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

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ClinicalTrials.gov Identifier: NCT02750839
Recruitment Status : Unknown
Verified April 2016 by Riccardo Compagnoni, Azienda Ospedaliera Bolognini di Seriate Bergamo.
Recruitment status was:  Enrolling by invitation
First Posted : April 26, 2016
Last Update Posted : April 26, 2016
Sponsor:
Information provided by (Responsible Party):
Riccardo Compagnoni, Azienda Ospedaliera Bolognini di Seriate Bergamo

Brief Summary:

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.


Condition or disease Intervention/treatment
Osteoporosis Humerus Fracture Procedure: proximal humerus fracture fixation

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Study Type : Observational
Actual Enrollment : 65 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Influence of Osteoporosis on Clinical Outcomes of Mini-invasive Surgical Treatment of Proximal Humerus Fractures
Study Start Date : April 2016
Actual Primary Completion Date : April 2016
Estimated Study Completion Date : April 2016

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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




Primary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients with proximal humerus fracture, treated with a mini-invasive technique plate.
Criteria

Inclusion Criteria:

  • Proximal humerus fracture

Exclusion Criteria:

  • High risk to surgery (ASA 4 - 5)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02750839


Sponsors and Collaborators
Azienda Ospedaliera Bolognini di Seriate Bergamo
Investigators
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Study Chair: Carlo Trevisan, Chief Azienda Ospedaliera Bolognini di Seriate Bergamo

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Responsible Party: Riccardo Compagnoni, Medical doctor, Azienda Ospedaliera Bolognini di Seriate Bergamo
ClinicalTrials.gov Identifier: NCT02750839     History of Changes
Other Study ID Numbers: Trevisan
First Posted: April 26, 2016    Key Record Dates
Last Update Posted: April 26, 2016
Last Verified: April 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Additional relevant MeSH terms:
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Osteoporosis
Fractures, Bone
Humeral Fractures
Wounds and Injuries
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Metabolic Diseases
Arm Injuries