"Evaluation of Clinical and Radiographic Results of Pseudarthrosis of Clavicle Treated With Plaque and Screws"
Trial Snapshot
- Phase
- Not Applicable
- Status
- Terminated
- Sponsor
- Istituto Ortopedico Rizzoli
- Enrollment
- 20
- Locations
- 2
- Primary Endpoint
- range of motion ROM
Study 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
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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)