Conservative vs Surgical Treatment for Proximal Humerus Fractures in the Elderly

Not Applicable

• Conditions: Shoulder Fractures
• Interventions: Procedure: Osteosynthesis with locking plate; Procedure: Sling

• Registration Number: NCT02913378
• Lead Sponsor: University of Sao Paulo

Brief Summary

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.

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2016-01
• Study First Submitted: 2016-09-16
• Study First Submitted QC: 2016-09-21
• Study First Posted: 2016-09-23
• Status Verified: 2017-10
• Last Update Submitted: 2017-10-29
• Last Update Posted: 2017-10-31
• Primary Completion: 2019-07
• Study Completion: 2020-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 58

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Locking plate	Osteosynthesis with locking plate	Surgical treatment with open reduction and osteosynthesis with locking plate
Conservative	Sling	Conservative treatment with sling and rehabilitation

Primary Outcome Measures

Name	Time	Method
Individual relative Constant-Murley score	2 years	Constant-Murley score relative to the unaffected shoulder

Secondary Outcome Measures

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

Trial Locations

Locations (1)

University of Sao Paulo - Department of Orthopedics and Traumatology; 🇧🇷 Sao Paulo, Brazil