EVALUATION OF BONE PARAMETERS IN PATIENTS WITH PATELLO-FEMORAL DISORDERS

Patello Femoral Syndrome Clinical Trial

— FeRo-CT  

Official title:

EVALUATION OF BONE PARAMETERS IN PATIENTS WITH PATELLO-FEMORAL DISORDERS WITH TC IN HORTOSTATISM AND CLINOSTATISM: PILOT STUDY

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04039776
• Other study ID #: FeRo-CT
• Status: Completed
• Phase: N/A
• 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
• 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.

Related Conditions & MeSH terms

• Patello Femoral Syndrome
• Patellofemoral Pain Syndrome

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