Conservative vs Surgical Treatment for Proximal Humerus Fractures in the Elderly

University of Sao Paulo

Status: Unknown

Conditions: Shoulder Fractures

Treatments: Procedure: Sling; Procedure: Osteosynthesis with locking plate

Study type: Interventional

Funder types: Other

Identifiers

NCT02913378

ProxhumerusUSP

Details and patient eligibility

About

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.

Full 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.

Enrollment: 58 estimated patients

Sex: All

Ages: 60+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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58 participants in 2 patient groups

Locking plate

Experimental group

Description:

Surgical treatment with open reduction and osteosynthesis with locking plate

Treatment:

Procedure: Osteosynthesis with locking plate

Conservative

Active Comparator group

Description:

Conservative treatment with sling and rehabilitation

Treatment:

Procedure: Sling