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Patellar Stability After MPFL Reconstruction With Fascia Lata Allograft: Conventional CT vs Under Weight-bearing CT

Primary Purpose

Patellofemoral Dislocation

Status
Active
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
CT scan of the knee under weight-bearing with the Cone Beam Computed Tomography (CBCT) scanner system.
Conventional CT scan
Sponsored by
Istituto Ortopedico Rizzoli
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Patellofemoral Dislocation focused on measuring Patello femoral dislocation, Medial patello-femoral ligament, Sport trauma

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Who is able to provide informed consent and who agrees to sign the Informed Consent Form approved by the Ethics Committee (EC).
  • Subject who underwent reconstruction of the MPFL using a minimally invasive technique using a fascia fascia allograft, performed at the Rizzoli Orthopedic Institute between 2012 and 2013 by the team of Prof. Zaffagnini.

Exclusion Criteria:

  • patients with severe morphostructural deformities or other pathologies affecting the knee and lower limb
  • patients with serious systemic vascular and neurological pathologies
  • patients unable to perform a CT scan under weight-bearing
  • State of pregnancy.
  • Obese or with body mass index BMI> 30 kg / m2.
  • Association of Trocleoplasty (intervention that produces degenerative changes of the joint in high percentage)

Sites / Locations

  • IRCCS Istituto Ortopedico Rizzoli

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

MPFL reconstructed

Arm Description

20 patients with previous recurrent patella dislocation who underwent MPFL reconstruction surgery with fascia lata allograft between 2012 and 2013

Outcomes

Primary Outcome Measures

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 plane on the axial plane, measured both by conventional CT scan with the knee extended and by CT scan under weight bearing conditions with the knee flexed at 30°.
Patellar Congruence Angle
Angle made by a line parallel to the posterior condyles and the line joining the edges of the patella on the axial plane, measured under weight-bearing with knee flexed at 30° and supine with knee extended.
Tibial tuberosity-trochlear groove distance
Radiographic parameter measured by CT scan both under weight-bearing with knee flexed at 30° and supine with knee extended.

Secondary Outcome Measures

Full Information

First Posted
January 20, 2020
Last Updated
May 29, 2023
Sponsor
Istituto Ortopedico Rizzoli
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1. Study Identification

Unique Protocol Identification Number
NCT04242732
Brief Title
Patellar Stability After MPFL Reconstruction With Fascia Lata Allograft: Conventional CT vs Under Weight-bearing CT
Official Title
Assessment of Patellar Stability in Patients Who Underwent Reconstruction of the Medium Patello-femoral Ligament With Fascia Lata Allograft: Comparison Between Conventional CT and Under Weight-bearing CT
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
February 26, 2019 (Actual)
Primary Completion Date
May 26, 2023 (Actual)
Study Completion Date
February 26, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Istituto Ortopedico Rizzoli

