Conservative Treatment of Proximal Humeral Fractures

NCT ID: NCT03217344

Last Updated: 2019-03-12

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

COMPLETED

Clinical Phase

NA

Total Enrollment

130 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-10-19

Study Completion Date

2018-06-20

Brief Summary

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Optimal treatment of proximal humeral fractures is yet to be defined. Many of them can be treated non-operatively. The question remains on how long do we have to immobilize non-operatively treated proximal humeral fractures?

Detailed Description

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There is still controversy on best treatment of proximal humeral fractures. While some authors propose surgical treatment other advocate for conservative treatment. Traditionally, fractures treated non-operatively undergo a 3-week period of immobilization followed by progressive rehabilitation program. Nevertheless, there is little evidence to support a 3-week immobilization period. The purpose of this study is to bring evidence to support either a 1-week immobilization or 3-week immobilization period in non-operatively treated proximal humeral fractures.

Conditions

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Shoulder Fractures

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

prospective randomized without restrictions
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1-week

patients undergoing 1-week immobilization period

Group Type EXPERIMENTAL

conservative treatment

Intervention Type PROCEDURE

immobilization on sling of the injured arm

3-week

patients undergoing 3-week immobilization period

Group Type EXPERIMENTAL

conservative treatment

Intervention Type PROCEDURE

immobilization on sling of the injured arm

Interventions

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conservative treatment

immobilization on sling of the injured arm

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Patients ≥ 60 yo and \< 85 yo
* Acute fractures less than 1 week evolution
* Conservative treatment decided by orthopedic surgeon
* Contact between humeral head and humeral shaft.
* No gleno-humeral dislocation
* No previous surgery

Exclusion Criteria

* Cognitive impairment
Minimum Eligible Age

60 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hospital del Mar

OTHER

Sponsor Role lead

Responsible Party

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Carlos Torrens

Medical Doctor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Carlos Torrens, PhD

Role: PRINCIPAL_INVESTIGATOR

Hospital Mar

Locations

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Carlos Torrens

Barcelona, , Spain

Site Status

Countries

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Spain

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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2016/6588/I

Identifier Type: -

Identifier Source: org_study_id

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