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Not yet recruiting NCT07060664

Study on Outcomes of Proximal Humerus Fractures

No phase Interventional Proximal Humerus Fracture

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: open reduction internal fixation, intramedullary nail, reverse total shoulder arthroplasty.
Who it may be relevant to
Registry conditions: Proximal Humerus Fracture. Basic parameters: from 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Review of Proximal Humerus Fracture Outcomes

Overview

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.

Interventions

  • Procedure open reduction internal fixation
    treatment with open reduction and plates/screws
  • Procedure intramedullary nail
    open reduction and intramedullary nail
  • Procedure reverse total shoulder arthroplasty
    reverse total shoulder arthroplasty

Primary outcome measures

  • Range of Motion (ROM) [Time frame: at 3 months, 6 months, 12 months, and 24 months from initiation of treatment]
  • SANE [Time frame: at 3 months, 6 months, 12 months, and 24 months following initiation of treatment]
  • VAS [Time frame: at 3 months, 6 months, 12 months, and 24 months following initiation of intervention]
  • ASES [Time frame: at 3 months, 6 months, 12 months, and 24 months following initiation of intervention]
  • EQ-5D-5L [Time frame: at baseline and subsequently at 3 months, 6 months, 12 months, and 24 months following initiation of intervention]
  • Brophy/Marx [Time frame: at baseline and subsequently at 12 months and 24 months after initiation of intervention]
  • PROMIS Social [Time frame: at 3 months, 12 months, and 24 months following initiation of intervention]
  • Radiographic Outcome [Time frame: at 3 months, 6 months, 12 months, and 24 months following initiation of intervention]
  • Complication Rate [Time frame: at 3 months, 6 months, 12 months, and 24 months following initiation of intervention]

Eligibility criteria

Inclusion criteria

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

Exclusion criteria

\-

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Non-randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 1 center
  • UMass Chan Medical School — Worcester

Identifiers

NCT: NCT07060664 · 00002567

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