Study on Outcomes of Proximal Humerus Fractures
This study is looking at different ways to treat a broken upper arm bone near the shoulder (proximal humerus fracture) to see which treatment works best. Researchers are comparing three surgical treatments: open reduction internal fixation (using plates and screws), intramedullary nail (a rod placed inside the bone), and reverse total shoulder arthroplasty (a type of shoulder replacement). The study aims to understand how well each treatment helps with your arm's movement (Range of Motion or ROM), your overall shoulder function (SANE score), and your pain levels (VAS score). You may be able to join if you are 65 years or older and have a proximal humerus fracture. The study is currently unclear on its recruitment status and plans to enroll 100 participants.
- Study design
- This interventional study plans to enroll 100 participants. It is comparing three different surgical procedures for treating proximal humerus fractures.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be followed for 24 months after treatment, with assessments at 3, 6, 12, and 24 months.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Study on Outcomes of Proximal Humerus Fractures
At a glance
Conditions
NCT07060664
Where you'd take part
This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.
UMass Chan Medical School
Worcester, Massachusettsstudy coordinator listed
Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.
Study leadership
- Wayne Chan, MD · PRINCIPAL_INVESTIGATOR · UMass Chan Medical School
Who to contact
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Inclusion
What this trial measures
- 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)
- SANEat 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
- VASat 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.
- ASESat 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-5Lat 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/Marxat 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 Socialat 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 Outcomeat 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 Rateat 3 months, 6 months, 12 months, and 24 months following initiation of intervention
Rate of complications following initiation of management