TOTAL HIP RESURFACING ARTHROPLASTY: THE ACTUAL ROLE
S. Zanasi, M. Pastina
Villa Erbosa Hospital, Gruppo San Donato, Orthopaedics Dept. Bologna, Italy
The hip surface replacement concept remains attractive because the femoral head and
neck are preserved, the femoral (thigh) bone is loaded in a more natural way, the large
femoral shell enhances the stability and ROM of the surface replacement arthroplasty and
prevents dislocation. Preservation of bone stock is especially attractive for young, active
patients who are likely to outlive their first hip arthroplasty operation and will have a new
arthroplasty operation during their lifetime. The theoretical advantages of the resurfacing
metal-on-metal articulation are: no bone resection (total conservation of the femural head),
recovery of normal ROM, less wear, less bone rebsorption, less leg length discrepancy
and offset problems, an anatomical reconstruction, avoiding of "stress-shielding", maximal
proprioceptive feedback, minimal risk for dislocation, easier revision surgery, normal
femural loading. In particular the ReCapTM Femoral Resurfacing System is unique among
femoral head resurfacing devices. The implant design and surgical technique minimize the
amount of resected bone and provide intraoperative versatility. Competitive designs
remove more bone circumferentially from the femoral head , which can increase the
chance of notching the femoral neck, one of the reasons for component failure. The
ReCapTM Femoral Resurfacing System utilizes anatomical geometric limits to define a
technique that removes only the bone necessary to apply a thin, yet durable, cobalt
chrome, femoral head resurfacing component over the articulating surface. Should revision
to total hip arthroplasty ever become necessary, revision to a total hip prosthesis may be
as simple as preparing for, and implanting, primary hip implants. The femoral neck is
resected and a traditional "primary" hip stem is put in place. Biomet’s ReCapTM Femoral
Resurfacing System is non-invasive to the femoral canal, reducing intraoperative blood
loss, and leaving a virgin femoral canal should future total hip arthroplasty become
necessary. On the basis of our experience (126 RHA reviwed from 6/2005 to 6/2008) in
confront of worldwide cases series our indications for resurfacing are lightly more
restrictive: mainly young, active patients, usually male under 60 years of age and female
under 50 years, who will meet also the other requirements for total hip replacement, i.e.
severe limitation and stiffness in the hip joint. It is important that the patient does not have
any risk factors that may increase the risk of failure of the surface hip replacement
operation. Such risk factors are: osteoporosis; head deformities of the femoral head,
where restoration of leg length and offset is not possible; previous operation on the hip,
especially an operation that left the neck of the thighbone deformed; patients with bone
cysts (voids) in the femoral heads and necks and patients with very small and /or severely
deformed hip joints. Further contraindications at total hip resurfacing and resorting to MIS
THA with neck preservation are: secondary hip arthritis due to trauma, Perthes disease,
epifisiolysis, aseptic necrosis — Amstuz stage greater II - of femural head , reumatoid
arthritis, head femural deformities. In ALL these cases a modular big ball head can be
used with a stemmed femoral implant with thesame metal-on-metal properties as the total
1
hip resurfacing implant, and big ball head advantages . Complications are mainly due to
neck fracture: in the published reports about the modern surfacehip replacement this
complication occurred in about 0.8 to 1.0% of all patients. In our yet selected cases for hip
resurfacing, neck fracture unfortunely occurred, without any documented cases of
impingement, notching, malpositioning, in 5.5 % of the implants (7out of 126) . Usually it
occurs within six months after surgery (6 out of 7 occurs within three ms after surgery);
the first signs are pain. In some patients it occurs without a previous trauma. Theoretically
a femoral neck fracture can only occur with a poor technique or improper indications
(elderly people — osteoporosis) but in our case we did not find other elements probably
predisposing than fast and intensive recovery of the previous work requiring prolonged
standing or setting, with complete weight bearing within 20 days postop. Heterotopic
ossifications are equally frequent as after total hip replacement: predisposed are same
categories of patients as the patients at risk after after total hip replacement: in our
reviewed cases we found only 9 cases out of 126, and all cases were confined within I to ll
degree, according to Brooker. An other particular element to be underlined is the high
