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

April 8, 2022 updated by: Istituto Ortopedico Rizzoli
This is an interventional study for clinical and radiographic evaluation of patients operated for pseudoarthrosis of the clavicle

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Actual)

20

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

  • Italy
      • Bologna, Italy, 40136
        • Rizzoli Orthopaedic Institute

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

14 years to 61 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. 18-65 years of pseudarthrosis intervention
  2. Males and Females
  3. Patients treated for pseudoarthrosis of the clavicle between 2007 and 2017 at the Rizzoli Orthopedic Institute

Exclusion Criteria:

  1. Floating shoulder
  2. subjects who present contraindications to radiographic examination at the time of telephone contact

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: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: evaluation of clinical and radiographic findings after surgical treatment
Evaluation of clinical and radiographic findings at least 1 year after surgical treatment for pseudoarthrosis of clavicle
Procedure: pseudoarthrosis of clavicle
Pseudoarthrosis represents a complication following a fracture, resulting in persistent symptoms and functional limitation, which prolongs the recovery time for the patient and necessitates new surgery. The purpose of surgery for pseudoarthrosis is to re-establish the length and alignment of the clavicle in an environment favorable to the union of bone fragments.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
range of motion ROM
Time Frame: at least 1 year of follow up
improvement of range of motion measure (in grade)
at least 1 year of follow up
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)
at least 1 year of follow up
alteration of the clavicle length
Time Frame: at least 1 year of follow up
measure (mm) obtained from radiographic evaluation
at least 1 year of follow up

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
evaluate shoulder function
Time Frame: at least 1 year of follow up
improvement in Assessment Shoulder and Elbow Scale (ASES) (0-100 points)
at least 1 year of follow up

Collaborators and Investigators

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

Sponsor

Istituto Ortopedico Rizzoli

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)

July 30, 2019

Primary Completion (Actual)

July 30, 2020

Study Completion (Actual)

May 1, 2021

Study Registration Dates

First Submitted

July 30, 2019

First Submitted That Met QC Criteria

July 31, 2019

First Posted (Actual)

August 1, 2019

Study Record Updates

Last Update Posted (Actual)

April 15, 2022

Last Update Submitted That Met QC Criteria

April 8, 2022

Last Verified

August 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CLAPS

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

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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