Fracture Dislocation, Non-Union Fracture, Proximal Humeral Fracture
Conditions
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.
Interventions
None listed
Sponsors
Exactech
Study design
Observational model
COHORT
Time perspective
OTHER
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Smart Score | Through study completion, an average of 1 per year | Shoulder Arthroplasty Smart (SAS) score - 6 questions based on 3 objective active range of motion and 3 subjective measures of pain and function. Score range of 0 to 100 where 100 indicates the best score |
| Sane Score | Through study completion, an average of 1 per year | Single Assessment Numeric Evaluation (SANE) - Patient shoulder self-evaluation as a percentage of normal, 100% corresponds being normal |
| ASES | Through study completion, an average of 1 per year | American Shoulder and Elbow Surgeons Score (ASES) - 100 points scale about shoulder pain and performance evaluation in activities of daily living where 100 indicates the best shoulder condition |
| Quick DASH | Through study completion, an average of 1 per year | Shorten version of Disability of the Arm, Shoulder, and Hand (DASH) - 11 items to measure ability of a patient to perform certain upper extremity where 0 corresponds to no difficulty and 100 corresponds to unable |
Countries
United States
Contacts
CONTACTRachael Craig
CONTACTSandrine Angibaud
PRINCIPAL_INVESTIGATORAbhishek Ganta, MD
NYU Langone Health
Outcome results
None listed