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The objective of the present study is to compare the stability and alignment of the patella in patients with previous recurrent dislocation treated with medial patellar femoral ligament reconstruction with fascia lata allograft, 5 years after surgery by conventional CT and by CT under weight-bearing. Conventional CT will be performed with the patient supine, the knee fully extended and with the muscles of the thigh and leg completely relaxed. On the same day, the patient will undergo a CT scan of the knee under weight-bearing with the Cone Beam Computed Tomography (CBCT) scanner system. The CT images will be viewed through the PACS system by two independently expert radiologists who will measure the tilt, congruence angles and the TT-TG with the methodical notes described in the literature. The use of a CT under weight-bearing allows for the first time to evaluate in a realistic way the stability and tracking of the patella, with the knee flexed and therefore with the activation of the quadriceps muscle.
Detailed 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. 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 and 78% with that of Trillat after a long follow-up. 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 the structure that most limits the patella in its lateral dislocation to the MPFL. Following these studies, the reconstruction of the MPFL as an elective treatment for relapsing patella dislocation has been recently proposed with countless surgical techniques that use various types of grafts: autologous tendons (the first in 1990 by Suganuma et al), tendons from donor (allograft) and synthetic ligaments. Our team recently developed a minimally invasive MPFL reconstruction technique using an allograft tendon of the fascia lata with the aim of stabilizing the patella and limiting the patellofemoral arthritic degeneration in the medium to long term. The imaging evaluation of instability and correct alignment of the patella, both in the pre-operative and in the post-surgery, is normally performed using magnetic resonance imaging or conventional CT. The CT offers the advantage of being able to make a very accurate morphological evaluation and therefore to be able to calculate with great precision the degrees of the tilt angle of the patella, the subluxation and the distance between the tibial tuberosity and the center of the trochlear sulcus (TT-TG ). The big limit of this method is that the patient is acquired supine, with the knee extended and with the muscles of the leg relaxed while it is well known how the knee flexion and the contraction of the quadriceps muscle possible in load, significantly affect the tracking of the patella on the trochlea. In literature, numerous studies show that the acquisition of the lying patient removes these determining factors (Callaghan; Draper; Tanaka) by altering the assessment of instability and malalignment. In a recent study by Marzo et al. it has been shown that in subjects suffering from instability of the patella, the evaluation under weight-bearing and with knee flexed by CT (CBCT Carestream) shows lower tilt angles, congruence and TT-TG than the evaluation in load and therefore the evaluation under load of the patellar alignment is more adequate to evaluate with precision these parameters. The objective of the present study is to compare the stability and alignment of the patella in patients with previous relapsing dislocation treated with reconstruction surgery by means of a medial patellar ligament with lata band allograft 5 years after surgery by conventional CT and by CT under weight-bearing. The assessments are carried out in a group of 20 patients with previous recurrent patella dislocation who underwent reconstruction surgery between 2012 and 2013 via a medial patello-femoral ligament with fascia lata allograft at the Orthopedic and Traumatologic Clinic 2nd of the Rizzoli Orthopedic Institute. The patients will be contacted by phone and a follow-up visit will be scheduled which is normally carried out 5 years after the operation to evaluate the stability of the patella and therefore the patient's clinical condition. The patient will undergo a clinical examination and radiological control with conventional CT at the Rizzoli Orthopedic Institute. Conventional CT will be performed with the patient supine, the knee fully extended and with the muscles of the thigh and leg completely relaxed. On the same day, the patient will undergo a CT scan of the knee under weight-bearing with the Cone Beam Computed Tomography (CBCT) scanner system.The CT images will be viewed through the PACS system by two independently expert radiologists who will measure the tilt, congruence angles and the TT-TG with the methodical notes described in the literature. The use of a CT under weight-bearing allows for the first time to evaluate in a realistic way the stability and tracking of the patella, with the knee flexed and therefore with the activation of the quadriceps muscle.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Patellofemoral Dislocation
Keywords
Patello femoral dislocation, Medial patello-femoral ligament, Sport trauma

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
MPFL reconstructed
Arm Type
Experimental
Arm Description
20 patients with previous recurrent patella dislocation who underwent MPFL reconstruction surgery with fascia lata allograft between 2012 and 2013
Intervention Type
Diagnostic Test
Intervention Name(s)
CT scan of the knee under weight-bearing with the Cone Beam Computed Tomography (CBCT) scanner system.
Intervention Description
The patient will be evaluated under weight-bearing, with knee flexed at 30 ° and therefore with contracted thigh muscles. The measurement and maintenance of the 30 ° of flexion will be controlled by a goniometer applied laterally to the knee and fixed by means of an elastic band.
Intervention Type
Diagnostic Test
Intervention Name(s)
Conventional CT scan
Intervention Description
The patient will be evaluated in supine position, with the muscles relaxed and the knee in full extension by conventional CT scan
Primary Outcome Measure Information:
Title
Patellar Tilt Angle
Description
The tilt angle is defined as the angle subtended by a line joining the medial and lateral edges of the patella and the horizontal plane on the axial plane, measured both by conventional CT scan with the knee extended and by CT scan under weight bearing conditions with the knee flexed at 30°.
Time Frame
24 months
Title
Patellar Congruence Angle
Description
Angle made by a line parallel to the posterior condyles and the line joining the edges of the patella on the axial plane, measured under weight-bearing with knee flexed at 30° and supine with knee extended.
Time Frame
24 months
Title
Tibial tuberosity-trochlear groove distance
Description
Radiographic parameter measured by CT scan both under weight-bearing with knee flexed at 30° and supine with knee extended.
Time Frame
24 months

