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

Sponsor

Istituto Ortopedico Rizzoli (Other)

Overall Status

Terminated

CT.gov ID

NCT04041258

Collaborator

(none)

Enrollment

Location

Arm

21.1

Actual Duration (Months)

0.9

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Pseudoarthrosis of the Clavicle	Procedure: pseudoarthrosis of clavicle	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

20 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Intervention Model Description:

interventional studyinterventional study

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Jul 30, 2019

Actual Primary Completion Date :

Jul 30, 2020

Actual Study Completion Date :

May 1, 2021

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

range of motion ROM [at least 1 year of follow up]
improvement of range of motion measure (in grade)
presence of dyskinesias [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 [at least 1 year of follow up]
measure (mm) obtained from radiographic evaluation

Secondary Outcome Measures

evaluate shoulder function [at least 1 year of follow up]
improvement in Assessment Shoulder and Elbow Scale (ASES) (0-100 points)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Rizzoli Orthopaedic Institute	Bologna		Italy	40136

Sponsors and Collaborators

Istituto Ortopedico Rizzoli

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Istituto Ortopedico Rizzoli

ClinicalTrials.gov Identifier:

NCT04041258

Other Study ID Numbers:

CLAPS

First Posted:

Aug 1, 2019

Last Update Posted:

Apr 15, 2022

Last Verified:

Aug 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Istituto Ortopedico Rizzoli

pseudoarthrosis

clavicle

Additional relevant MeSH terms:

Pseudarthrosis

Study Results

No Results Posted as of Apr 15, 2022