Patellar Stability After MPFL Reconstruction With Fascia Lata Allograft: Conventional CT vs Under… (NCT04242732) | Clinical Trial Compass
CompletedNot Applicable
Patellar Stability After MPFL Reconstruction With Fascia Lata Allograft: Conventional CT vs Under Weight-bearing CT
Italy20 participantsStarted 2019-02-26
Plain-language 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.
Who can participate
Sex
ALL
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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)
Questions worth asking your doctor
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1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
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Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.