Clinical Study Relating to Patients Undergoing Medial Femoral Patellar Ligament Reconstruction
NCT ID: NCT04243265
Last Updated: 2025-06-04
Study Results
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Basic Information
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COMPLETED
NA
17 participants
INTERVENTIONAL
2015-12-17
2023-08-17
Brief Summary
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Detailed Description
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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 dislocation: patella hypoplasia, genu recurvatum, conditions of ligament hyperlassity, hypoplastic external femoral condyle, trochlear dysplasia, high patella, torsional defects of the lower limb.
The incidence of patella dislocation is estimated to be 5.8 cases per 100,000 people, with values that become five times higher in patients aged between 10 and 17 years. Conservative treatment is preferable in the first case of acute dislocation, however the recurrence of this episode occurs in a percentage equal to 15 - 44% in these subjects.
Many surgical interventions have been described to correct the various factors that predispose to patellofemoral instability, with variable success rates (72% with the Hauser technique and 93% with the Roux-Goldthwait technique, 73% with that of Fielding et at. and 78% with that of Trillat. after a long follow-up.
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 degenerative changes in operated patients compared to patients treated conservatively. This can be explained by the fact that often a single procedure is not sufficient on its own to resolve such a complex pathology, or with the fact that the operations used so far excessively increase the pressures on the patellofemoral cartilage with subsequent arthrosic degeneration.
The medial patello-femoral ligament (MPFL) is one of the main stabilizers of the patella in its movement on the femur; numerous studies have recently shown that this ligament is damaged in almost all cases, thus recognizing the role of structure that most limits the patella in its lateral dislocation to the MPFL (biomechanically speaking about 50 - 60% of the force). Following these studies, the reconstruction of the MPFL as an elective treatment for relapsing patella dislocation has recently been proposed. Currently, countless surgical techniques have been proposed that use various types of grafts: autologous tendons (the first in 1990 from Suganuma et al.), donor tendons (allograft) and synthetic ligaments.
Our team recently developed a minimally invasive MPFL reconstruction technique using an allograft tendon of the fascia lata. The rationale for this technique is to stabilize the patella and limit medium-long term patellofemoral arthritic degeneration by restoring the MPFL in the most anatomical way possible, not using a tubular graft but an aponevrosis with biomechanical characteristics similar to the MPFL native. The MPFL reconstruction can be used alone or in association with the realignment of the extensor system 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 perform additional procedures that are more invasive and have a more uncertain clinical result (such as Trocleoplasty).
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.
Sample is represented by 25 patients underwent MPFL reconstruction using a minimally invasive technique using a donor-sided fascia tendon (allograft) performed at the Rizzoli Orthopedic Institute between 2011 and 2015 by the team of Prof. Marcacci.
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.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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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.
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).
Interventions
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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).
Eligibility Criteria
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Inclusion Criteria
* 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
* 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).
18 Years
ALL
No
Sponsors
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Istituto Ortopedico Rizzoli
OTHER
Responsible Party
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Principal Investigators
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Stefano Zaffagnini, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Istituto Ortopedico Rizzoli
Locations
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IRCCS Istituto Ortopedico Rizzoli
Bologna, , Italy
Countries
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References
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Crosby EB, Insall J. Recurrent dislocation of the patella. Relation of treatment to osteoarthritis. J Bone Joint Surg Am. 1976 Jan;58(1):9-13.
Arnbjornsson A, Egund N, Rydling O, Stockerup R, Ryd L. The natural history of recurrent dislocation of the patella. Long-term results of conservative and operative treatment. J Bone Joint Surg Br. 1992 Jan;74(1):140-2. doi: 10.1302/0301-620X.74B1.1732244.
Chrisman OD, Snook GA, Wilson TC. A long-term prospective study of the Hauser and Roux-Goldthwait procedures for recurrent patellar dislocation. Clin Orthop Relat Res. 1979 Oct;(144):27-30.
Dejour H, Walch G, Neyret P, Adeleine P. [Dysplasia of the femoral trochlea]. Rev Chir Orthop Reparatrice Appar Mot. 1990;76(1):45-54. French.
