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NCT Number: NCT06605482

Early Fixation for Diaphyseal Humeral Shaft Fractures in the Elderly Patients

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.

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Key information

Conditions

Humerus Shaft Fracture Elderly (People Aged 65 or More)

Age range

65 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Royal Columbian Hospital

New Westminster, British Columbia, V3L 3W7, Canada

Location status: Recruiting

Location contact

Bertrand Perey, MD

PRINCIPAL_INVESTIGATOR

Kyrsten D Butterfield, BSc

CONTACT

[email protected]

6045533247

Manuja M Annthakumar, BSc

CONTACT

[email protected]

6045533247

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Patient Reported Outcome Measures

Other

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

Range of Motion

Other

Shoulder and Elbow Range of Motion collected at the time of radiographic union

Primary outcomes

  1. American Shoulder and Elbow Score

    Time frame: Enrolment to 12 months post treatment

    Patient reported outcome measure for shoulder and elbow function. The score ranges from 0 to 100, with 0 the lowest level of function and 100 the highest level of function.

Secondary outcomes

  1. 12-Item Short Form Survey

    Time frame: Enrolment to 12 months post treatment

    General health patient reported outcome measure. Scores range from 0 to 100, with higher scores indicating better physical and mental health functioning.

  2. Range of Motion

    Time frame: 3 months post treatment

    range of motion of shoulder and elbow

Study contacts

Contact information is provided by the study sponsor or research team.

Bertrand Perey, MD

CONTACT

[email protected]

604-553-3247

Kyrsten Butterfield, BSc

CONTACT

[email protected]

604-553-3247

Sponsors and collaborators

Lead sponsor

Fraser Orthopaedic Research Society

Network

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Sep 20, 2024
Registry last updated
Feb 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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