Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

EVALUATION OF BONE PARAMETERS IN PATIENTS WITH PATELLO-FEMORAL DISORDERS (FeRo-CT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04039776
Recruitment Status : Recruiting
First Posted : July 31, 2019
Last Update Posted : August 2, 2019
Sponsor:
Information provided by (Responsible Party):
Federica Balboni, Istituto Ortopedico Rizzoli

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 ortostatism and clinostatism

Condition or disease Intervention/treatment Phase
Patello Femoral Syndrome Diagnostic Test: "Cone Beam Computed Tomography" (CBCT) Not Applicable

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 ortostatism 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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 25 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: EVALUATION OF BONE PARAMETERS IN PATIENTS WITH PATELLO-FEMORAL DISORDERS WITH TC IN HORTOSTATISM AND CLINOSTATISM: PILOT STUDY
Actual Study Start Date : July 30, 2019
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : December 31, 2019

Intervention Details:
  • 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.


Primary Outcome Measures :
  1. Distance between tibial tuberosity and trochlear sulcus [ Time Frame: 1 month ]
    It is a direct measure of the valgus alignment



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04039776


Contacts
Layout table for location contacts
Contact: Alessandro Di Martino 0516366514 a.dimartino@biomec.ior.it
Contact: Alice Roffi 0516336072 alice.roffi@ior.it

Locations
Layout table for location information
Italy
Rizzoli Orthopaedic Institute Recruiting
Bologna, Italy, 40136
Contact: Alessandro Di Martino, MD    0516366514    alessandro.dimartino@ior.it   
Contact: Alice Roffi    0516366072    alice.roffi@ior.it   
Sponsors and Collaborators
Istituto Ortopedico Rizzoli
Layout table for additonal information
Responsible Party: Federica Balboni, Sub-Investigator, Istituto Ortopedico Rizzoli
ClinicalTrials.gov Identifier: NCT04039776    
Other Study ID Numbers: FeRo-CT
First Posted: July 31, 2019    Key Record Dates
Last Update Posted: August 2, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Federica Balboni, Istituto Ortopedico Rizzoli:
CT
Additional relevant MeSH terms:
Layout table for MeSH terms
Patellofemoral Pain Syndrome
Joint Diseases
Musculoskeletal Diseases