Proximal Humerus Fractures Randomized Control Trial

NCT ID: NCT02362100

Last Updated: 2021-05-17

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-09-30
• Study Completion Date: 2021-01-31

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?

Conditions

Proximal Humerus Fracture

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

nonoperative management

Treatment will consist of sling immobilization for a period of 6 weeks. Details and treatment timeline as follows:

• 0 - 3 weeks: immobilization with a shoulder sling, range of motion of elbow, hand and wrist
• 3 - 6 weeks: same as 0-3 weeks, with addition of pendulum exercises every two hours
• After 6 weeks: Active mobilization and removal of sling. Light activity permitted and physiotherapy for range of motion permitted as tolerated.
• After 6 months: no further restriction will be placed. Full home and work activity permitted.

Group Type: PLACEBO_COMPARATOR

Non operative

Intervention Type: OTHER

non operative treatment

locking plate surgical fixation

Standardized operative management protocol as follows:

• Pre-operative medical clearance established via anesthesia consults if required for medically complex patients.
• Provision of pre-operative intravenous (IV) antibiotic prophylaxis:
• Administration of general anesthetic.
• Patient positioning and preparation:

• Patient is carefully placed in the beach-chair position,
• Deltopectoral approach Fracture reduction and fixation with confirmation with intraoperative fluoroscopy images.

Group Type: ACTIVE_COMPARATOR

locking plate surgical fixation

Intervention Type: PROCEDURE

Interventions

Non operative

non operative treatment

Intervention Type: OTHER

locking plate surgical fixation

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ottawa Hospital Research Institute

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Peter Lapner, MD

Role: PRINCIPAL_INVESTIGATOR

The Ottawa Hospital

Locations

The Ottawa Hospital

Ottawa, Ontario, Canada

Countries

Canada

References

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.

Reference Type: DERIVED

PMID: 35727196 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 30121091 (View on PubMed)

Other Identifiers

20150458-01H

Identifier Type: -

Identifier Source: org_study_id