Patello Femoral SyndromeFeRo-CTNCT04039776
EVALUATION OF BONE PARAMETERS IN PATIENTS WITH PATELLO-FEMORAL DISORDERS
A study testing "Cone Beam Computed Tomography" (CBCT) in people with Patello Femoral Syndrome, run by Istituto Ortopedico Rizzoli at 1 site in Italy.
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 Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Patello Femoral Syndrome
- What is being tested?
- "Cone Beam Computed Tomography" (CBCT)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteItaly
- Study dates
- 28 Feb 2020to 12 Nov 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- Patients incapable of understanding and will;
- Pregnant women;
- Patients with history of previous fractures of the knee.
- BMI> 40.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: EVALUATION OF BONE PARAMETERS IN PATIENTS WITH PATELLO-FEMORAL DISORDERS WITH TC IN HORTOSTATISM AND CLINOSTATISM: PILOT STUDY
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
Read the 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.
- Conditions
- Patello Femoral Syndrome
- Being tested
- "Cone Beam Computed Tomography" (CBCT)
- Keywords
- CT
- Medical subject headings
- Patellofemoral Pain Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
"Cone Beam Computed Tomography" (CBCT)Diagnostic test
"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.
| Study group | Role | What they receive |
|---|---|---|
| Bone patellofemoral joint indices | Experimental | Evaluation of the bone index values in patients affected by patellofemoral joint disorders, obtained from CT scans performed in both orthostatism and clinostatism Receives: Diagnostic Test: "Cone Beam Computed Tomography" (CBCT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Distance between tibial tuberosity and trochlear sulcus
It is a direct measure of the valgus alignment
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2019
- Study start28 Feb 2020
- Primary completion12 Nov 2021
- Study completion12 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patello Femoral SyndromeStudies of the same condition, open and under way.
- More trials run by Istituto Ortopedico RizzoliThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istituto Ortopedico Rizzoli
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04039776
- Sponsor's protocol ID
- FeRo-CT
- Acronym
- FeRo-CT
- Status last verified
- Jul 2022
- First submitted
- 30 Jul 2019
- Last updated
- 15 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EVALUATION OF BONE PARAMETERS IN PATIENTS WITH PATELLO-FEMORAL DISORDERS WITH TC IN HORTOSTATISM AND CLINOSTATISM: PILOT STUDY
- ClinicalTrials.gov ID
- NCT04039776
- Acronym / sponsor ID
- FeRo-CT / FeRo-CT
- Conditions
- Patello Femoral Syndrome
- Keywords
- CT
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Istituto Ortopedico RizzoliUniversity, hospital or other
- Study start
- 28 Feb 2020 (actual)
- Primary completion
- 12 Nov 2021 (actual)
- Study completion
- 12 Nov 2021 (actual)
- First posted
- 31 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Bone patellofemoral joint indices | Experimental | Diagnostic Test: "Cone Beam Computed Tomography" (CBCT)Evaluation of the bone index values in patients affected by patellofemoral joint disorders, obtained from CT scans performed in both orthostatism and clinostatism |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (4 listed)
- Patients incapable of understanding and will;
- Pregnant women;
- Patients with history of previous fractures of the knee.
- BMI> 40.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| "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. | Diagnostic test | Bone patellofemoral joint indices |
Primary outcome
Distance between tibial tuberosity and trochlear sulcus
Time frame: 1 month
It is a direct measure of the valgus alignment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing "Cone Beam Computed Tomography" (CBCT) in people with Patello Femoral Syndrome, run by Istituto Ortopedico Rizzoli at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Distance between tibial tuberosity and trochlear sulcus (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jul 2022.