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Early Fixation for Diaphyseal Humeral Shaft Fractures in the Elderly Patients

F

Fraser Orthopaedic Research Society

Status

Enrolling

Conditions

Elderly (people Aged 65 or More)
Humerus Shaft Fracture

Treatments

Other: Patient Reported Outcome Measures
Other: Range of Motion

Study type

Observational

Funder types

NETWORK

Identifiers

NCT06605482
2024137

Details and patient eligibility

About

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.

Full 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.

Enrollment

94 estimated patients

Sex

All

Ages

65+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

  1. Fractures with intra-articular extension
  2. Ipsilateral upper extremity injury
  3. Patients with vascular injury
  4. Brachial plexus injury
  5. Compartment syndrome
  6. Pathological fractures
  7. Open fractures
  8. Periprosthetic fracture
  9. BMI >40
  10. Dementia or cognitive impairment that inhibits the collection of outcome measures
  11. 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.)
  12. Inability to provide informed consent

Trial design

94 participants in 2 patient groups

Operative
Description:
Humeral shaft fracture is surgically managed with open reduction internal fixation or intramedullary nailing.
Treatment:
Other: Range of Motion
Other: Patient Reported Outcome Measures
Non-operative
Description:
Humeral shaft fracture is conservatively managed with bracing or splinting
Treatment:
Other: Range of Motion
Other: Patient Reported Outcome Measures

Trial contacts and locations

1

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Central trial contact

Bertrand Perey, MD; Kyrsten Butterfield, BSc

Data sourced from clinicaltrials.gov

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