Clinical Study Relating to Patients Undergoing Medial Femoral Patellar Ligament Reconstruction

NCT04243265 | Completed

• 1 other identifier: MPFL
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

Brief 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 MPFL reconstruction with fascia lata allograft at a minimum follow-up of 2, 5 and 10 years in a group of 25 patients.

Conditions

Patellofemoral Dislocation

Keywords

Patellofemoral Dislocation; MPFL reconstruction

Outcome Measures

Primary Outcomes (5)

• Visual Analogue Scale

  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.

  120 months

• Short-Form 12

  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.

  120 months

• Kujala knee Score

  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)

  120 months

• Level of Tegner activity

  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

  120 months

• Objective evaluation of the International Knee Documentation Committee

  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).

  120 months

Secondary Outcomes (4)

• Degree of patello-femoral arthritic degeneration

  120 months

• Patellar tilt angle

  120 months

• Sulcus angle

  120 months

• Insall Salvati ratio

  120 months

Study Arms (1)

Patients treated with MPFL reconstruction

EXPERIMENTAL

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

Interventions

MPFL reconstruction with fascia lata allograft PROCEDURE

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).

Patients treated with MPFL reconstruction

Eligibility Criteria

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

You may qualify if:

• The potential person is of legal age, capable of providing informed consent and must sign the Informed Consent Form approved by the Ethics Committee (EC).
• Diagnosis of MPFL injury, performed before surgery, documented by Magnetic Resonance Imaging (MRI) of the affected knee.
• Absence of osteochondral lesions larger than 3 cm2 at the baseline.
• The contralateral knee was and is asymptomatic, stable and functional.
• The patient must be physically and mentally inclined and must have completed post-operative rehabilitation according to the protocol provided at the time of discharge.

You may not qualify if:

• Local or systemic infection
• Knee osteoarthritis documented radiographically at baseline
• Articular cartilage injury greater than grade I of Outerbridge detected during surgery.
• History of anaphylactic reaction.
• Systemic therapy with all types of corticosteroids or immunosuppressants in the 30 days prior to surgery.
• Evidence of osteonecrosis in the involved knee.
• History of rheumatoid arthritis, inflammatory arthritis or autoimmune pathologies.
• Neurological pathologies or conditions that the patient is unsuitable for the rehabilitation protocol.
• Untreated meniscal tissue loss greater than 50% at baseline.
• State of pregnancy.
• Obese or with body mass index BMI\> 30 kg / m2.
• Association of Trocleoplasty (intervention that produces degenerative changes in the joint in high apercent).

Sponsors & Collaborators

• Istituto Ortopedico Rizzoli: lead

Study Sites (1)

IRCCS Istituto Ortopedico Rizzoli

Bologna, 40136, Italy

Location

Related Publications (21)

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• Zaffagnini S, Colle F, Lopomo N, Sharma B, Bignozzi S, Dejour D, Marcacci M. The influence of medial patellofemoral ligament on patellofemoral joint kinematics and patellar stability. Knee Surg Sports Traumatol Arthrosc. 2013 Sep;21(9):2164-71. doi: 10.1007/s00167-012-2307-9. Epub 2012 Nov 24.

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• Zaffagnini S, Grassi A, Marcheggiani Muccioli GM, Luetzow WF, Vaccari V, Benzi A, Marcacci M. Medial patellotibial ligament (MPTL) reconstruction for patellar instability. Knee Surg Sports Traumatol Arthrosc. 2014 Oct;22(10):2491-8. doi: 10.1007/s00167-013-2751-1. Epub 2013 Nov 7.

  PMID: 24196574 RESULT

• Zaffagnini S, Marcheggiani Muccioli GM, Grassi A, Bonanzinga T, Marcacci M. Minimally invasive medial patellofemoral ligament reconstruction with fascia lata allograft: surgical technique. Knee Surg Sports Traumatol Arthrosc. 2014 Oct;22(10):2426-30. doi: 10.1007/s00167-014-2940-6. Epub 2014 Mar 22.

  PMID: 24658149 RESULT

Study Officials

• Stefano Zaffagnini, MD, PhD

  Istituto Ortopedico Rizzoli

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 24, 2020
• First Posted: January 28, 2020
• Study Start: December 17, 2015
• Primary Completion: August 17, 2023
• Study Completion: August 17, 2023
• Last Updated: June 4, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)