VALIDATION OF METHODSAND PROCESSES -USFDA India Seminar 2011 at Mumbai
100 cases - follow-up > 10 years · 100 cases - follow-up > 10 years. MaterielMateriel and...
Transcript of 100 cases - follow-up > 10 years · 100 cases - follow-up > 10 years. MaterielMateriel and...
ResultsResults of ACL reconstruction for of ACL reconstruction for chronicchronic kneeknee instabilityinstability, , usingusing one one thirdthird of the of the patellarpatellar tendon tendon augmentedaugmented by by extraextra--
articulararticular plastyplasty" Mac " Mac InJonesInJones" " operationoperation
100 cases 100 cases -- followfollow--upup > 10 > 10 yearsyears
Materiel and methodsMaterielMateriel andand methodsmethods
Prospective study1OO knees from 134 consecutive operations
(1 surgeon, 1 technique)
• Chronic cases• Accident to surgery interval : 4 ± 4.8 ys• Mean age : 27.8 ± 9 years• Males : 58 %• Sport’s trauma : 83 %• Previous surgery in 32 cases :
15 ACL reconstructions,Meniscal resections : 18 med, 5 lat
• Follow-up : 11.7 ± 2 ys (10 to 16)
"Mac InJones » procedure
• Patellar tendon (10 mm)• Quadricipital tendon : 12 cm• Trapezoïdal shaped patellar bone
• Special femoral visor• Diameter : 9 mm • bone is recuperated
((Derived from bothDerived from both MacIntosh MacIntosh and and Jones Jones proceduresprocedures))
Free Free graftgraft
Introduction from outside to inside through the condyle
Stability of the trapezoïdal patellar block into the tunnel by pushing with a hammer
Fixation in the tibia with ametallic wire and a screw
Progressive tension untilsuppression of the drawer
Bony fragments into the tibial tunnel
Sometimes 1 additional interference screw
"Mac InJones » procedure
1rst step : ACL reconstruction
2d 2d stepstep : : LateralLateral extraextra--articulararticular plastyplasty
QuadricipitalQuadricipital tendon tendon isis stretchedstretched fromfrom the condyle the condyle to the Gerdyto the Gerdy’’s tubercule s tubercule withwith solidsolid suturessutures
"Mac InJones » procedure
"Mac InJones » procedure
With this procedure and the tension adjusted by torsion of
a metallic wire on a screwJL Lerat (1979)
It had become clear than thegraft was sufficiently solidly
fixed at both its ends to authorize
immediate mobilisationin full flexion and extensionand agressive rehabilitation
program JL Lerat (1979)
1rst case 19791rst case 1979
QuadricipitalQuadricipital tendon tendon isis stretchedstretched fromfrom the condyle the condyle to the Gerdyto the Gerdy’’s tubercule s tubercule withwith solidsolid sutures sutures
Fragments of Fragments of bone fillbone fillthe the patellar patellar trenchtrench
Mean Mean skin incision : 13 cm skin incision : 13 cm ±± 33
MaterielMaterielMateriel
100 knees evaluated
• 88 examinated and radiographied• + 12 questionnaires
17 patients lost for follow-up
+ 3 patients died
AnatomicalAnatomical valuevalue
-- KTKT--1000 1000 arthrometerarthrometer-- AnteriorAnterior radiologicalradiological
drawerdrawer
FunctionFunction
-- IKDCIKDC (International (International KneeKneeDocumentation Documentation CommiteeCommitee))
-- A.R.P.E.GE scoreA.R.P.E.GE score
MethodsMethodsMethods
MethodsMethods
KT-1000 Arthrometer(preop - post-op)
• KT 1 : 69 n• KT 2 : 89 n• KT 3 : maxi-manual
Stress radiography(preop - post-op)
• 20° of flexion• Load : 9 kg• Translation of medial and
lateral compartments
Per-operative findings
• Medial meniscus lesions : 30 %+ 25 previous meniscectomies = 55 %
• Lateral meniscus lesions : 19 %
• Cartilages lesions : 19 %– Medial : 12– Lateral : 4– Both : 3
Complications
• 7 ematomas• 2 DVT• 1 temporary peroneal nerve palsy• 2 SND• 3 skin infections • 1 infection
Results Results Results
• Flexion : 143° ± 11• Flexion contracture : 4.5° ± 7• Amyotrophy : 1 cm ± 0.8 (28 having none)
• Recurrence of laxity : 9 cases• Pivot-shift test
++ : 3 %+ : 22 %
0
10
20
30
40
50
60
Pain effusion apprehension
Activity +++activity ++activity +sedentary
SymptomsSymptoms according according toto activity level activity level
Functional resultsFunctional results
05
101520253035404550
Excellent- A
Good - B Poor - C Bad - D
ARPEGE scoreIKDC
A.R.P.E.GE : 60 % excellent + good
IKDC score : 61 % excellent + good
0 10 20 30 40 50
sports
No sportotherVolleyTennisSkirugbyfightMountainBasketFootballRunningBasket
CompetitionCompetition : 58: 58
Recreative Recreative : 35: 35
Sport Sport before before traumatrauma
0
10
20
30
40
50
60
pivot-contact
pivot Withoutpivot
Nosport
Before trauma
preop
follow-up
Sport Sport activityactivity• Satisfaction expressed by the patients : 88 %• 78 % of the patients return to sport activities• Sport with pivot : 30 % (competition : 17 %) • 14 patients stop sport for other reasons
0
10
20
30
40
50
60
70
competition recreative active sedentary
before traumapreopfollow-up
EvolutionEvolution of sport of sport activity levelactivity level
02468
10121416
preop G.A preop G.A post-op
6 m 10 years
KT 1KT 2KT3
ArthrometricArthrometric evolutionevolution
KT-1000 Arthrometer KT 1 : 69 nKT 2 : 89 nKT 3 : maxi-manual
« Knee instability after injury to the anterior cruciate ligament
Quantification of the Lachman test »
