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Resorbable Implants in Knee

Surgery
New Technologies - New Trends
Rodica Marinescu
1
, D.Laptoiu
1
, D.Popescu
2
,
A.Antoniac
2

1
Colentina Clinical Hospital Bucharest,
2
University Politehnica of Bucharest, Romania
Introduction
 “ …..In ACL reconstruction, those elements
that the surgeon is able to influence include
the followings :
 Patient selection
 Graft selection
 Tunnel/graft positioning
 Graft tensioning and fixation
 Treatment of concomitant injuries
 Postoperative rehabilitation...“
T. Swenson and F. Fu 1995 Arthroscopy
Graft Choice
 Chadwick C.
Prodromos
Arthroscopy
2005
 Patellar tendon
remains a
largely used
graft
Physiology
 Graft serves as scaffold -
relatively rapidly incorporated by
the host
 Graft Evolution similar to
avascular necrosis:
 Cell Death: first phase - fibroblasts
die but graft acts as scaffold for new
ingrowths = inflammatory stage.
 Revascularization: New cells grew
into graft = starts @ 20 days and is
completed @ 6 months. Graft
strength << drops as low as 11% !!!!
 Remodeling: Strength slowly returns
but it never returns to its level at the
very beginning. = The fibers
become more organized -
longitudinal pattern.
Importance of Strong Early
Fixation
 Graft fixation is crucial in ACL reconstruction; is the weakest
link in the initial 6- to 12-week period, when healing of the
graft to the host bone occurs.
 The graft must be able to withstand early rehabilitation, which can
consist of forces as high as 450 to 500 N. The fixation can cause
failure due to overstrain or creep during the postoperative period of
healing.
 Early Fixation failure - usually occurs on tibial side.
 Late Fixation failure - Femoral side – position (conflict etc)
Falconiero Arthroscopy 1998
 Found that vascularity and fiber pattern were the same for
graft as in normal ACL after only 6 months which he felt was
the strongest evidence to early return to play.
Fixation Devices
 In recent years, a large number of fixation
devices have been proposed, making the
fixation of a doubled free tendon graft more
reliable than in the past...
 G. Milano et al. 2006 Arthroscopy
Interference –
tunnel
enlargement
Osteolysis

1. First option: Ameliorate
interference fixation
 Better Design
 Use of Composites
Introduction
 The main advantage of biodegradable implants is that
they gradually degrade after they fulfilled their functions
A Weiler
Introduction
 Literature also quotes that the healing process may be
stimulated by the successive loss of the mechanical
properties of the implant during degradation,
corresponding with the increasing loading on the
healing tissue.
 Production and research quickly react to surgeon-
requested design changes for the biofunctionalization
of resorbable implants within the sports medicine field.
Material/Method
 We evaluated several clinical applications comprising
resorbable pins and interference screws for the surgery
of the anterior cruciate ligament, resorbable
augmentation devices for ligaments and tendons.
Method
 Some important information about the bioresorbable
screw degradation in vivo could be obtained after the
retrieval analysis of explanted implant from various
clinical reasons using advanced microscopical technique
like scanning electron microscopy and atomic force
microscopy.
ESEM of retrieved
screw – fissuring and
cavitation at 6 months
Method
 Unfortunately for research purpose but good for
patients, just a few clinical failures of this type of
implants are reported.
CT Image of
resorbed screw
(phantom) at 30
months follow-up
Method
 The degradation behavior cannot be predicted exactly
in vivo, as it is influenced not only by the chemistry and
the implant design but also by the localization of the
implant in the tissue.
Weiler et al: birefringent
fragments found at 24 months
Results
 Osteolytic reactions, which we documented with some
umplants, had clinical consequences in most instances.
Aurabiomat Study
 FEA test were
conducted with
ANSYS v11 software
 The results of the
push-in and pull-out
tests indicate that
both the screw thread
form and cutting
head have a
significant effect on
the holding strength
of the screw.

Material/Method
 The mechanical properties of these polymers were
improved in a series of experimental studies by special
techniques in order to obtain composite biomaterials.
 anorganic particles such as hydroxyapatite are mixed
within the degradable polymer matrix.
 several disadvantages = related to their stiffness
behavior. The degradation behavior of the materials
can be controlled by the production of copolymers and
by the molecular weight of the polymers.
Aurabiomat Study

Biomaterial Faza organică Faza anorganică Sistem de iniţiere
C1

PCL, HEMA, PLA, PEG
UDMA
HAP
TCP
DHEPT
DMABE
Inițiator UV
C2

PCL, HEMA, PLA, PEG
UDMA
HAP
TCP
POB







INSTRON UNIVERSAL LOYD

Biocompatibility/hemotoxcity



Results
 In general, the biocompatibility of the composite
resorbable implants used today is good and the
observed complication rate is very low.
Fused Deposition Modeling



