NCT02362100

Proximal Humerus Fractures Randomized Control Trial

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Ottawa Hospital Research Institute · Academic / Other
• Sex: All
• Age: 60 Years
• Healthy volunteers: Not accepted

Summary

The primary objective is to determine if a difference exists in functional outcomes, as measured by the Constant score, when comparing nonoperative management and locking plate surgical fixation of low-energy displaced proximal humerus fractures in the elderly population over a 2-year follow-up period. Secondary outcomes will include an assessment of the ASES score, the SF-36 quality of life score, complication rates, re-operation rates, radiographic time to union, radiographic malunion, hardware position and evidence of avascular necrosis or posttraumatic osteoarthritis .

Detailed description

The design of this study is two-fold. The main study will be a prospective, single blind, randomized controlled trial (RCT). Patients will be randomized to either (1) non-operative treatment or (2) locking plate open reduction and internal fixation (ORIF). The second component of this study will be a prospective, cohort study. This option will be presented to patients who do not want to enroll in the RCT because they prefer one treatment option over the other, and do not wish to be randomized to a treatment. Patients who choose either non-operative treatment or ORIF for their proximal humerus fracture will be followed for 2 years post injury. Study Objectives: Objective 1: Does a difference exist in the functional outcome between non-operative management and locking plate surgical fixation of low-energy displaced two-part, three-part, and four-part proximal humerus fractures in the elderly population based on the Constant functional outcome score over a 2-year follow-up period? Objective 2: Does a difference exist between non-operative management and locking plate surgical fixation of low-energy displaced two-part, three-part, and four-part proximal humerus fractures in the elderly population based on the ASES functional outcome score, the short form Patient Reported Outcomes Measurement Information System (PROMIS) upper extremity score, the International Physical Activity Questionnaire (IPAQ) for the elderly, and the EuroQol EQ-5D-5L Health Questionnaire Quality of Life (QoL) functional outcome score over a 2-year follow-up period? What is the incidence of complications of non-operative management and locking plate surgical fixation of low-energy displaced two-part, three-part, and four-part proximal humerus fractures in the elderly population based on infection, nerve injury, intra-articular screw penetration and bleeding (hematoma), reoperation rate, or hospital readmission over a 2-year follow-up period? Objective 3: Does a difference exist between non-operative management and locking plate surgical fixation of low-energy displaced two-part, three-part, and four-part proximal humerus fractures in the elderly population based on radiographic outcomes including non-union, malunion, and joint arthrosis? Objective 4: Does the degree of initial displacement or angulation of the fracture fragments correlate with final functional outcome measures? Objective 5: Does the quality of the surgical reduction correlate with final functional outcome measures?

Conditions

• Proximal Humerus Fracture

Interventions

Type	Name	Description
OTHER	Non operative	non operative treatment
PROCEDURE	locking plate surgical fixation

Timeline

• Start date: 2015-09-01
• Primary completion: 2021-01-01
• Completion: 2021-01-01
• First posted: 2015-02-12
• Last updated: 2021-05-17

Locations

1 site across 1 country: Canada