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

Status

Terminated

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04041258

Acronym

CLAPS

Enrollment

Registered

2019-08-01

Start date

2019-07-30

Completion date

2021-05-01

Last updated

2022-04-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pseudoarthrosis of the Clavicle

Keywords

pseudoarthrosis, clavicle

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

Interventions

PROCEDUREpseudoarthrosis 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.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Intervention model description

interventional study

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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

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

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026