Study on Outcomes of Proximal Humerus Fractures

NCT07060664 — Not applicable, Not yet recruiting, 100 participants, University of Massachusetts, Worcester

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Review of Proximal Humerus Fracture Outcomes

RegistryNCT07060664
StatusNot yet recruiting
PhaseNot applicable
Study typeInterventional; non randomized, parallel, masking: none, treatment
Enrollment100 (Estimated)
SponsorUniversity of Massachusetts, Worcester (Other)
ConditionsProximal Humerus Fracture
Interventionsopen reduction internal fixation, intramedullary nail, reverse total shoulder arthroplasty (Procedure)
Datesstart 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
Locations1 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

ArmTypeInterventionsDescription
Operative ManagementActive comparatorProcedure: open reduction internal fixation; Procedure: intramedullary nail; Procedure: reverse total shoulder arthroplasty
Non-operative ManagementNo 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:

\-

+Locations (1)

FacilityCityCountryStatus
UMass Chan Medical SchoolWorcester, MassachusettsUnited States

+Investigators