Clinical Study Relating to Patients Undergoing Medial Femoral Patellar Ligament Reconstruction
-
- STATUS
- Recruiting
-
- End date
- Dec 17, 2025
-
- participants needed
- 25
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- sponsor
- Istituto Ortopedico Rizzoli
Summary
The objective of the present study will be to evaluate the clinical patellofemoral joint
function (primary endpoint) and radiographically the patellofemoral arthritic degeneration
(secondary endpoint) of of
Description
In accordance with the classification of Dejour et al., the instability of the patella can be
divided into traumatic and a-traumatic (recurrent or habitual). The latter patients may
present a variety of anatomical anomalies that predispose to
The incidence of
Many
On the other hand, Crosby and Insall, Arnbjornsson et al. and Marcacci et al. have
demonstrated a similar clinical outcome in long-term controlled studies but an increase in
The medial patello-femoral ligament (
Our team recently developed a minimally invasive
The objective of the present study will be to evaluate the clinical patellofemoral joint
function (primary endpoint) and radiographically the patellofemoral arthritic degeneration
(secondary endpoint) of of
Sample is represented by 25 patients underwent
Any concomitant treatments: treatment of associated meniscal lesions (meniscectomy), reconstruction of the anterior cruciate ligament (ACL), realignment of the extensor system by transposition of the anterior tibial tuberosity (intervention by Elmsile-Trillat).
Follow-up visit will be carried out at 2, 5 and 10 years of average follow-up. The "non parametric Wilcoxon" and "paired Student's t-test" tests will be used to determine the changes between the various follow-up intervals in the outcome measurements respectively for the non-parametric variables (Tegner activity level) and for the parametric ones ( SF-12 test, VAS pain test, KOOS test, Kujala test, "tilt" and "sulcus" angles, "Insall-Salvati" report).
The changes between the various follow-up intervals in the objective IKDC score and in the Iwano score will be assessed by means of the "Pearson chi-square test".
All "p values" will be 2-tailed; the significance level will be defined at p 0.05.
Details
Condition |
Patellofemoral |
---|---|
Age | 18years - 100years |
Treatment |
|
Clinical Study Identifier | NCT04243265 |
Sponsor | Istituto Ortopedico Rizzoli |
Last Modified on | 19 February 2024 |
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.
Learn moreIf you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.
Learn moreComplete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.
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