Results
 Fixation should
facilitate graft-tunnel
healing, producing a
normal histological
transition zone
between the host
bone and the graft.
Pending Results
 Resorbable implants should offer good mechanical
properties until incorporation of the graft has occurred.
2. Second option: Cortico-
cancellous Fixation
 Cortical-cancellous suspension fixation achievied with
transcondylar devices seemed to offer the best results in terms of
graft elongation, fixation strength and stiffness…..
 G. Milano - C Fabbriciani 2006 Arthroscopy
Load resistance (N)
979
959
1003
0
400
800
1200
Clark 1998 (Crosspin) Brown 1998 (Transfix) Brown 1998 (Bone Mulch)
Cortico-cancellous Fixation
 ACL surgery should aim
for a good primary fixation
and a simpler
technique.Goal=to obtain
a graft behavior
comparable with the native
ligament
 Cortico-spongious
distribution of load =
better
Transfemoral Fixation
 Advantage: complete tunnel/graft contact-no
device interference.
 Consequence: no tunnel enlargement
Fixation Devices
Fixation
Ultimate
Failure
Load (N)
Stiffness
(N/m
)
Patellar Tendon
Metal interference screw 558 —
Bioabsorbable interference screw (compression systems) 552 —
RigidFix (Mitek) (cortico-cancellous suspension systems) 2005
RetroButton Arthrex (cortical suspension systems) 1083
Soft Tissue (Femoral)
EndoButton (Smith & Nephew Endoscopy, Andover, MA) 1,086 79
RigidFix (Mitek) 868 77
BioScrew (Linvatec) 589 66
RCI Screw (Smith & Nephew Endoscopy) 546 68
Soft Tissue (Tibial)
Intrafix (Ethicon)25 1,332 223
WasherLoc (Arthrotek) 975 87
Tandem spiked washer 769 69
BioScrew 612 91
SoftSilk (Acufex Microsurgical, Mansfield, MS) 471 61
Aim of the Study
 Radiological and functional measurements
after anterior cruciate ligament (ACL)
reconstruction with a bone-tendon-bone
(BTB) graft and transfemoral fixation
Femoral Implants
 Investigations included assessment of bony
integration conditions regarding the use of two
bioabsorbable transfemoral sistems for femoral
graft fixation [TransFix (Arthrex Inc., Naples, FL)
versus RigidFix (DePuy Mitek Inc, Raynham, MT).
42 mm
2
.
7

m
m

3 X 40 and 3 X 50 mm
Surgical Technique
 Transtibial guide
Instrumentation
 Not so simple
Demographic Data
 A total of 22 patients with isolated
complete anterior cruciate ligament
rupture underwent arthroscopic
reconstruction via two different fixation
methods using patellar bone
autografts.
 Averg. 31 years old (19-43) ,
Male:female ratio 1:1
 Graft size 10mm / 30 mm-40 to 50 mm-
25 to 35 mm
 Cartilage injuries 10 cases (2 cases with
mozaicplasty for Outerbridge IV)
 Pre-injury sport level – high risk
competitive sports grade 8, 9
Tegner scale
Overall Clinical Results
Technique BTB Preop Lysholm Postop Lysholm IKDC
Rigidfix 57,4 94,4 A 8
B 2
C 2
D 0
Transfix 57,3 95,4 A 7
B 2
C 1
D 0
Results
 MRI + RX
Results
 The femoral tunnel was almost
invisible in all patients on Xrays;
 Fibrous fixation with incomplete
resorbtion was noted in two Transfix
cases on MRI.

Biological advantage
6 m 10 y
Results
 There was no significance between the two
groups in terms of laxity testing at one year
follow-up.
 Tibial tunnel placement was physiological in
90% and femoral in 96% of the cases
Complications
 At surgery time, two cases of
RigidFix versus five of
Transfix had intraoperative
complications (incorrect
placement of pins, guide wire
rupture etc).
Iliotibial friction
 Insufficient soft
tissues release
 Cossey Arthroscopy
2006
 +Intraoperative
direct visualization
with the scope
Pin protrusion
 Technical error?
 Cossey
Arthroscopy 2006
 Insufficient
insertion
 Too oblique
insertion – possible
slippage



Twisting nitinol wire
 Single use
 Yeong Seuk Lee
KSSTA 2008
Pin fracture (ST)
 Canulated , longer device
 Hard bone
– Cossey
Arthroscopy 2006
Pin deformation
 More in ST
than BTB
Malposition
 Ram Misra, Arthroscopy 2006
Even so…
0
15
4
4
12
3
6
0
0
5
10
15
20
25
30
Normal Nearly normal Abnormal Severely abnormal
pre-op
post-op
 IKDC score demonstrated favorable functional results (A and B
class, normal – nearly normal) with no statistical connection
with the intraoperative complications.
Discussion BTB
 Clinical Evidence for Early Return to Play
 Effect of early versus late return to vigorous activities on the
outcome of anterior cruciate ligament reconstruction. Glasgow
et al. American journal of Sports Medicine. 1993.
 Effect (mean 5 months) versus late (mean 9 months)
return to vigorous cutting activity on long-term outcome
of anterior cruciate reconstruction was studied in 64
patients.
 By clinical examination, subjective evaluation, KT 1000
there was no difference in either group.
Discussion BTB - ST
 Biological Healing at attachment site
 In the early stages the most likely place of failure will be
at the fixation site in the bone tunnels.
 Tendon-healing in a bone tunnel: A biomechanical and
histological study in the dog. Rodeo et al. JBJS 1993.
 20 adult mongrel dogs and looked for pullout strength
of ST tendon fixed into a tibial tunnel drill hole similar to
BTB. Found that up to 8 weeks tendon pulled from
bone but after 12 weeks the graft torn midsubstance.
 ST Compared to BTB healing which takes on fracture healing
type characteristics = healing - typically occurs at 6 weeks.
 Transfemoral Fixation = circular contact graft -tunnel
Discussion BTB TF Fixation
 Conclusion = Return to Play Criteria
 Return to play based on full range of motion with “good”
muscle strength and muscle balance.
 Can compare side to side hamstring and quad strength
 at least 85% compared to contralateral of quad and 100% of
hamstring
 Functional testing can provide a global assessment of
the ability of the knee to perform sports-related
activities
 Can use single leg hop, timed single leg hop for 3-5 m, and the
vertical jump for functional testing (85% compared to opposite
side).
Conclusions
 Femoral fixation with
bioabsorbable cross-
pins shows a biological
bony incorporation of a
patellar tendon graft.
 It allows rapid
rehabilitation protocols
corelated to high profile
sports
Thank You!