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Who is able to provide informed consent and who agrees to sign the Informed Consent Form approved by the Ethics Committee (EC). Subject who underwent reconstruction of the MPFL using a minimally invasive technique using a fascia fascia allograft, performed at the Rizzoli Orthopedic Institute between 2012 and 2013 by the team of Prof. Zaffagnini. Exclusion Criteria: patients with severe morphostructural deformities or other pathologies affecting the knee and lower limb patients with serious systemic vascular and neurological pathologies patients unable to perform a CT scan under weight-bearing State of pregnancy. Obese or with body mass index BMI> 30 kg / m2. Association of Trocleoplasty (intervention that produces degenerative changes of the joint in high percentage)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Giada Lullini, MD
Organizational Affiliation
IRCCS Istituto Ortopedico Rizzoli
Official's Role
Principal Investigator
Facility Information:
Facility Name
IRCCS Istituto Ortopedico Rizzoli
City
Bologna
ZIP/Postal Code
40136
Country
Italy

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
1732244
Citation
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.
Results Reference
result
PubMed Identifier
535237
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.
Results Reference
result
PubMed Identifier
1249117
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.
Results Reference
result
PubMed Identifier
2140459
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.
Results Reference
result
PubMed Identifier
9474403
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.
Results Reference
result
PubMed Identifier
535248
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.
Results Reference
result
PubMed Identifier
9584380
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.
Results Reference
result
PubMed Identifier
8536037
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.
Results Reference
result
PubMed Identifier
2302884
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):190-7.
Results Reference
result
PubMed Identifier
11437095
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):305-16. doi: 10.1080/135952201317080715.
Results Reference
result
PubMed Identifier
8461073
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.
Results Reference
result
PubMed Identifier
24196574
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/s00167-013-2751-1. Epub 2013 Nov 7.
Results Reference
result
PubMed Identifier
8821272
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.
Results Reference
result
PubMed Identifier
22285738
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 validity. Osteoarthritis Cartilage. 2012 Apr;20(4):330-5. doi: 10.1016/j.joca.2012.01.001. Epub 2012 Jan 10.
Results Reference
result
PubMed Identifier
11501822
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.
Results Reference
result
PubMed Identifier
17684729
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.
Results Reference
result
PubMed Identifier
4028566
Citation
Tegner Y, Lysholm J. Rating systems in the evaluation of knee ligament injuries. Clin Orthop Relat Res. 1985 Sep;(198):43-9.
Results Reference
result
PubMed Identifier
14256559
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.
Results Reference
result
PubMed Identifier
23179455
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: 10.1007/s00167-012-2307-9. Epub 2012 Nov 24.
Results Reference
result
PubMed Identifier
24658149
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: 10.1007/s00167-014-2940-6. Epub 2014 Mar 22.
Results Reference
result
PubMed Identifier
28050572
Citation
Marzo J, Kluczynski M, Notino A, Bisson L. Comparison of a Novel Weightbearing Cone Beam Computed Tomography Scanner Versus a Conventional Computed Tomography Scanner for Measuring Patellar Instability. Orthop J Sports Med. 2016 Dec 7;4(12):2325967116673560. doi: 10.1177/2325967116673560. eCollection 2016 Dec.
Results Reference
result

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Patellar Stability After MPFL Reconstruction With Fascia Lata Allograft: Conventional CT vs Under Weight-bearing CT

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