An interventional study of pseudoarthrosis of clavicle in Pseudoarthrosis of the Clavicle, sponsored by Istituto Ortopedico Rizzoli. Terminated at 1 site in Italy. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2022-04-15.
Sponsored by Istituto Ortopedico Rizzoli · Not applicable, Interventional, and Treatment
This is an interventional study for clinical and radiographic evaluation of patients operated for pseudoarthrosis of the clavicle
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
41 studies on the registry are indexed under Pseudarthrosis; 7 are open to participants now.
This study's enrollment of 20 is close to the median of 22 across 25 interventional studies indexed under Pseudarthrosis.
Browse Pseudarthrosis studies →Istituto Ortopedico Rizzoli is the lead sponsor of 304 studies on the registry; 103 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
range of motion ROM
improvement of range of motion measure (in grade)
Time frame: at least 1 year of follow up
presence of dyskinesias
objective clinical evaluation (elevation, external rotation, abduction) with constant scale (0-25 points)
Time frame: at least 1 year of follow up
alteration of the clavicle length
measure (mm) obtained from radiographic evaluation
Time frame: at least 1 year of follow up
evaluate shoulder function
improvement in Assessment Shoulder and Elbow Scale (ASES) (0-100 points)
Time frame: at least 1 year of follow up
Plan to share: No
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Ran from Jul 2019 to primary completion in Jul 2020, 12 months.
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This study is terminated, as verified in Aug 2021. You cannot join it, but the record below documents what was studied.
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