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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
100
treatment with open reduction and plates/screws
open reduction and intramedullary nail
reverse total shoulder arthroplasty
UMass Chan Medical School
Worcester, Massachusetts, United States
Range of Motion (ROM)
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)
Time frame: at 3 months, 6 months, 12 months, and 24 months from initiation of treatment
SANE
"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
Time frame: at 3 months, 6 months, 12 months, and 24 months following initiation of treatment
VAS
"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.
Time frame: at 3 months, 6 months, 12 months, and 24 months following initiation of intervention
ASES
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.
Time frame: at 3 months, 6 months, 12 months, and 24 months following initiation of intervention
EQ-5D-5L
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.
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Time frame: at baseline and subsequently at 3 months, 6 months, 12 months, and 24 months following initiation of intervention
Brophy/Marx
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).
Time frame: at baseline and subsequently at 12 months and 24 months after initiation of intervention
PROMIS Social
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.
Time frame: at 3 months, 12 months, and 24 months following initiation of intervention
Radiographic Outcome
evidence of bony healing, nonunion, or malunion of the fracture on imaging
Time frame: at 3 months, 6 months, 12 months, and 24 months following initiation of intervention
Complication Rate
Rate of complications following initiation of management
Time frame: at 3 months, 6 months, 12 months, and 24 months following initiation of intervention