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

Not Applicable

Terminated

• Conditions: Pseudoarthrosis of the Clavicle
• Interventions: Procedure: pseudoarthrosis of clavicle

• Registration Number: NCT04041258
• Lead Sponsor: Istituto Ortopedico Rizzoli

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

Study Timeline

• Study Start: 2019-07-30
• Study First Submitted: 2019-07-30
• Study First Submitted QC: 2019-07-31
• Study First Posted: 2019-08-01
• Primary Completion: 2020-07-30
• Study Completion: 2021-05-01
• Status Verified: 2021-08
• Last Update Submitted: 2022-04-08
• Last Update Posted: 2022-04-15

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 20

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
evaluation of clinical and radiographic findings after surgical treatment	pseudoarthrosis of clavicle	Evaluation of clinical and radiographic findings at least 1 year after surgical treatment for pseudoarthrosis of clavicle

Primary Outcome Measures

Name	Time	Method
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

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

Trial Locations

Locations (1)

Rizzoli Orthopaedic Institute; 🇮🇹 Bologna, Italy