Patellar Stability After MPFL Reconstruction With Fascia Lata Allograft: Conventional CT vs Under Weight-bearing CT
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|ClinicalTrials.gov Identifier: NCT04242732|
Recruitment Status : Recruiting
First Posted : January 27, 2020
Last Update Posted : January 27, 2020
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.
|Condition or disease||Intervention/treatment||Phase|
|Patellofemoral Dislocation||Diagnostic Test: CT scan of the knee under weight-bearing with the Cone Beam Computed Tomography (CBCT) scanner system. Diagnostic Test: Conventional CT scan||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||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|
|Actual Study Start Date :||February 26, 2019|
|Estimated Primary Completion Date :||February 26, 2021|
|Estimated Study Completion Date :||February 26, 2021|
Experimental: MPFL reconstructed
20 patients with previous recurrent patella dislocation who underwent MPFL reconstruction surgery with fascia lata allograft between 2012 and 2013
Diagnostic Test: CT scan of the knee under weight-bearing with the Cone Beam Computed Tomography (CBCT) scanner system.
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.
Diagnostic Test: Conventional CT scan
The patient will be evaluated in supine position, with the muscles relaxed and the knee in full extension by conventional CT scan
- Patellar Tilt Angle [ Time Frame: 24 months ]The tilt angle is defined as the angle subtended by a line joining the medial and lateral edges of the patella and the horizontal plane on the axial plane, measured both by conventional CT scan with the knee extended and by CT scan under weight bearing conditions with the knee flexed at 30°.
- Patellar Congruence Angle [ Time Frame: 24 months ]Angle made by a line parallel to the posterior condyles and the line joining the edges of the patella on the axial plane, measured under weight-bearing with knee flexed at 30° and supine with knee extended.
- Tibial tuberosity-trochlear groove distance [ Time Frame: 24 months ]Radiographic parameter measured by CT scan both under weight-bearing with knee flexed at 30° and supine with knee extended.
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): NCT04242732
|Contact: Giada Lullini, MD||+39 051 firstname.lastname@example.org|
|Contact: Giulio Maria Marcheggiani Muccioli, MD, PhD||+39 051 email@example.com|
|IRCCS Istituto Ortopedico Rizzoli||Recruiting|
|Bologna, Italy, 40136|
|Contact: Giada Lullini, MD +39 051 6366098 firstname.lastname@example.org|
|Principal Investigator:||Giada Lullini, MD||IRCCS Istituto Ortopedico Rizzoli|