Clinical Study Relating to Patients Undergoing Medial Femoral Patellar Ligament Reconstruction
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|ClinicalTrials.gov Identifier: NCT04243265|
Recruitment Status : Recruiting
First Posted : January 28, 2020
Last Update Posted : February 5, 2020
|Condition or disease||Intervention/treatment||Phase|
|Patellofemoral Dislocation||Procedure: MPFL reconstruction with fascia lata allograft||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||25 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Clinical Study Relating to Patients Undergoing Medial Femoral Patellar Ligament Reconstruction (MPFL) With Fascia Lata Allograft: 10-year Follow-up.|
|Actual Study Start Date :||December 17, 2015|
|Estimated Primary Completion Date :||December 17, 2025|
|Estimated Study Completion Date :||December 17, 2025|
Experimental: Patients treated with MPFL reconstruction
Patients underwent MPFL reconstruction using a minimally invasive technique using a fascia lata allograft performed at the Rizzoli Orthopedic Institute between 2011 and 2015 by the team of Prof. Marcacci.
Clinical and radiographic evaluation will be performed during outpatients visits.
Procedure: MPFL reconstruction with fascia lata allograft
Reconstruction of MPFL using a fascia lata allograft. The rationale for this technique is to stabilize the patella and limit medium to long-term patellofemoral arthritic degeneration by restoring the MPFL in the most anatomical way possible, not using a tubular graft but an aponeurosis with biomechanical characteristics similar to the native MPFL. The MPFL reconstruction can be used alone or in association with the realignment of the extensor apparatus by transposition of the anterior tibial tuberosity, managing to correct most of the recurrent patellofemoral instabilities. Only in very serious particular cases is it necessary to perform more invasive additional procedures with a more uncertain clinical result (such as Trocleoplasty).
- Visual Analogue Scale [ Time Frame: 120 months ]It is a straight line with one end (score 0) meaning no pain and the other end (score 10) meaning the worst pain imaginable. A patient marks a point on the line that matches the amount of pain he or she feels.
- Short-Form 12 [ Time Frame: 120 months ]
The SF-12 (Short form health survey) is a questionnaire that aims to investigate the perception of individuals' psychophysical conditions. It is taken from a larger version, the SF-36. It is designed to have similar performance to the SF-36, while taking less time to complete.
Two summary scores are reported from the SF-12 - a mental component score (MCS-12) and a physical component score (PCS-12). The scores may be reported as Z-scores (difference compared to the population average, measured in standard deviations). The United States population average PCS-12 and MCS-12 are both 50 points. The United States population standard deviation is 10 points. So each 10 increment of 10 points above or below 50, corresponds to one standard deviation away from the average.
- Kujala knee Score [ Time Frame: 120 months ]The Kujala score is a 13-item questionnaire for the patient-reported assessment of anterior knee pain. Score interval is between 0 (worse result) 100 points (better result)
- Level of Tegner activity [ Time Frame: 120 months ]The Tegner activity scale is a one-item score that graded activity based on work and sports activities on a scale of 0 to 10. Zero represents disability because of knee problems and 10 represents national or international level soccer
- Objective evaluation of the International Knee Documentation Committee [ Time Frame: 120 months ]
The International Knee Documentation Committee (IKDC Questionnaire) is a knee-specific patient-reported outcome which contains sections on knee symptoms (7 items), function (2 items), and sports activities (2 items). It's considered to be one of the most reliable outcome reporting tools in its category and was one of the instruments used in the popular MOON study. IKDC has been subjected to rigorous statistical evaluation and has proven to be a valid and responsive patient-reported outcome measure (PROM).
Scores range from 0 points (lowest level of function or highest level of symptoms) to 100 points (highest level of function and lowest level of symptoms).
- Degree of patello-femoral arthritic degeneration [ Time Frame: 120 months ]
The radiographic evaluation involves the execution of 3 radiographic projections of the operated knee (lateral projection, axial projection of patella at 30° of knee flexion and long-leg standing radiographs.
Radiographs will be evaluated by one independent expert radiologist to determine the degree of patello-femoral arthritic degeneration according to the Iwano radiographic scale.
Stage 0 is normal; stage 1 is mild, in which the joint space is at least 3 mm; stage 2 is moderate, in which the joint space is less than 3 mm, but there is no bony contact; stage 3 is severe, in which partial bony contact less than one-quarter of the joint surface is present; and stage 4 is very severe, in which the joint bony surfaces entirely touch each other.
- Patellar tilt angle [ Time Frame: 120 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, measured on axial projection of patella at 30° of knee flexion.
- Sulcus angle [ Time Frame: 120 months ]Angle formed between lines joining the highest points of the bony medial and lateral condyles and the lowest bony point of the intercondylar sulcus, measured on axial projection of patella at 30° of knee flexion.
- Insall Salvati ratio [ Time Frame: 120 months ]
The Insall-Salvati ratio or index is the ratio of the patella tendon length respect to the length of the patella.
This can be measured on a lateral knee x-ray, with the knee 30 degrees flexed.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04243265
|Contact: Stefano Zaffagnini, MD||+39 051 email@example.com|
|Contact: Giulio Maria Marcheggiani Muccioli, MD, PD||+39 051 firstname.lastname@example.org|
|IRCCS Istituto Ortopedico Rizzoli||Recruiting|
|Bologna, Italy, 40136|
|Contact: Stefano Zaffagnini, MD +39 051 6366075 email@example.com|
|Principal Investigator:||Stefano Zaffagnini, MD, PhD||Istituto Ortopedico Rizzoli|