Clinical trial NCT02362100: Proximal Humerus Fractures Randomized Control Trial
Official title: Proximal Humerus Fractures Randomized Control Trial
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Proximal Humerus Fracture
Lead sponsor: Ottawa Hospital Research Institute
Sponsor class: OTHER
First posted: 2015-02-12
Enrollment: 30
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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?

Eligibility criteria: Inclusion Criteria:

1. Displaced 2- or 3-part proximal humerus fractures by the Neer classification.
2. Displaced 4-part proximal humeral fractures by the Neer classification that are deemed amenable to surgical fixation.
3. \> 60 years of age
4. Low energy mechanism of injury
5. Acute fracture (\<3 weeks)

Exclusion Criteria:

1. 4-part proximal humerus fractures that are not deemed amenable to surgical fixation (eg. due to osteopenic bone, thin head or tuberosity fragments); fractures that are better suited to treatment with arthroplasty
2. Isolated greater tuberosity fractures
3. Ipsilateral upper extremity significant injury, concomitant fracture or polytrauma
4. Open fracture
5. Previous ipsilateral shoulder surgery
6. Patients with active worker's compensation claims (due to the expectation of lower rates of success in this patient population)
7. Active joint or systemic infection
8. Patients with convulsive disorders, collagen diseases, and any other conditions that might affect the mobility of the shoulder joint
9. Major medical illness (life expectancy less than 2 years, unacceptably high operative risk, or not medically cleared by preoperative anesthesia consult)
10. Unable to speak or read English/French
11. Psychiatric illness that precludes informed consent
12. Unwilling to be followed for 2 years

Primary outcomes:
measure: Change in Constant Score
timeFrame: From baseline to up until 24-Months Post-Operative
Secondary outcomes:
measure: Change in American Shoulder and Elbow Surgeons Standardized Shoulder Assessment
timeFrame: From baseline to up until 24-Months Post-Operative
measure: Change in Short Form-36
timeFrame: From baseline to up until 24-Months Post-Operative
Other outcomes:
Locations:
city: Ottawa
country: Canada
facility: The Ottawa Hospital
state: Ontario
Study officials:
affiliation: The Ottawa Hospital
name: Peter Lapner, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Handoll HH, Elliott J, Thillemann TM, Aluko P, Brorson S. Interventions for treating proximal humeral fractures in adults. Cochrane Database Syst Rev. 2022 Jun 21;6(6):CD000434. doi: 10.1002/14651858.CD000434.pub5.
citation: Howard L, Berdusco R, Momoli F, Pollock J, Liew A, Papp S, Lalonde KA, Gofton W, Ruggiero S, Lapner P. Open reduction internal fixation vs non-operative management in proximal humerus fractures: a prospective, randomized controlled trial protocol. BMC Musculoskelet Disord. 2018 Aug 18;19(1):299. doi: 10.1186/s12891-018-2223-3.