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Conservative vs Surgical Treatment for Proximal Humerus Fractures in the Elderly

NCT ID: NCT02913378

Last Updated: 2017-10-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

58 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-01-31

Study Completion Date

2020-01-31

Brief Summary

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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

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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.

Conditions

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Shoulder Fractures

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Locking plate

Surgical treatment with open reduction and osteosynthesis with locking plate

Group Type EXPERIMENTAL

Osteosynthesis with locking plate

Intervention Type PROCEDURE

Open reduction and osteosynthesis with locking plate

Conservative

Conservative treatment with sling and rehabilitation

Group Type ACTIVE_COMPARATOR

Sling

Intervention Type PROCEDURE

Conservative treatment with sling and rehabilitation

Interventions

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Osteosynthesis with locking plate

Open reduction and osteosynthesis with locking plate

Intervention Type PROCEDURE

Sling

Conservative treatment with sling and rehabilitation

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Sao Paulo

OTHER

Sponsor Role lead

Responsible Party

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Mauro Gracitelli

PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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University of Sao Paulo - Department of Orthopedics and Traumatology

São Paulo, , Brazil

Site Status RECRUITING

Countries

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Brazil

Facility Contacts

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Mauro EC Gracitelli, PhD

Role: primary

Fernando B Andrade-Silva, PhD

Role: backup

References

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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)

Other Identifiers

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ProxhumerusUSP

Identifier Type: -

Identifier Source: org_study_id