Desio SM, Burks RT, Bachus KN. Soft tissue restraints to lateral patellar translation in the human knee. Am J Sports Med. 1998 Jan-Feb;26(1):59-65. doi: 10.1177/03635465980260012701.
Fielding JW, Liebler WA, Krishne Urs ND, Wilson SA, Puglisi AS. Tibial tubercle transfer: a long-range follow-up study. Clin Orthop Relat Res. 1979 Oct;(144):43-4.
Hautamaa PV, Fithian DC, Kaufman KR, Daniel DM, Pohlmeyer AM. Medial soft tissue restraints in lateral patellar instability and repair. Clin Orthop Relat Res. 1998 Apr;(349):174-82. doi: 10.1097/00003086-199804000-00021.
Hefti F, Muller W, Jakob RP, Staubli HU. Evaluation of knee ligament injuries with the IKDC form. Knee Surg Sports Traumatol Arthrosc. 1993;1(3-4):226-34. doi: 10.1007/BF01560215.
Iwano T, Kurosawa H, Tokuyama H, Hoshikawa Y. Roentgenographic and clinical findings of patellofemoral osteoarthrosis. With special reference to its relationship to femorotibial osteoarthrosis and etiologic factors. Clin Orthop Relat Res. 1990 Mar;(252):190-7.
Kodraliu G, Mosconi P, Groth N, Carmosino G, Perilli A, Gianicolo EA, Rossi C, Apolone G. Subjective health status assessment: evaluation of the Italian version of the SF-12 Health Survey. Results from the MiOS Project. J Epidemiol Biostat. 2001;6(3):305-16. doi: 10.1080/135952201317080715.
Kujala UM, Jaakkola LH, Koskinen SK, Taimela S, Hurme M, Nelimarkka O. Scoring of patellofemoral disorders. Arthroscopy. 1993;9(2):159-63. doi: 10.1016/s0749-8063(05)80366-4.
Marcacci M, Zaffagnini S, Iacono F, Visani A, Petitto A, Neri NP. Results in the treatment of recurrent dislocation of the patella after 30 years' follow-up. Knee Surg Sports Traumatol Arthrosc. 1995;3(3):163-6. doi: 10.1007/BF01565476.
Monticone M, Ferrante S, Salvaderi S, Rocca B, Totti V, Foti C, Roi GS. Development of the Italian version of the knee injury and osteoarthritis outcome score for patients with knee injuries: cross-cultural adaptation, dimensionality, reliability, and validity. Osteoarthritis Cartilage. 2012 Apr;20(4):330-5. doi: 10.1016/j.joca.2012.01.001. Epub 2012 Jan 10.
Outerbridge RE. The etiology of chondromalacia patellae. 1961. Clin Orthop Relat Res. 2001 Aug;(389):5-8. doi: 10.1097/00003086-200108000-00002. No abstract available.
Smith TO, Walker J, Russell N. Outcomes of medial patellofemoral ligament reconstruction for patellar instability: a systematic review. Knee Surg Sports Traumatol Arthrosc. 2007 Nov;15(11):1301-14. doi: 10.1007/s00167-007-0390-0. Epub 2007 Aug 8.
Suganuma J, Mochizuki R, Shibata R, Sugiki T, Kitamura K, Tani H, Hasegawa M. Reconstruction of the Medial Patellofemoral Ligament With Arthroscopic Control of Patellofemoral Congruence Using Electrical Stimulation of the Quadriceps. Arthrosc Tech. 2016 Jun 20;5(3):e649-56. doi: 10.1016/j.eats.2016.02.022. eCollection 2016 Jun.
Tegner Y, Lysholm J. Rating systems in the evaluation of knee ligament injuries. Clin Orthop Relat Res. 1985 Sep;(198):43-9.
TRILLAT A, DEJOUR H, COUETTE A. [DIAGNOSIS AND TREATMENT OF RECURRENT DISLOCATIONS OF THE PATELLA]. Rev Chir Orthop Reparatrice Appar Mot. 1964 Nov-Dec;50:813-24. No abstract available. French.
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.
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.
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.
Other Identifiers
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MPFL
Identifier Type: -
Identifier Source: org_study_id
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