Review of Proximal Humerus Fracture Outcomes
| Registry | NCT07060664 |
| Status | Not yet recruiting |
| Phase | Not applicable |
| Study type | Interventional; non randomized, parallel, masking: none, treatment |
| Enrollment | 100 (Estimated) |
| Sponsor | University of Massachusetts, Worcester (Other) |
| Conditions | Proximal Humerus Fracture |
| Interventions | open reduction internal fixation, intramedullary nail, reverse total shoulder arthroplasty (Procedure) |
| Dates | start 2027-09-01 (estimated), primary completion 2028-05-01 (estimated), completion 2028-07-01 (estimated), first posted 2025-07-11, last updated 2026-10-19 |
| Locations | 1 site in United States |
Related Papers Related Patents Related Grants Related Experts
All trials for Proximal Humerus Fracture All trials of open reduction internal fixation All trials of intramedullary nail
-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.
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+Arms and interventions
| Arm | Type | Interventions | Description |
|---|
| Operative Management | Active comparator | Procedure: open reduction internal fixation; Procedure: intramedullary nail; Procedure: reverse total shoulder arthroplasty | |
| Non-operative Management | No intervention | | |
- open reduction internal fixation (Procedure), also known as ORIF: treatment with open reduction and plates/screws
- intramedullary nail (Procedure), also known as IMN: open reduction and intramedullary nail
- reverse total shoulder arthroplasty (Procedure), also known as RTSA: reverse total shoulder arthroplasty
+Outcome measures
Primary outcomes
- 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
+Eligibility
Sex: All, ages: 65 Years to any
Inclusion Criteria:
* individuals 65 years of age or older with proximal humerus fractures
Exclusion Criteria:
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+Locations (1)
| Facility | City | Country | Status |
|---|
| UMass Chan Medical School | Worcester, Massachusetts | United States | |
+Investigators