Health TrialsbyHealthPanel

Early Fixation for Diaphyseal Humeral Shaft Fractures in the Elderly Patients

ConditionsHumerus Shaft FractureElderly (People Aged 65 or More)
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age65+
SponsorFraser Orthopaedic Research Society

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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)

Disqualifiers

Fractures with intra-articular extension

Ipsilateral upper extremity injury

Patients with vascular injury

Brachial plexus injury

Trial population

Patients who present to the Royal Columbian Hospital or the investigators clinic with a diaphysial humeral shaft fracture.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Patient Reported Outcome Measures

    Other intervention

    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 intervention

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

Treatment groups

94 Participants
are divided into 2 treatment groups
Group A: Operative2 interventions
Group B: Non-operative2 interventions

Trial outcomes

Primary outcomes

1

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

1

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
2

Range of Motion

range of motion of shoulder and elbow

Time frame
3 months post treatment

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Fraser Orthopaedic Research Society

Lead sponsor

Source ClinicalTrials.gov
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