Influence of Osteoporosis on Clinical Outcomes of Mini-invasive Surgical Treatment of Proximal Humerus Fractures

April 21, 2016 updated by: Riccardo Compagnoni, Azienda Ospedaliera Bolognini di Seriate Bergamo

Aim of the study is to analyze results of treatment of proximal humerus fractures with mini-invasive technique and plate fixation.

In all the patients a analysis of presence of osteoporosis will be done, clinical and x-ray results will be statistically analyzed to evidence any connection between clinical outcomes and osteoporosis.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

65

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients with proximal humerus fracture, treated with a mini-invasive technique plate.

Description

Inclusion Criteria:

  • Proximal humerus fracture

Exclusion Criteria:

  • High risk to surgery (ASA 4 - 5)

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

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
proximal humerus fracture
Patients with proximal humerus fracture treated with mini-invasive plate.
Procedure: proximal humerus fracture fixation
Mini-invasive proximal humerus fixation with plate, patient in beach chair position, general anesthesia, a small incision lateral to shoulder is made to insert the plate under scope control

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
correlate osteoporosis (Cortical index) with clinical (Constant score) and radiological (X-ray) results of the procedure
Time Frame: 30 months average
Osteoporosis will be analyzed with the cortical Index, already described in previous articles about this topic. Clinical evaluation will consider the Constant score, the most used functional score for shoulder. X-ray evaluation will analyze the healing of the fracture, studied by a radiologist, and mobilization of the plate or screws. Data will be combined to analyze correlation between clinical results, plate and screws stability and osteoporosis.
30 months average

Collaborators and Investigators

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

Sponsor

Azienda Ospedaliera Bolognini di Seriate Bergamo

Investigators

  • Study Chair: Carlo Trevisan, Chief, Azienda Ospedaliera Bolognini di Seriate Bergamo

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

April 1, 2016

Primary Completion (Actual)

April 1, 2016

Study Completion (Anticipated)

April 1, 2016

Study Registration Dates

First Submitted

April 19, 2016

First Submitted That Met QC Criteria

April 21, 2016

First Posted (Estimate)

April 26, 2016

Study Record Updates

Last Update Posted (Estimate)

April 26, 2016

Last Update Submitted That Met QC Criteria

April 21, 2016

Last Verified

April 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Trevisan

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

product manufactured in and exported from the U.S.

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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