Study on Outcomes of Proximal Humerus Fractures

NCT07060664 | Not Yet Recruiting

• 1 other identifier: 00002567
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Proximal Humerus Fracture

Keywords

proximal humerus fracture; humerus; fracture; shoulder; ORIF; IMN; nail; open reduction internal fixation

Outcome Measures

Primary Outcomes (9)

• 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)

  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

  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.

  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.

  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.

  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).

  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.

  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

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

• Complication Rate

  Rate of complications following initiation of management

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

Study Arms (2)

Operative Management

ACTIVE COMPARATOR

Procedure: open reduction internal fixation; Procedure: intramedullary nail; Procedure: reverse total shoulder arthroplasty

Non-operative Management

NO INTERVENTION

Interventions

open reduction internal fixation PROCEDURE

treatment with open reduction and plates/screws

Also known as: ORIF

Operative Management

intramedullary nail PROCEDURE

open reduction and intramedullary nail

Also known as: IMN

Operative Management

reverse total shoulder arthroplasty PROCEDURE

reverse total shoulder arthroplasty

Also known as: RTSA

Operative Management

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

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

Sponsors & Collaborators

• University of Massachusetts, Worcester: lead

Study Sites (1)

UMass Chan Medical School

Worcester, Massachusetts, 01605, United States

Location

MeSH Terms

Conditions

Fractures, Bone

Interventions

Fracture Fixation, Intramedullary

Condition Hierarchy (Ancestors)

Wounds and Injuries

Intervention Hierarchy (Ancestors)

Fracture Fixation, Internal; Fracture Fixation; Orthopedic Procedures; Therapeutics; Surgical Procedures, Operative

Study Officials

• Wayne Chan, MD

  UMass Chan Medical School

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Gregory Iovanel, MD

CONTACT

401-651-8188; iovanel.gregory@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 29, 2025
• First Posted: July 11, 2025
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): May 1, 2028
• Study Completion (Estimated): July 1, 2028
• Last Updated: October 20, 2025

Record last verified: 2025-10

Locations

US (1)