Conservative Treatment of Proximal Humeral Fractures

March 10, 2019 updated by: Carlos Torrens, Hospital del Mar

Conservative Treatment of Proximal Humeral Fractures - Immobilization for 1 Week Compared to Three Weeks: Prospective Randomized Study

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?

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

130

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Barcelona, Spain, 08003
        • Carlos Torrens

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

60 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1-week
patients undergoing 1-week immobilization period
Procedure: conservative treatment
immobilization on sling of the injured arm
Experimental: 3-week
patients undergoing 3-week immobilization period
Procedure: conservative treatment
immobilization on sling of the injured arm

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
pain (analogical pain scale)
Time Frame: 1 year
pain assessment through all the follow-up through the analogical pain scale
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
fragment displacement assessed through X-Ray exam
Time Frame: 3 months
displacement of the fractured fragments within 3 months period assessed through X-Ray exam
3 months
functional outcome
Time Frame: 1 year
functional outcome measured through Constant Score
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital del Mar

Investigators

  • Principal Investigator: Carlos Torrens, PhD, Hospital Mar

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 19, 2015

Primary Completion (Actual)

June 20, 2018

Study Completion (Actual)

June 20, 2018

Study Registration Dates

First Submitted

July 4, 2017

First Submitted That Met QC Criteria

July 11, 2017

First Posted (Actual)

July 14, 2017

Study Record Updates

Last Update Posted (Actual)

March 12, 2019

Last Update Submitted That Met QC Criteria

March 10, 2019

Last Verified

March 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2016/6588/I

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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