UMass Chan Medical School
Worcester, Massachusetts, 01605, United States
NCT Number: NCT07060664
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.
Trial opening soon.
Get Notified65 year and older
All sexes
Interventional
Not applicable
Worcester, Massachusetts, 01605, United States
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
-
treatment with open reduction and plates/screws
Other names: ORIF
open reduction and intramedullary nail
Other names: IMN
reverse total shoulder arthroplasty
Other names: RTSA
Time frame: 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)
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: 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.
Time frame: 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
Time frame: at 3 months, 6 months, 12 months, and 24 months following initiation of intervention
Rate of complications following initiation of management
Contact information is provided by the study sponsor or research team.
University of Massachusetts, Worcester
Other
Review of Proximal Humerus Fracture Outcomes
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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