blood levels of metal traces: the surface replacement shells have larger surfaces than
conventional metal on metal total hip prostheses and, at least theoretically, they will
produce more metallic particles and other corrosion products than conventional metal on
metal total hip prostheses. Consequently one may suppose higher levels of these metals
in the blood and urine of patients with surface hip replacements. Our report showed that
patients with hip surface replacements had very high values of Chromium and Cobalt in
their blood and urine in the first year postop. These values, according to Jacobs studies
(Jacobs 1996). were also 3 - 4 fold higher then the already high values of these metals in
patients with metal on metal total hip prostheses. Patients with bilateral surface
replacements have had still higher serum & urine levels of these metals. These elevated
values of trace metals were found in patients who have had their surface replacement
surgery less than two years ago. It is known that the wear of metal on metal surfaces is
very high during the initial period. It may be that these very high serum levels of the trace
metals only reflect the initially high wear rates of metal on metal bearing couples. Although
the use of metal on metal bearing couples in the surface hip replacement eliminates the
production of polyethylene particles, there is concern about the high blood concentrations
of the metals that are part of the alloys used for fabrication of surface shells. The
importance of these very high serum & urine levels of the trace metals for the development
of cancer is not known. (Merrit 1996). Patients with impairment of kidney iiinction (urea
blood levels and creatinin clearance levels too high) should not have modern surface hip
replacement with metal-on-metal shells. Finally the actual role of hip resurfacing according
to our 8 ys longstanding cases series (last review from 2004 to 2008) should be to confine
only to very young male and female people affected by primitive and secondary OA, that is
strongly motivated and strongly require for resurfacing and that is learned on the possible
complications that should take to revisiting the femoral component of the THA.
2
METAL ON METAL TOTAL HIP RESURFACING ARTHROPLASTY WITH HIGHEST
DIAMETER HEADS IMPLANT COMPONENT IN YOUNG PATIENTS
S. Zanasi, M. Pastina, F. Lenzi
Villa Erbosa Hospital, Gruppo San Donato, Orthopaedics Dept. Bologna, Italy
Encouraging results and new implant developments have allowed total hip replacement to
be performed in increasingly younger and more active patients. In young patients,
however, outcomes are not comparable to those seen in older patients. The inflammatory
reaction to polyethylene wear particles is one of the main causes of aseptic loosening and
subsequent revision surgery and can limit the longevity of an arthroplasty in young and
active patients. Even though ceramic femoral heads have been associated with lower in
vivo polyethylene wear rates, which have been variable and up to 50% lower than with
metallic heads metal—on-metal bearings have been reintroduced with improved materials,
design, and manufacturing . The most noteworthy advantages of the use of largest head
size MOM THA include very low wear and subsequent osteolysis, increased range of
motion to reduce the risk of impingement and luxation and the potential to monitor implant
performance by serial assessment of metal ion levels. Current metal-on-metal bearings
are based on cobalt-chromitun-molybdenum alloys with varying carbon contents. Such
bearings are self-polishing. Linear wear rates remain at the level of a few micron a year.
These features seem to improve clearly the tribology and longevity of the THR. In
particular the recovery of the quite complete ROM and the excellent joint stability after
emiresurfacing hip arthroplasty (big head effect) could be one of the main factors favoring
a high activity level compared to conventional THA, furtherly by limiting the episodes of
dislocation and increasing the suction effect between the joint components, allowing young
patients sport activity too. It is nevertheless difficult to ascertain the long-terrn effect of
intense sports activity on the fixation of osteo-integrated implants (cups) and cemented
components (femoral stem). Although the advantages of low wear and increased range of
motion have made MOM THA an attractive bearing surface option, more widespread use
of MOM bearing surfaces has been tempered with concern for increased metal ion levels
and hypersensitivity reactions. All bearings have disadvantages, and a metal-on-metal
bearing is no exception. Concerns exist regarding the generation of metal ions seen in the
blood and urine of patients with metal-on-metal implants. These elevated metal ions have
theoretical, although not proven, risks related to carcinogenic and biologic concerns.
