Proximal Humerus Fracture
Conditions
Keywords
proximal humerus fracture, humerus, fracture, shoulder, ORIF, IMN, nail, open reduction internal fixation
Brief summary
Patients undergoing either operative or non-operative treatment of proximal humerus fractures will be studied with the goal of understanding which treatment modality provides optimal post-injury outcomes.
Interventions
PROCEDUREopen reduction internal fixation
treatment with open reduction and plates/screws
PROCEDUREintramedullary nail
open reduction and intramedullary nail
PROCEDUREreverse total shoulder arthroplasty
reverse total shoulder arthroplasty
Sponsors
University of Massachusetts, Worcester
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* individuals 65 years of age or older with proximal humerus fractures
Exclusion criteria
\-
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Range of Motion (ROM) | at 3 months, 6 months, 12 months, and 24 months from initiation of treatment | Range of Motion of the shoulder in terms of degrees of motion Assessment of forward flexion (0-180 degrees), abduction (0-90 degrees), external rotation (0-90 degrees) |
| SANE | at 3 months, 6 months, 12 months, and 24 months following initiation of treatment | Sane outcome typically refers to the Single Assessment Numeric Evaluation (SANE) score, a patient-reported outcome measure used in healthcare, particularly in orthopedics. It assesses a patient's perceived function of a joint or body region by asking them to rate it on a scale of 0 to 100, where 100 represents normal function |
| VAS | at 3 months, 6 months, 12 months, and 24 months following initiation of intervention | VAS outcome refers to the results obtained from using a Visual Analog Scale (VAS). The VAS is a measurement tool, typically a 10 cm or 100 mm line, where individuals indicate the intensity of a subjective experience, such as pain, by marking a point on the line. The distance from one end of the line to the patient's mark is then measured, and this measurement represents the VAS score. A higher score indicates a greater intensity of the experience being measured. |
| ASES | at 3 months, 6 months, 12 months, and 24 months following initiation of intervention | The American Shoulder and Elbow Surgeons scale (ASES) is a condition-specific scale that is intended to measure functional limitations and pain of the shoulder. A higher ASES score indicates better shoulder function and less pain, with a score of 100 representing the best possible outcome and a score of 0 representing the worst possible outcome. |
| EQ-5D-5L | at baseline and subsequently at 3 months, 6 months, 12 months, and 24 months following initiation of intervention | The EQ-5D-5L score represents a patient's self-reported health status, with values ranging from -0.59 to 1, where 1 indicates the best possible health. It's based on five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression, each with five levels of severity. These responses are converted into a single index score using a scoring algorithm. |
| Brophy/Marx | at baseline and subsequently at 12 months and 24 months after initiation of intervention | The Brophy-Marx Shoulder Activity Score is a valid and reliable shoulder-specific questionnaire that measures a patient's shoulder activity level over the previous year. The questionnaire generates a numeric score from 0 (least active) to 20 (most active). |
| PROMIS Social | at 3 months, 12 months, and 24 months following initiation of intervention | PROMIS, or the Patient-Reported Outcomes Measurement Information System, uses T-scores to represent social health, with a mean of 50 and a standard deviation of 10 for the general US population. Higher T-scores generally indicate a greater amount of the measured concept, such as satisfaction with social roles and activities, while lower scores indicate less. |
| Radiographic Outcome | at 3 months, 6 months, 12 months, and 24 months following initiation of intervention | evidence of bony healing, nonunion, or malunion of the fracture on imaging |
| Complication Rate | at 3 months, 6 months, 12 months, and 24 months following initiation of intervention | Rate of complications following initiation of management |
Countries
United States
Contacts
Primary ContactGregory Iovanel, MD
Outcome results
None listed