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

Pseudoarthrosis of the Clavicle Clinical Trial

— CLAPS  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04041258
• Other study ID #: CLAPS
• Status: Terminated
• Phase: N/A
• Start date: July 30, 2019
• Est. completion date: May 1, 2021

Study information

• Verified date: August 2021
• Source: Istituto Ortopedico Rizzoli
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 20
• Est. completion date: May 1, 2021
• Est. primary completion date: July 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Pseudarthrosis
• Pseudoarthrosis of the Clavicle

Intervention

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.

Locations

Country	Name	City	State
Italy	Rizzoli Orthopaedic Institute	Bologna

Sponsors (1)

Lead Sponsor	Collaborator
Istituto Ortopedico Rizzoli

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	range of motion ROM	improvement of range of motion measure (in grade)	at least 1 year of follow up
Primary	presence of dyskinesias	objective clinical evaluation (elevation, external rotation, abduction) with constant scale (0-25 points)	at least 1 year of follow up
Primary	alteration of the clavicle length	measure (mm) obtained from radiographic evaluation	at least 1 year of follow up
Secondary	evaluate shoulder function	improvement in Assessment Shoulder and Elbow Scale (ASES) (0-100 points)	at least 1 year of follow up