JL Lerat, B Moyen, F Cladière, JL Besse, H Abidi
J. Bone Joint Surgery VOL. 82-B, N°1, January 2000, 42-47.
Radiological anterior drawerRadiological anterior drawer
AnteriorAnterior radiologicalradiological drawerdrawer
ATMC: ATMC: Anterior Anterior Translation of Translation of Medial CompartmentMedial Compartment
ATLC : ATLC : Anterior Anterior Translation of Translation of Lateral CompartmentLateral Compartment
•• Flexion : 20Flexion : 20°°•• Load Load : 9 kg : 9 kg •• Free rotationFree rotation•• ComfortableComfortable for the for the
patientpatient•• Simple Simple apparatusapparatus
PathologicalPathological ATMCATMC andand ATLCATLC
AnteriorAnterior radiologicalradiological drawerdrawer
Differential laxity
PathologicalPathological ATMCATMC and and ATLC ATLC Normal Normal contralateral kneecontralateral knee
Precice and objective measurement of preop and post-op laxity
PathologicalPathological ATMCATMC and and ATLC ATLC Post Post op op 10 10 yearsyears
ACL ACL deficient kneesdeficient knees : : differential antdifferential ant. translation. translation
ATLC7.3 ± 4 mm
ATMC
7.8 ± 4.2 mm
0
10
20
30
40
50
60
70
80
-5 0 5 10 15 20 25
Differential ATLC
0
10
20
30
40
50
60
70
80
-5 0 5 10 15 20
Differential ATMC
Evolution of Evolution of radiologicalradiological laxitylaxity
0123456789
preop 6 m 1 year > 10 y
ATMCATLC
Gain for ATMC : 62 % Gain for ATMC : 62 % Gain for ATLC : 77 %Gain for ATLC : 77 %
Differential sideDifferential side to to side laxityside laxity
AB/AC x 100AB/AC x 100 AT/AC x 100AT/AC x 100 IT/IE x 100IT/IE x 100
68.6 % 68.6 % ±± 9.7 9.7 32.7 % 32.7 % ±± 88 44 % 44 % ±± 5.25.2
0
5
10
15
20
25
30
<50% 51-55 56-60 61-65 66-70 71-75 76-80 >80 21-25
26-30
31-35
36-40
41-45
46-48
0
5
10
15
20
25
30
35
21-25
26-30
31-35
36-40
41-45
46-48
iti d t l tibi l f
05
1015202530354045
28-40 41-45 46-50 51-57
FemoralFemoral tunnel : tunnel : AgliettiAglietti index index
0
5
10
15
20
25
30
<50% 51-55 56-60 61-65 66-70 71-75 76-80 >80
casescases
index in %index in %
AB / AC x 100 AB / AC x 100 68.6 %68.6 %±± 9.79.7
28-40 41-45 46-50 51-5705
1015202530354045
28-40 41-45 46-50 51-57
casescases
index in %index in %
Tibial tunnelTibial tunnel
21-25
26-30
31-35
36-40
41-45
46-48
0
5
10
15
20
25
30
35
21-25
26-30
31-35
36-40
41-45
46-48
iti d t l tibi l f
ProfileProfile AA--PP
3232 % % ±± 88 4444 % % ±± 5.25.2
CorrelationCorrelation position of the tunnels/position of the tunnels/goodgood resultresult
FemoralFemoral tunneltunnelAnteriorAnterior (< 52%) : IKDC : 0 A , 4 B, 9 C(< 52%) : IKDC : 0 A , 4 B, 9 CPosteriorPosterior (> 80%) : IKDC : 0 A, 6 B, 2 D(> 80%) : IKDC : 0 A, 6 B, 2 D
Tibial tunnel ATibial tunnel A--�P �P No No goodgood resultresult if < 30 ou > 50 % if < 30 ou > 50 %
Tibial tunnel (profile) Tibial tunnel (profile) AnteriorAnterior (< 25 %) : IKDC : 4 A, 8 B, 2 C(< 25 %) : IKDC : 4 A, 8 B, 2 CPosteriorPosterior (> 40 %) : IKDC : 8 C ou D(> 40 %) : IKDC : 8 C ou D
Difficulty Difficulty to to seesee the position of the the position of the ligament ligament into into the tunnels on the Xthe tunnels on the X--raysrays
Secondary operations
• Flexion under G.A (6 %)• 16 arthroscopies (8 meniscectomies : 5 med, 3 lat)• 3 arthrotomies (osteophytes)• Removal of 4 screws• 1 tibial osteotomy• 2 iterative ACL reconstructions
Degeneratives lesions
