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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04039776
Other study ID # FeRo-CT
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date February 28, 2020
Est. completion date November 12, 2021

Study information

Verified date July 2022
Source Istituto Ortopedico Rizzoli
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The aim of the study is to compare, in patients with patellofemoral joint disorders, the values related to the bone indexes of this joint, obtained from CT performed both in orthostatism and clinostatism


Description:

The aim of the study is to compare, in patients with patellofemoral joint disorders, the values related to the bone indexes of this joint, obtained from CT performed both in orthostatism and clinostatism. Young patients with patellofemoral joint pathology, for which a diagnostic examination is necessary in order to determine a possible surgical indication, will be included in this pilot study, and will be evaluated using the "Cone Beam Computed Tomography "(CBCT), a machine that use a low dose of radiation compared to traditional CT systems, and allows the examination in supine and standing position knee . In this way, for the same patient it will be possible to calculate the bone indexes both in weight-bearing condition and in non-weight-bearing, comparing the values between them, to identify possible differences due to the influence of orthostatism.


Recruitment information / eligibility

Status Completed
Enrollment 25
Est. completion date November 12, 2021
Est. primary completion date November 12, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years to 50 Years
Eligibility Inclusion Criteria: 1. Male or female patients, between 18 and 50; 2. Pathology or suspected patellofemoral joint pathology in which a CT examination is required for a diagnostic examination; 3. Signature of informed consent. Exclusion Criteria: 1. Patients incapable of understanding and will; 2. Pregnant women; 3. Patients with history of previous fractures of the knee. 4. BMI> 40.

Study Design


Related Conditions & MeSH terms


Intervention

Diagnostic Test:
"Cone Beam Computed Tomography" (CBCT)
"Cone Beam Computed Tomography "(CBCT), a machine that use a low dose of radiation compared to traditional CT systems, and allows the examination in supine and standing position knee . In this way, for the same patient it will be possible to calculate the bone indexes both in weight-bearing condition and in non-weight-bearing, comparing the values between them, to identify possible differences due to the influence of orthostatism.

Locations

Country Name City State
Italy Rizzoli Orthopaedic Institute Bologna

Sponsors (1)

Lead Sponsor Collaborator
Istituto Ortopedico Rizzoli

Country where clinical trial is conducted

Italy, 

Outcome

Type Measure Description Time frame Safety issue
Primary Distance between tibial tuberosity and trochlear sulcus It is a direct measure of the valgus alignment 1 month
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