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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
Sponsor:
Information provided by (Responsible Party):
Istituto Ortopedico Rizzoli

Brief 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.


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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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




Primary Outcome Measures :
  1. 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°.

  2. 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.

  3. 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.



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Who is able to provide informed consent and who agrees to sign the Informed Consent Form approved by the Ethics Committee (EC).
  • Subject who underwent reconstruction of the MPFL using a minimally invasive technique using a fascia fascia allograft, performed at the Rizzoli Orthopedic Institute between 2012 and 2013 by the team of Prof. Zaffagnini.

Exclusion Criteria:

  • patients with severe morphostructural deformities or other pathologies affecting the knee and lower limb
  • patients with serious systemic vascular and neurological pathologies
  • patients unable to perform a CT scan under weight-bearing
  • State of pregnancy.
  • Obese or with body mass index BMI> 30 kg / m2.
  • Association of Trocleoplasty (intervention that produces degenerative changes of the joint in high percentage)

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): NCT04242732


Contacts
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Contact: Giada Lullini, MD +39 051 6366571 giada.lullini@hotmail.it
Contact: Giulio Maria Marcheggiani Muccioli, MD, PhD +39 051 6366509 marcheggianimuccioli@me.com

Locations
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Italy
IRCCS Istituto Ortopedico Rizzoli Recruiting
Bologna, Italy, 40136
Contact: Giada Lullini, MD    +39 051 6366098    giada.lullini@ior.it   
Sponsors and Collaborators
Istituto Ortopedico Rizzoli
Investigators
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Principal Investigator: Giada Lullini, MD IRCCS Istituto Ortopedico Rizzoli
Publications of Results:

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Responsible Party: Istituto Ortopedico Rizzoli
ClinicalTrials.gov Identifier: NCT04242732    
Other Study ID Numbers: CBCT-MPFL
First Posted: January 27, 2020    Key Record Dates
Last Update Posted: January 27, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Istituto Ortopedico Rizzoli:
Patello femoral dislocation
Medial patello-femoral ligament
Sport trauma
Additional relevant MeSH terms:
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Joint Dislocations
Thinness
Joint Diseases
Musculoskeletal Diseases
Wounds and Injuries
Body Weight
Signs and Symptoms