Clinical Study Relating to Patients Undergoing Medial Femoral Patellar Ligament Reconstruction

Patellofemoral Dislocation Clinical Trial

Official title:

Clinical Study Relating to Patients Undergoing Medial Femoral Patellar Ligament Reconstruction (MPFL) With Fascia Lata Allograft: 10-year Follow-up.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04243265
• Other study ID #: MPFL
• Status: Recruiting
• Phase: N/A
• Start date: December 17, 2015
• Est. completion date: December 17, 2025

Study information

• Verified date: May 2024
• Source: Istituto Ortopedico Rizzoli
• Contact: Stefano Zaffagnini, MD
• Phone: +39 051 6366075
• Email: stefano.zaffagnini[@]unibo.it
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Patellofemoral disorders make up about 20% of all knee pathologies and are often a source of diagnostic and therapeutic doubts for the orthopedic surgeon. In fact, the origin of this type of disorder is multifactorial and they can occur in the form of a large variety of clinical pictures with different penetrance in each patient.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 25
• Est. completion date: December 17, 2025
• Est. primary completion date: December 17, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Patellofemoral Dislocation

Intervention

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).

Locations

Country	Name	City	State
Italy	IRCCS Istituto Ortopedico Rizzoli	Bologna

Sponsors (1)

Lead Sponsor	Collaborator
Istituto Ortopedico Rizzoli

Country where clinical trial is conducted

Italy, 

References & Publications (21)

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 — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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):1 — View Citation

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- — View Citation

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. — View Citation

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. — View Citation

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 val — View Citation

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. — View Citation

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. — View Citation

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 J — View Citation

Tegner Y, Lysholm J. Rating systems in the evaluation of knee ligament injuries. Clin Orthop Relat Res. 1985 Sep;(198):43-9. — View Citation

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. — View Citation

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: 10.10 — View Citation

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/s00167-01 — View Citation

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: — View Citation

* Note: There are 21 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	Degree of patello-femoral arthritic degeneration	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.	120 months
Secondary	Patellar tilt angle	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.	120 months
Secondary	Sulcus angle	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.	120 months
Secondary	Insall Salvati ratio	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.	120 months