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

NCT04041258 — Not applicable, Terminated, 20 participants, Istituto Ortopedico Rizzoli

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RegistryNCT04041258, acronym CLAPS
StatusTerminated - the number of patients was not sufficient to support continuation of the study
PhaseNot applicable
Study typeInterventional; na, single group, masking: none, treatment
Enrollment20 (Actual)
SponsorIstituto Ortopedico Rizzoli (Other)
ConditionsPseudoarthrosis of the Clavicle
Interventionspseudoarthrosis of clavicle (Procedure)
Datesstart 2019-07-30, primary completion 2020-07-30, completion 2021-05-01, first posted 2019-08-01, last updated 2022-04-15
Locations1 site in Italy

Related Papers Related Patents Related Grants Related Experts
All trials for Pseudoarthrosis of the Clavicle All trials of pseudoarthrosis of clavicle

-Summary

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

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+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

+Arms and interventions

ArmTypeInterventionsDescription
evaluation of clinical and radiographic findings after surgical treatmentExperimentalProcedure: pseudoarthrosis of clavicleEvaluation of clinical and radiographic findings at least 1 year after surgical treatment for pseudoarthrosis of clavicle
  • pseudoarthrosis of clavicle (Procedure): 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.

+Outcome measures

Primary outcomes

  • 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 outcomes

  • evaluate shoulder function [at least 1 year of follow up]: improvement in Assessment Shoulder and Elbow Scale (ASES) (0-100 points)

+Eligibility

Sex: All, ages: 18 Years to 65 Years

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

+Locations (1)

FacilityCityCountryStatus
Rizzoli Orthopaedic InstituteBolognaItaly