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Clinical Trials/NCT04041258
NCT04041258
Terminated
N/A

"Evaluation of Clinical and Radiographic Results of Pseudarthrosis of Clavicle Treated With Plaque and Screws"

Istituto Ortopedico Rizzoli1 site in 1 country20 target enrollmentJuly 30, 2019

Overview

Phase
N/A
Intervention
Not specified
Conditions
Pseudoarthrosis of the Clavicle
Sponsor
Istituto Ortopedico Rizzoli
Enrollment
20
Locations
1
Primary Endpoint
range of motion ROM
Status
Terminated
Last Updated
4 years ago

Overview

Brief Summary

This is an interventional study for clinical and radiographic evaluation of patients operated for pseudoarthrosis of the clavicle

Detailed Description

The aim of our study is to collect clinical and radiographic data from patients operated for pseudoarthrosis of the clavicle from 2007 to 2017 at the Rizzoli Orthopedic Institute, in order to evaluate the clinical and radiographic results of the treatment. This is an interventional study and patients will be contacted by telephone to verify their willingness to perform a visit (including a bilateral radiographic) at the Rizzoli Orthopedic Institute

Registry
clinicaltrials.gov
Start Date
July 30, 2019
End Date
May 1, 2021
Last Updated
4 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • 18-65 years of pseudarthrosis intervention
  • Males and Females
  • Patients treated for pseudoarthrosis of the clavicle between 2007 and 2017 at the Rizzoli Orthopedic Institute

Exclusion Criteria

  • Floating shoulder
  • subjects who present contraindications to radiographic examination at the time of telephone contact

Outcomes

Primary Outcomes

range of motion ROM

Time Frame: at least 1 year of follow up

improvement of range of motion measure (in grade)

presence of dyskinesias

Time Frame: at least 1 year of follow up

objective clinical evaluation (elevation, external rotation, abduction) with constant scale (0-25 points)

alteration of the clavicle length

Time Frame: at least 1 year of follow up

measure (mm) obtained from radiographic evaluation

Secondary Outcomes

  • evaluate shoulder function(at least 1 year of follow up)

Study Sites (1)

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