An interventional study of open reduction internal fixation and intramedullary nail in Proximal Humerus Fracture, sponsored by University of Massachusetts, Worcester. Not yet recruiting at 1 site in United States. Open to participants aged 65 Years and older. Per ClinicalTrials.gov, last updated 2026-10-19.
Sponsored by University of Massachusetts, Worcester · Not applicable, Interventional, and Treatment
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.
723 studies on the registry are indexed under Fractures, Bone; 114 are open to participants now.
This study's planned enrollment of 100 is above the median of 80 across 458 interventional studies indexed under Fractures, Bone.
Browse Fractures, Bone studies →University of Massachusetts, Worcester is the lead sponsor of 291 studies on the registry; 51 are open to participants now.
Of its 25 completed or terminated interventional studies of FDA-regulated products, 18 (72%) have results posted.
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Exclusion Criteria:
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Procedure: open reduction internal fixation · Procedure: intramedullary nail · Procedure: reverse total shoulder arthroplasty
treatment with open reduction and plates/screws
Also known as: ORIF
open reduction and intramedullary nail
Also known as: IMN
reverse total shoulder arthroplasty
Also known as: RTSA
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.
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
Plan to share: Undecided
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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