Additionally, concerns exist regarding hypersensitivity, increased costs. Specific patient
selection issues arise with metal-on-metal implants. The current generation of implants
has only early and mid—term results available, with no long-terrn series yet published.
According to current knowledge, this metal-on-metal bearing still represent, with aluminaon-alumina and highly crosslinked PE, a competitive and comprehensive option to improve
THA longevity. The real pending problem concerns the frequency and above all the
intensity of metal delayed hypersensitivity reaction and their potential effect on implant
loosening. Therefore, although a metal-on-metal bearing may be considered a viable
altemative to either polyethylene or ceramic implants, outstanding and unresolved issues
continue to exist with this bearing, as they do with the altematives.
3
LARGE AND MASSIVE ROTATOR CUFF TEARS TREATMENT BY ORTHOADAPT
S. Zanasi, M. Pastina, F. Lenzi .
Villa Erbosa Hospital, Gruppo San Donato, Orthopaedics Dept, Bologna, Italy
Large rotator cuff tears, a common source of shoulder pathology, are often the cause of
debilitating shoulder pain, reduced shoulder function and compromised joint mechanics.
Despite surgical advances, there is a high rate of recurrent tears ranging (20-70%) after
surgical repair, particularly for chronic, large to massive cuff tears. The inability to obtain a
high healing rate in these tears has fueled investigation in the use of extracellular matrix
(ECM) derived materials as a scaffolds for rotator cuff tendon repair and regeneration.
Over the past few years, many biologic patches have been developed to augment repairs
of large or complex tendon tears. These patches include both allograft and xenografts.
Regardless of their origins, these products are primarily composed of purified type I
collagen. An extensive amount of basic science and preclinical models have demonstrated
that an ECM patch may offer improved healing rates with a biomechanical profile that
nearly reproduces the features of the native rotator cuff tendon. Many factors should be
considered when choosing an augmentation patch including tissue origin, graft processing,
cross-linking, clinical experience, and physical properties. The OrthADAPTTM Bioimplant
from Pegasus Biologics, Inc. is a FDA cleared, decellularized, biologic scaffold that fortifies
and promotes tissue ingrowth. It is intended for the reinforcement, repair and
reconstruction of soft tissue in orthopedic procedures. The bioimplant is stabilized and
sterilized using proprietary technologies which make it resistant to premature enzyme
degradation, biocompatible and safe. Preclinical studies have shown that the OrthADAPT
Bioimplant—FX integrates with host tissue by revascularizing and supporting the
remodeling cascade to lay down new collagen and provides a reliable scaffold throughout
the healing process. The OrthADAPT® Bioimplant is a highly organized Type I collagen
scaffold that we have mainly used for the reconstruction, augmentation, and reinforcement
of rotator cuff soft tissue. Clinical results demonstrated that this bioimplant is an effective
scaffold, does not produce any clinically significant inflammatory responses and provides
strength throughout the healing process for rapid, controlled remodeling at the implantation
site. Excellent augmentation/reconstruction outcome of the rotator cuff tendon have been
achieved in the reviewed 12 cases of largest and massive injury (type III, IV of Walch,
grade 2,3 according to Mansat) : 6 month post-op MRI demonstrated complete continuity
restoration of the 12 rotator cuff reconstructed using the OrthADAPT® bioimplant. At 6
months post—op all patients do very well, being pain-free, taking no medications and
sleeping without shoulder pain. : average AROM (active range of motion) is quite complete
(l60° forward flexion, l60° abduction, 40° external rotation, lntemal rotation to midback) as
well as strength restoration is quite good (Supraspinatus 4+/5, Infraspinatus 4/5, Negative
ER lag sign, Subscapularis 5/5). The OrthADAPT® Bioimplant provided beneficial
reinforcement of this chronic, massive retracted rotator cuff tear.
