Conservative vs Surgical Treatment for Proximal Humerus Fractures in the Elderly

Conservative Treatment vs Locked Plate Osteosynthesis for Proximal Humerus Fractures in the Elderly: a Randomized Controlled Trial

This is a randomized trial comparing conservative with surgical treatment (with open reduction and locking plate fixation) for proximal humeral fractures in patients aged more than 60 years.

Study Overview

• Status: Unknown
• Conditions: Shoulder Fractures
• Intervention / Treatment: Procedure: Osteosynthesis with locking plate; Procedure: Sling

Detailed Description

Different methods have been used in the treatment of proximal humeral fractures. Usually, treatment choice depends on fracture displacement, patient age, osteoporosis, and other characteristics. Locking plate fixation has become the most widely used method among surgical techniques, while partial arthroplasty is reserved for older patients and comminuted articular fractures. Generally, nonsurgical treatment involves a brief period with sling immobilization and physiotherapy rehabilitation.

A recent multicenter study showed no difference between conservative and surgical treatments, including internal fixation with locking plates. Two other randomized studies showed mixed results, with no relevant clinical differences between the methods. No previous trial has evaluated the quality of reduction in surgically treated fractures and its relation to outcomes. Our study aims to compare both techniques with a detailed radiographic and tomographic evaluation, in elderly patients. We also aim to evaluate the influence of reduction and plate positioning on clinical outcomes. This is a single center trial, in which surgeries will be performed by only two experienced surgeons.

• Study Type: Interventional
• Enrollment (Anticipated): 58
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • Sao Paulo, Brazil, 05403-010
    • Recruiting
    • University of Sao Paulo - Department of Orthopedics and Traumatology
    • Contact: Mauro EC Gracitelli, PhD; Phone Number: +5511 983052345; Email: mgracitelli@gmail.com
    • Contact: Fernando B Andrade-Silva, PhD; Phone Number: + 55 11 983729983; Email: fbrandao86@yahoo.com.br
    • Principal Investigator: Fernando B Andrade-Silva, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Proximal humeral fractures, involving humeral head, with at least one of the following parameters:
• Head-shaft angle between 100-200° or >175° on coronal plane;
• Shaft translation (on coronal or sagittal plane) > 1cm;
• Tuberosity displacement > 0,5cm;
• Head shaft angulation >45° in axial or sagittal plane;
• Less then 30 days

Exclusion Criteria:

• No contact between shaft and humeral head
• Head-shaft angle <100° on coronal plane
• Articular head fracture with displacement > 2mm
• Fracture-dislocation
• Bilateral fracture
• Open fracture
• Ipsilateral or contralateral superior limb fracture
• Pathological fracture (tumors or bone disease, except for osteoporosis)
• Previous rotator cuff complete tear
• Previous infection
• Neurological injury
• Previous shoulder surgery
• Inability to answer subjective scores

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Locking plate; Surgical treatment with open reduction and osteosynthesis with locking plate	Procedure: Osteosynthesis with locking plate; Open reduction and osteosynthesis with locking plate
Active Comparator: Conservative; Conservative treatment with sling and rehabilitation	Procedure: Sling; Conservative treatment with sling and rehabilitation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Individual relative Constant-Murley score	Constant-Murley score relative to the unaffected shoulder	2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
American Shoulder and Elbow Surgeons Shoulder (ASES) score	Subjective functional evaluation	2 years
Constant-Murley score		2 years
12-Item Short Form Health Survey (SF-12)	Quality of life evaluation	2 years
Visual analog scale (VAS) for pain		2 years
Complication and reoperation rate		2 years
Radiographic evaluation	Union, head-shaft angle, tuberosities reduction, medial support and Fjalestad reduction criteria	2 years
Rotator cuff ultrasound and magnetic resonance		2 years

Collaborators and Investigators

• Sponsor: University of Sao Paulo

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: January 1, 2016
• Primary Completion (Anticipated): July 1, 2019
• Study Completion (Anticipated): January 1, 2020

Study Registration Dates

• First Submitted: September 16, 2016
• First Submitted That Met QC Criteria: September 21, 2016
• First Posted (Estimate): September 23, 2016

Study Record Updates

• Last Update Posted (Actual): October 31, 2017
• Last Update Submitted That Met QC Criteria: October 29, 2017
• Last Verified: October 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Shoulder Injuries; Arm Injuries; Fractures, Bone; Humeral Fractures; Shoulder Fractures
• Other Study ID Numbers: ProxhumerusUSP

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED