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Clinical Study Relating to Patients Undergoing Medial Femoral Patellar Ligament Reconstruction

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04243265
Recruitment Status : Recruiting
First Posted : January 28, 2020
Last Update Posted : February 5, 2020
Sponsor:
Information provided by (Responsible Party):
Istituto Ortopedico Rizzoli

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.

Condition or disease Intervention/treatment Phase
Patellofemoral Dislocation Procedure: MPFL reconstruction with fascia lata allograft Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 25 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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).




Primary Outcome Measures :
  1. 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.

  2. 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.


  3. 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)

  4. 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

  5. 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).



Secondary Outcome Measures :
  1. 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.


  2. 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.

  3. 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.

  4. 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.




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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04243265


Contacts
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Contact: Stefano Zaffagnini, MD +39 051 6366075 stefano.zaffagnini@unibo.it
Contact: Giulio Maria Marcheggiani Muccioli, MD, PD +39 051 6366509 marcheggianimuccioli@me.com

Locations
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Italy
IRCCS Istituto Ortopedico Rizzoli Recruiting
Bologna, Italy, 40136
Contact: Stefano Zaffagnini, MD    +39 051 6366075    stefano.zaffagnini@me.com   
Sponsors and Collaborators
Istituto Ortopedico Rizzoli
Investigators
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Principal Investigator: Stefano Zaffagnini, MD, PhD Istituto Ortopedico Rizzoli
Publications of Results:

Other Publications:
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Responsible Party: Istituto Ortopedico Rizzoli
ClinicalTrials.gov Identifier: NCT04243265    
Other Study ID Numbers: MPFL
First Posted: January 28, 2020    Key Record Dates
Last Update Posted: February 5, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Istituto Ortopedico Rizzoli:
Patellofemoral Dislocation
MPFL reconstruction
Additional relevant MeSH terms:
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Joint Dislocations
Joint Diseases
Musculoskeletal Diseases
Wounds and Injuries