Patellar Stability After MPFL Reconstruction With Fascia Lata Allograft: Conventional CT vs Under Weight-bearing CT

NCT04242732 | Completed

• 1 other identifier: CBCT-MPFL
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Patellofemoral Dislocation

Keywords

Patello femoral dislocation; Medial patello-femoral ligament; Sport trauma

Outcome Measures

Primary Outcomes (3)

• Patellar Tilt Angle

  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°.

  24 months

• Patellar Congruence Angle

  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.

  24 months

• Tibial tuberosity-trochlear groove distance

  Radiographic parameter measured by CT scan both under weight-bearing with knee flexed at 30° and supine with knee extended.

  24 months

Study Arms (1)

MPFL reconstructed

EXPERIMENTAL

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.; Diagnostic Test: Conventional CT scan

Interventions

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

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.

MPFL reconstructed

Conventional CT scan DIAGNOSTIC_TEST

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

MPFL reconstructed

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Istituto Ortopedico Rizzoli: lead

Study Sites (1)

IRCCS Istituto Ortopedico Rizzoli

Bologna, 40136, Italy

Location

Related Publications (21)

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• Marzo J, Kluczynski M, Notino A, Bisson L. Comparison of a Novel Weightbearing Cone Beam Computed Tomography Scanner Versus a Conventional Computed Tomography Scanner for Measuring Patellar Instability. Orthop J Sports Med. 2016 Dec 7;4(12):2325967116673560. doi: 10.1177/2325967116673560. eCollection 2016 Dec.

  PMID: 28050572 RESULT

Study Officials

• Giada Lullini, MD

  IRCCS Istituto Ortopedico Rizzoli

  PRINCIPAL INVESTIGATOR

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: January 20, 2020
• First Posted: January 27, 2020
• Study Start: February 26, 2019
• Primary Completion: May 26, 2019
• Study Completion: February 26, 2020
• Last Updated: May 29, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)