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Recruiting NCT06605482

Early Fixation for Diaphyseal Humeral Shaft Fractures in the Elderly Patients

— Observational Humerus Shaft Fracture Elderly (People Aged 65 or More)

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: Patient Reported Outcome Measures, Range of Motion.
Who it may be relevant to
Registry conditions: Humerus Shaft Fracture, Elderly (People Aged 65 or More). 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
Canada
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

Early Fixation for Diaphyseal Humeral Shaft Fractures in the Elderly Patients: A Prospective Cohort Study

Overview

The study purpose is to evaluate whether early surgical fixation of upper arm fractures in elderly patients' age 65 years and older improves patient functional and psychological outcome scores compared to the standard of care with non-operative management.

Detailed description

A prospective cohort study following patients that are 65 years or older after they have suffered a humeral shaft fracture. Follow up will continue until 1 year post treatment to see functional and psychological outcomes.

Interventions

  • Other Patient Reported Outcome Measures
    Participants will complete the following outcome measures American Shoulder and Elbow Surgeons Evaluation Questionnaire - upper limb function score 12-Item Short Form Survey - general health questionnaire
  • Other Range of Motion
    Shoulder and Elbow Range of Motion collected at the time of radiographic union

Primary outcome measures

  • American Shoulder and Elbow Score [Time frame: Enrolment to 12 months post treatment]
Secondary outcome measures (2)
  • 12-Item Short Form Survey [Time frame: Enrolment to 12 months post treatment]
  • Range of Motion [Time frame: 3 months post treatment]

Eligibility criteria

Inclusion criteria

  • Diaphyseal humeral shaft fracture (as defined as superior border of insertion of pectoralis major proximally, to the distal diaphysis)
  • Ambulatory (with or without the use of walking aides)

Exclusion criteria

  • Fractures with intra-articular extension
  • Ipsilateral upper extremity injury
  • Patients with vascular injury
  • Brachial plexus injury
  • Compartment syndrome
  • Pathological fractures
  • Open fractures
  • Periprosthetic fracture
  • BMI \>40
  • Dementia or cognitive impairment that inhibits the collection of outcome measures
  • Likely problems, in the judgement of the investigator, with maintaining follow-up (i.e. patients with no fixed address, not mentally competent to give consent, intellectually challenged, patients without adequate support, etc.)
  • Inability to provide informed consent

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

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Canada · 1 center
  • Royal Columbian Hospital — New Westminster

Identifiers

NCT: NCT06605482 · 2024137

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