4
BIOCERAMICS IN SEVERE BONE LOSS DEFECT MANAGEMENT
IN REVISION TOTAL KNEE ARTHROPLASTY
S. Zanasi, M. Pastina, F. Lenzi
Villa Erbosa Hospital, Gruppo San Donato, Orthopaedics Dept. Bologna, Italy
The alternatives available for management of bone defects in revision total knee
arthroplasty include prosthetic augments, autograft, allograft, and the use of bone cement.
The selection of the augment technique should be based on the defect size, the patient
age and life expectancy, and an assessment of the documented clinical results of each
method. Prosthetic augments will address the vast majority of defects. The use of allograft
is primarily indicated in the setting of major bone loss in revision knee arthroplasty:
massive bone defects are challenging problems in revision knee surgery and when defects
are large and uncontained (without a cortical rim), structural allografts may be used to
provide support for femoral and tibial components. The use of autograft is appropriate in
the management of small defects in primary arthroplasty. Bone cement can be used for
small defects if the stability of the implant is not compromised by the defect. A new tools,
ENGIPORE and FINBLOCK a bioceramic bone substitutes in granules and blocks can find
an altemative indication in management of all three types of femoral and tibial defects
according to Engh classification. The benefit of the bioceramics consists of creating a
perfect synergy between the biochemical stimuli and the structural ones facilitating the
neo-osteosintesis. The new generation hydrossiapatitis biomaterial, in contact with the
physiological fluid, create the ideal microenvironment to receive the necessary biological
stimuli for the bony development. The interconnected porosity plays a decisive role in the
osheointegration process allowing a total communication between the biomaterial and the
surrounding environment favoring the bony formation. By developing an innovative
process of production based on the nanotechnology, a biomaterial with a completely
similar architecture to that one of the natural bone has been come true. This particular
structure confers to the biomaterial a porosity that catches up 90%: it means that the new
bone finds the ideal space for its natural formation. The high porosity joined to the
microstructural morphologic features give ENGlpore amazing ability to absorption of the
physiological fluid. Thanks to this "sponge effect”, just it has been applied in situ,
ENGIpore absorbs, for all its thickness, those bioactive proteins and growth factors that
render more effective and fast the colonization and the differentiation of the cells deputies
to bony regeneration. In this way ENGIpore in a short time acquires an increasing stability
and mechanical resistance until complete integration vdth new bone. We present main
exemplificative applications of the bioceramic in the treatment of different severe bone
defect in revision total knee arthroplasty
5
HYALOGRAFT-C ACI VERSUS BIOSEED-C IMPLANTATION FOR CARTILAGE REPAIR
AT 3 YS F.UP IN SPORTSMAN
S. Zanasi, M. Pastina, F. Lenzi
Villa Erbosa Hospital, Gruppo San Donato, Orthopaedics Dept. Bologna, Italy
Recent technologic improvements have aimed to overcome the intrinsic technical
disadvantages of ACI by using cartilage tissue engineering grafts developed with threedimensional scaffolds or matrices that contain autologous chondrocytes for cartilage
regeneration. Biomaterials that have been used include hyaluronan and collagen type I ,
and safety and effectiveness have been demonstrated for cartilage repair. The aim of work
was to analyze clinical effectiveness of repairing of focal articular cartilage defects using a
modification of ACI based on autologous polymer-based three-dimensional chondrocyte
grafts.(BioSeed-C —a polyglycolic/polylactic acid and polydioxane based material), and
culture-expanded autologous chondrocytes, suspended in fibrin, that are seeded and
dispersed within the matrix., versus Hyaluron-C as a stable, resorbable, three-dimensional
matrix for tissue engineering, particularly for orthopedic application.We evaluated the cellseeded, two-component, gel-polymer compositediyaluran acid in the arthrotomic and
arthroscopic treatment of post-traumatic and degenerative cartilage defects in a group of
patients suffering from chronic post-traumatic or degenerative cartilage lesions of the
knee. Clinical outcome was assessed in two omogenous group of 50 patients with a
clinical follow up at 3, 6, 12, and 24 months after implantation. Evaluations were based on
the modified Cincinnati Knee Rating System, the Lysholm Score, the Knee Injury and
Osteoarthritis Outcome Score, and the current health assessment form of the International
Knee Documentation Committee, as well as histologic analysis of second-look biopsies.
