Proximal Humerus Fractures Randomized Control Trial

NCT02362100 | Terminated DMC

• 1 other identifier: 20150458-01H
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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 .

Conditions

Proximal Humerus Fracture

Outcome Measures

Primary Outcomes (1)

• Change in Constant Score

  The Constant Score reflects an overall clinical functional assessment. This instrument is based on a 100-point scoring system. Subjective findings (pain, activities of daily living, and working in different positions) make up a total of 35 points. Objective measurements make up the remaining 65 points.The test is divided into four sub-categories: (1) pain is measured using 4 likert levels (15 points maximum), where a higher score indicates a better outcome; activities of daily living are measured using a likert scale, where a higher number indicates better outcomes (20 points maximum); mobility is measured by an assessor, and rated using a likert scale where a higher score indicates better outcomes (40 points maximum); finally, strength is measured by an assessor where 1 point is given per 0.5kg of force (maximum 25 points), a higher score indicates better outcomes. All categories are added together, and a total score out of 100 is given (higher score indicates better outcome).

  From baseline to up until 24-Months Post-Operative

Secondary Outcomes (2)

• Change in American Shoulder and Elbow Surgeons Standardized Shoulder Assessment

  From baseline to up until 24-Months Post-Operative

• Change in Short Form-36

  From baseline to up until 24-Months Post-Operative

Study Arms (2)

nonoperative management

PLACEBO COMPARATOR

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.

Other: Non operative

locking plate surgical fixation

ACTIVE COMPARATOR

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.

Procedure: locking plate surgical fixation

Interventions

Non operative OTHER

non operative treatment

nonoperative management

locking plate surgical fixation PROCEDURE

locking plate surgical fixation

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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
• Isolated greater tuberosity fractures
• Ipsilateral upper extremity significant injury, concomitant fracture or polytrauma
• Open fracture
• Previous ipsilateral shoulder surgery
• Patients with active worker's compensation claims (due to the expectation of lower rates of success in this patient population)
• Active joint or systemic infection
• Patients with convulsive disorders, collagen diseases, and any other conditions that might affect the mobility of the shoulder joint
• Major medical illness (life expectancy less than 2 years, unacceptably high operative risk, or not medically cleared by preoperative anesthesia consult)
• Unable to speak or read English/French
• Psychiatric illness that precludes informed consent
• Unwilling to be followed for 2 years

Sponsors & Collaborators

• Ottawa Hospital Research Institute: lead

Study Sites (1)

The Ottawa Hospital

Ottawa, Ontario, K1H8L6, Canada

Location

Related Publications (2)

• 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.

  PMID: 35727196 DERIVED

• 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.

  PMID: 30121091 DERIVED

Study Officials

• Peter Lapner, MD

  The Ottawa Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 8, 2015
• First Posted: February 12, 2015
• Study Start: September 1, 2015
• Primary Completion: January 1, 2021
• Study Completion: January 1, 2021
• Last Updated: May 17, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)