CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 20 enrolled
Drug / intervention
CT scan of the knee under weight-bearing with the Cone Beam Computed Tomography (CBCT) scanner system. +1 moreother
Likely dose
Not stated in record
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Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04242732
NCT04242732N/ACompleted
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Assessment of Patellar Stability in Patients Who Underwent Reconstruction of the Medium Patello-femoral Ligament With Fascia Lata Allograft: Comparison Between Conventional CT and Under Weight-bearing CT

Istituto Ortopedico Rizzoli·interventional·Posted Jan 27, 2020·Updated May 29, 2024

In Brief

A clinical study evaluating CT scan of the knee under weight-bearing with the Cone Beam Computed Tomography (CBCT) scanner system. and Conventional CT scan for Patellofemoral Dislocation. Completed, enrolled 20 participants across 1 site.

Detailed Summary

The objective of the present study is to compare the stability and alignment of the patella in patients with previous recurrent dislocation treated with medial patellar femoral ligament reconstruction with fascia lata allograft, 5 years after surgery by conventional CT and by CT under weight-bearing. Conventional CT will be performed with the patient supine, the knee fully extended and with the muscles of the thigh and leg completely relaxed. On the same day, the patient will undergo a CT scan of the knee under weight-bearing with the Cone Beam Computed Tomography (CBCT) scanner system. The CT images will be viewed through the PACS system by two independently expert radiologists who will measure the tilt, congruence angles and the TT-TG with the methodical notes described in the literature. The use of a CT under weight-bearing allows for the first time to evaluate in a realistic way the stability and tracking of the patella, with the knee flexed and therefore with the activation of the quadriceps muscle.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPatellofemoral Dislocation
CountriesItaly
Collaborators--

Timeline

N/ACompletedFinished
20192020202120222023202420252026
First PostedJan 27, 2020
Enrollment StartFeb 26, 2019
Primary CompletionMay 26, 2019
Study CompletionFeb 26, 2020
TodayJul 2, 2026
Enrollment to primary: 3 monthsPosted 6.4 years ago

Interventions

CT scan of the knee under weight-bearing with the Cone Beam Computed Tomography (CBCT) scanner system.other

The patient will be evaluated under weight-bearing, with knee flexed at 30 ° and therefore with contracted thigh muscles. The measurement and maintenance of the 30 ° of flexion will be controlled by a goniometer applied laterally to the knee and fixed by means of an elastic band.

Conventional CT scanother

The patient will be evaluated in supine position, with the muscles relaxed and the knee in full extension by conventional CT scan