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NCT06605482 | NOT YET RECRUITING | Humerus Shaft Fracture


Early Fixation for Diaphyseal Humeral Shaft Fractures in the Elderly Patients
Sponsor:

Fraser Orthopaedic Research Society

Brief Summary:

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.

Condition or disease

Humerus Shaft Fracture

Elderly (people Aged 65 or More)

Intervention/treatment

Patient Reported Outcome Measures

Range of Motion

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.

Study Type : OBSERVATIONAL
Estimated Enrollment : 94 participants
Official Title : Early Fixation for Diaphyseal Humeral Shaft Fractures in the Elderly Patients: a Prospective Cohort Study
Actual Study Start Date : 2024-12-01
Estimated Primary Completion Date : 2027-09-30
Estimated Study Completion Date : 2027-12-31

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 65 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
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

Early Fixation for Diaphyseal Humeral Shaft Fractures in the Elderly Patients

Location Details

NCT06605482


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