NCT02750839

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
65

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Apr 2016

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2016

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2016

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

April 19, 2016

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 26, 2016

Completed
Last Updated

April 26, 2016

Status Verified

April 1, 2016

Enrollment Period

Same day

First QC Date

April 19, 2016

Last Update Submit

April 21, 2016

Conditions

OsteoporosisHumerus Fracture

Outcome Measures

Primary Outcomes (1)

  • correlate osteoporosis (Cortical index) with clinical (Constant score) and radiological (X-ray) results of the procedure

    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

Study Arms (1)

proximal humerus fracture

Patients with proximal humerus fracture treated with mini-invasive plate.

Procedure: proximal humerus fracture fixation

Interventions

proximal humerus fracture fixationPROCEDURE

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

proximal humerus fracture

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

  • Proximal humerus fracture

You may not qualify if:

  • High risk to surgery (ASA 4 - 5)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

OsteoporosisHumeral Fractures

Condition Hierarchy (Ancestors)

Bone Diseases, MetabolicBone DiseasesMusculoskeletal DiseasesMetabolic DiseasesNutritional and Metabolic DiseasesArm InjuriesWounds and InjuriesFractures, Bone

Study Officials

  • Carlo Trevisan, Chief

    Azienda Ospedaliera Bolognini di Seriate Bergamo

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Medical doctor

Study Record Dates

First Submitted

April 19, 2016

First Posted

April 26, 2016

Study Start

April 1, 2016

Primary Completion

April 1, 2016

Study Completion

April 1, 2016

Last Updated

April 26, 2016

Record last verified: 2016-04