Back to results"Evaluation of Clinical and Radiographic Results of Pseudarthrosis of Clavicle Treated With Plaque and Screws" (CLAPS)
Primary Purpose
Pseudoarthrosis of the Clavicle
Status
Terminated
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
pseudoarthrosis of clavicle
Sponsored by
About this trial
This is an interventional treatment trial for Pseudoarthrosis of the Clavicle focused on measuring pseudoarthrosis, clavicle
Eligibility Criteria
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
Sites / Locations
- Rizzoli Orthopaedic Institute
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
evaluation of clinical and radiographic findings after surgical treatment
Arm Description
Evaluation of clinical and radiographic findings at least 1 year after surgical treatment for pseudoarthrosis of clavicle
Outcomes
Primary Outcome Measures
range of motion ROM
improvement of range of motion measure (in grade)
presence of dyskinesias
objective clinical evaluation (elevation, external rotation, abduction) with constant scale (0-25 points)
alteration of the clavicle length
measure (mm) obtained from radiographic evaluation
Secondary Outcome Measures
evaluate shoulder function
improvement in Assessment Shoulder and Elbow Scale (ASES) (0-100 points)
Full Information
NCT ID
NCT04041258
First Posted
July 30, 2019
Last Updated
April 8, 2022
Sponsor
Istituto Ortopedico Rizzoli
1. Study Identification
Unique Protocol Identification Number
NCT04041258
Brief Title
"Evaluation of Clinical and Radiographic Results of Pseudarthrosis of Clavicle Treated With Plaque and Screws"
Acronym
CLAPS
Official Title
"Evaluation of Clinical and Radiographic Results of Pseudarthrosis of Clavicle Treated With Plaque and Screws"
Study Type
Interventional
2. Study Status
Record Verification Date
August 2021
Overall Recruitment Status
Terminated
Why Stopped
the number of patients was not sufficient to support continuation of the study
Study Start Date
July 30, 2019 (Actual)
Primary Completion Date
July 30, 2020 (Actual)
Study Completion Date
May 1, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Istituto Ortopedico Rizzoli
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pseudoarthrosis of the Clavicle
Keywords
pseudoarthrosis, clavicle
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
interventional study
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
evaluation of clinical and radiographic findings after surgical treatment
Arm Type
Experimental
Arm Description
Evaluation of clinical and radiographic findings at least 1 year after surgical treatment for pseudoarthrosis of clavicle
Intervention Type
Procedure
Intervention Name(s)
pseudoarthrosis of clavicle
Intervention Description
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.
Primary Outcome Measure Information:
Title
range of motion ROM
Description
improvement of range of motion measure (in grade)
Time Frame
at least 1 year of follow up
Title
presence of dyskinesias
Description
objective clinical evaluation (elevation, external rotation, abduction) with constant scale (0-25 points)
Time Frame
at least 1 year of follow up
Title
alteration of the clavicle length
Description
measure (mm) obtained from radiographic evaluation
Time Frame
at least 1 year of follow up
Secondary Outcome Measure Information:
Title
evaluate shoulder function
Description
improvement in Assessment Shoulder and Elbow Scale (ASES) (0-100 points)
Time Frame
at least 1 year of follow up
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Rizzoli Orthopaedic Institute
City
Bologna
ZIP/Postal Code
40136
Country
Italy
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
"Evaluation of Clinical and Radiographic Results of Pseudarthrosis of Clavicle Treated With Plaque and Screws"
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