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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.
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| Measure | Description | Time Frame |
|---|---|---|
| Smart Score | 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 | Through study completion, an average of 1 per year |
| Sane Score | Single Assessment Numeric Evaluation (SANE) - Patient shoulder self-evaluation as a percentage of normal, 100% corresponds being normal | Through study completion, an average of 1 per year |
| ASES | 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 | Through study completion, an average of 1 per year |
| Quick DASH | 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 | Through study completion, an average of 1 per year |
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Inclusion Criteria:
Exclusion Criteria:
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Patients undergoing ORIF surgery who meet eligibility criteria - Patients who consent to participate to return for follow-up visits out to 10 years or longer
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Rachael Craig | Contact | 352-377-1140 | rachael.craig@exac.com | |
| Sandrine Angibaud | Contact | 352-377-1140 | sandrine.angbaud@exac.com |
| Name | Affiliation | Role |
|---|---|---|
| Abhishek Ganta, MD | NYU Langone Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| NYU Grossman School of Medicine | Recruiting | New York | New York | 10016 | United States |
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| ID | Term |
|---|---|
| D012784 | Shoulder Fractures |
| D000072039 | Fracture Dislocation |
| D005599 | Fractures, Ununited |
| ID | Term |
|---|---|
| D050723 | Fractures, Bone |
| D014947 | Wounds and Injuries |
| D000070599 | Shoulder Injuries |
| D004204 | Joint Dislocations |
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| D007592 |
| Joint Diseases |
| D009140 | Musculoskeletal Diseases |