post Market Clinical Follow-up
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.
| Condition(s) | Proximal Humeral Fracture, Fracture Dislocation, Non-Union Fracture |
|---|---|
| Status | Recruiting |
| Study type | Observational |
| 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. |
| Who can participate | 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 in |
| Ages | 21 Years |
| Sex | All |
| Lead sponsor | Exactech |
| Locations | New York, New York, United States |
| Start date | 2023-04-19 |
| NCT ID | NCT05703958 |
| Official listing | https://clinicaltrials.gov/study/NCT05703958 |