• 8 secondary meniscectomies during 10 years(10 times minor than during the 4 preop years)
• Correlation : Arthrosis / meniscal lesions
• Correlation : Arthrosis / Laxity(Differential laxity : 5.7 vs 8.3 mm)
Les séquelles survenant au niveau du système extenseur, après le prélèvement d'un transplant pour intervention de
type "Mac InJones "
« The sequelae resulting from extensor muscle graft for ACL reconstruction with "Mac InJones" procedure »
JL. Lerat, JL Besse, B. Moyen, E. Brunet-Guedj
Revue de Chirurgie Orthopédique, 1995, 81, 404-410
Patellar height modifications
Preop Post-op Difference
• Blackburne O.72 ± 0.17 0.69 ± 0.16 - O.028• Caton 0.87 ± 0.16 0.86 ± 0.15 - 0.01• Insall 1.11 ± 0.19 1.07 ± 0.20 - O.037
Comparison Comparison of 3 of 3 different different indexindex
No significative modifications for No significative modifications for patellapatella
• Patellar tendon• Anterior knee pain• Flexion• Flexion contracture• Calcifications (29 %)
– sup pole of the patella : 12– Patellar tendon : 4 – inf pole : 6– None of these calcifications requiered repeat surgery
• Quadriceps value
INFLUENCED BY
• Varus • Residual laxity• Pivot shift• Medial meniscus lesions
(57 %) • Long time before
operation (> 4 y)
ARTHROSISARTHROSISARTHROSIS
Evolution of Evolution of arthrosisarthrosis
JOINTSPACE
F-Tmedial
F-Tlateral
F-P F-Tmedial
F-Tlateral
F-P
Normal 76 97 93.5 30.5 78 66.3Remodeled 15.5 0.7 6.5 44.5 13.5 20.5
Stage I 7 1.5 0 11.5 5.3 9.6Stage II 1.5 0.7 0 13.5 3.1 3.6
prepre--opop postpost--opop
%%
StudyStudy of the of the failedfailed cases :cases :Ruptures or elongations of ACL (7 %)
5 ruptures during sport activity2 with poor femoral tunnel positionning
DuringDuring the the samesame time :time :8 ruptures occured at the opposite ACL (4 years after surgery to the other knee)
Literature with long follow-up
• Johnson & Eriksson (1984) 8 years• Aglietti (1992)• Demsey & Tregonning (1993) 9 years• Dejour & Ait si selmi (1995)
(comparisons are not easy : criteria #, follow-up #)
There are few well documented series after 10 years
Role of the extra-articular reconstruction
Not easy to analyse independently of the ACL
• Nothing to be gained from the adding of lateral plasty– Roth (1987)– Strum (1989)– O Brien (1991)
• Reduction of the pivot shift– Jensen Slocum Larson (1983)– Noyes Barber-Westin (1991)– Lerat (1997)
« Influence of a lateral extra-articular plasty on the results of ACL reconstruction with the patellar tendon. Follow-up 4 years »
JL. Lerat, A. Mandrino, JL. Besse, B. Moyen, E. Brunet-Guedj.Revue de Chirurgie Orthopédique, 1997, 83, 591-601
ConclusionsConclusionsConclusions
• Good results if we compare to the literature
• Confirmation of the good quality of patellar tendon as an ACL substitute.
ConclusionsConclusionsConclusions
Quadruple interest of this prospective study :
• Original reconstruction of ACL + Lateral extra-articularreconstruction with a single transplant using the quadriceps tendon and thus preserving the ilio-tibial band and the control of varus stability
• Confirmation of the efficiency of a lateral reconstruction inchronic cases
• Interest of Radiological measurement of the drawer (1979)
• Interest of a early agressive rehabilitation program (1979)
prepre--opop laxitylaxity
Pre-opLAXITY
varusextension
varusflexion
valgusextension
valgusflexion
none 129 116 121 95slight 6 16 14 28++ 2 2 2 11
severe 0 1 0 1