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NCT Number: NCT07060664

Study on Outcomes of Proximal Humerus Fractures

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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Key information

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UMass Chan Medical School

Worcester, Massachusetts, 01605, United States

Location contact

Gregory Iovanel, MD

CONTACT

[email protected]

401-651-8188

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • individuals 65 years of age or older with proximal humerus fractures

Exclusion criteria

-

Treatment and study plan

Open reduction internal fixation

Procedure

treatment with open reduction and plates/screws

Other names: ORIF

Intramedullary nail

Procedure

open reduction and intramedullary nail

Other names: IMN

Reverse Total Shoulder Arthroplasty

Procedure

reverse total shoulder arthroplasty

Other names: RTSA

Primary outcomes

  1. Range of Motion (ROM)

    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)

  2. SANE

    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

  3. VAS

    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.

  4. ASES

    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.

  5. EQ-5D-5L

    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.

  6. Brophy/Marx

    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).

  7. PROMIS Social

    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.

  8. Radiographic Outcome

    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

  9. Complication Rate

    Time frame: at 3 months, 6 months, 12 months, and 24 months following initiation of intervention

    Rate of complications following initiation of management

Study contacts

Contact information is provided by the study sponsor or research team.

Gregory Iovanel, MD

CONTACT

[email protected]

401-651-8188

Sponsors and collaborators

Lead sponsor

University of Massachusetts, Worcester

Other

Registry information

Official study title

Review of Proximal Humerus Fracture Outcomes

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Jul 11, 2025
Registry last updated
Oct 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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