Early Fixation for Diaphyseal Humeral Shaft Fractures in the Elderly Patients

Fraser Orthopaedic Research Society94 enrolled

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.

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

Enrollment

Conditions

Humerus Shaft Fracture Elderly (People Aged 65 or More)

Interventions

Patient Reported Outcome MeasuresOTHER

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 MotionOTHER

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

Eligibility

Sex: ALLMin age: 65 Years

Medical Language ↔ Plain English

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 \&gt;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

Locations (1)

Royal Columbian Hospital

New Westminster, British Columbia, Canada

RECRUITING

Outcomes

Primary Outcomes

American Shoulder and Elbow Score

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.

Time frame: Enrolment to 12 months post treatment

Secondary Outcomes

12-Item Short Form Survey

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

Time frame: Enrolment to 12 months post treatment

Range of Motion

range of motion of shoulder and elbow

Time frame: 3 months post treatment

Central Contacts

Kyrsten Butterfield, BSc

CONTACT

604-553-3247 kyrsten.butterfield@fraserhealth.ca

Bertrand Perey, MD

CONTACT

604-553-3247 bperey@shaw.ca

Data from ClinicalTrials.gov

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