NCT04039776

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2020

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 30, 2019

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 31, 2019

Completed
7 months until next milestone

Study Start

First participant enrolled

February 28, 2020

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 12, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 12, 2021

Completed
Last Updated

July 15, 2022

Status Verified

July 1, 2022

Enrollment Period

1.7 years

First QC Date

July 30, 2019

Last Update Submit

July 14, 2022

Conditions

Patello Femoral Syndrome

Keywords

CT

Outcome Measures

Primary Outcomes (1)

  • Distance between tibial tuberosity and trochlear sulcus

    It is a direct measure of the valgus alignment

    1 month

Study Arms (1)

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

Diagnostic Test: "Cone Beam Computed Tomography" (CBCT)

Interventions

"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.

Bone patellofemoral joint indices

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • Patients incapable of understanding and will;
  • Pregnant women;
  • Patients with history of previous fractures of the knee.
  • BMI\> 40.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rizzoli Orthopaedic Institute

Bologna, 40136, Italy

Location

MeSH Terms

Conditions

Patellofemoral Pain Syndrome

Interventions

Cone-Beam Computed Tomography

Condition Hierarchy (Ancestors)

Joint DiseasesMusculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Tomography, X-Ray ComputedTomography, X-RayRadiographyDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosisTomography

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 30, 2019

First Posted

July 31, 2019

Study Start

February 28, 2020

Primary Completion

November 12, 2021

Study Completion

November 12, 2021

Last Updated

July 15, 2022

Record last verified: 2022-07

Data Sharing

IPD Sharing
Will not share

Locations

IT(1)