Back to resultsEVALUATION OF BONE PARAMETERS IN PATIENTS WITH PATELLO-FEMORAL DISORDERS (FeRo-CT)
Primary Purpose
Patello Femoral Syndrome
Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
"Cone Beam Computed Tomography" (CBCT)
Sponsored by
About this trial
This is an interventional diagnostic trial for Patello Femoral Syndrome focused on measuring CT
Eligibility Criteria
Inclusion Criteria:
- Male or female patients, between 18 and 50;
- Pathology or suspected patellofemoral joint pathology in which a CT examination is required for a diagnostic examination;
- Signature of informed consent.
Exclusion Criteria:
- Patients incapable of understanding and will;
- Pregnant women;
- Patients with history of previous fractures of the knee.
- BMI> 40.
Sites / Locations
- Rizzoli Orthopaedic Institute
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Bone patellofemoral joint indices
Arm Description
Evaluation of the bone index values in patients affected by patellofemoral joint disorders, obtained from CT scans performed in both orthostatism and clinostatism
Outcomes
Primary Outcome Measures
Distance between tibial tuberosity and trochlear sulcus
It is a direct measure of the valgus alignment
Secondary Outcome Measures
Full Information
NCT ID
NCT04039776
First Posted
July 30, 2019
Last Updated
July 14, 2022
Sponsor
Istituto Ortopedico Rizzoli
1. Study Identification
Unique Protocol Identification Number
NCT04039776
Brief Title
EVALUATION OF BONE PARAMETERS IN PATIENTS WITH PATELLO-FEMORAL DISORDERS
Acronym
FeRo-CT
Official Title
EVALUATION OF BONE PARAMETERS IN PATIENTS WITH PATELLO-FEMORAL DISORDERS WITH TC IN HORTOSTATISM AND CLINOSTATISM: PILOT STUDY
Study Type
Interventional
2. Study Status
Record Verification Date
July 2022
Overall Recruitment Status
Completed
Study Start Date
February 28, 2020 (Actual)
Primary Completion Date
November 12, 2021 (Actual)
Study Completion Date
November 12, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Istituto Ortopedico Rizzoli
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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
Detailed 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Patello Femoral Syndrome
Keywords
CT
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
25 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Bone patellofemoral joint indices
Arm Type
Experimental
Arm Description
Evaluation of the bone index values in patients affected by patellofemoral joint disorders, obtained from CT scans performed in both orthostatism and clinostatism
Intervention Type
Diagnostic Test
Intervention Name(s)
"Cone Beam Computed Tomography" (CBCT)
Intervention Description
"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.
Primary Outcome Measure Information:
Title
Distance between tibial tuberosity and trochlear sulcus
Description
It is a direct measure of the valgus alignment
Time Frame
1 month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Male or female patients, between 18 and 50;
Pathology or suspected patellofemoral joint pathology in which a CT examination is required for a diagnostic examination;
Signature of informed consent.
Exclusion Criteria:
Patients incapable of understanding and will;
Pregnant women;
Patients with history of previous fractures of the knee.
BMI> 40.
Facility Information:
Facility Name
Rizzoli Orthopaedic Institute
City
Bologna
ZIP/Postal Code
40136
Country
Italy
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
EVALUATION OF BONE PARAMETERS IN PATIENTS WITH PATELLO-FEMORAL DISORDERS
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