The findings reported demonstrate a number of advantages of this second-generation ACI
Bioseed-C approach over the Hyalograft-C procedure. Specifically, by using a stable,
three-dimensional matrix, seeded chondrocytes are retained more efficiently at the site of
implantation, which should promote integration between the neo-cartilage and the
surrounding host articular cartilage tissue. A critical feature of the technology is the use of
a gel carrier for the seeded cells to perfuse into the three-dimensional polymer scaffold, a
method that essentially anchors the cells within the mechanically stable scaffold while
providing an environment that has been shown to enhance the chondrocyte phenotype, In
addition to favorable clinical scores, Ossendorf and coworkers also reported histologic
results on second-look biopsies after implantation of the gel-polymer based chondrocyte
graft BioSeed-C. The engineered graft showed mostly hyaline cartilage with some
fibrocartilage, and presence of viable chondrocytes and absence of calcification,
apoptosis, necrosis, and formation of a fibrous repair tissue. However, there was
unevenness in the graft in terms of matrix staining, suggesting that the neo-cartilage may
not be homogeneous, which could result in compromised mechanical properties. It is
noteworthy that the histologic analysis was derived from 18% of the patients who
underwent second-look arthroscopy as a result of grinding, catching, pain, or swelling of
the knee, a rate comparable to that in other studies reporting rates of revision surgery
between 0% and 25% . Failure rate with the BioSeed-C procedure was only 2% (1/50),
6
which is considerably lower than the 10% reported for 2nd-generation ACI Hyalograft-C.
The significantly reduced operating time and the potential for arthroscopic application are
additional benefits of the procedure reported here. In particular, the improvement in graft
fixation presents the possibility to repair defects that are larger than focal lesions, which
currently are the sole indication for ACI. Compared with the use of native matrix materials
alone, such as collagen and hyaluronan, the cells are better retained in the mechanically
more stable BioSeed-C procedure. Another advantage is that no cover material, such as
the periosteum used in the original ACI procedure, is required. It should be noted that in
the study conducted by Ossendorf and coworkers no specific selection of osteoarthritic
patients was conducted using the more standard International Cartilage Repair Society
scoring system, and the classification of osteoarthritis was done primarily based on
radiographic observations. A more targeted study in patients with defined osteoarthritis is
clearly required to test the applicability of the BioSeed-C procedure for larger sized
cartilage repair of osteoarthritic lesions. These findings suggest that implantation of
autologous chondrocyte-seeded BioSeed-C is an effective treatment option for the
regeneration of post-traumatic or osteoarthritic defects of the knee.
7
METAL SENSIVITY IN PATIENTS WITH TOTAL KNEE ARTHROPLASTY
Stefano Zanasi, M.D.
Third Division – MIS Hip And Knee Joint Arthroplasty Operative Centre,
Orthopaedics Department, Gruppo San Donato, Villa Erbosa Hospital, Bologna, Italy
Mail: zanasis.orth@alice.it
-
Cell. 3357374509
INTRODUCTION
For many patients, the metals used in contemporary joint replacement surgery produce
little or no reaction from the immune system. In a small but significant percentage of
patients, however, a very rapid, T cell-mediated, allergic response may occur and
ultimately may lead to implant failure . Probably is said that more than half of all TKA
revisions are because of hypersensitivity to the cobalt-chromium/nickel alloy used in the
failed knee implants. Fortunately the incidence of reactions to implanted metals
approaching just 1% of the population does not match the 10-15% rate of dermal
sensitivity with nickel sensitivity having the highest prevalence (14% vs Co-Cr 2%). All
metals in contact with biological systems undergo corrosion: this electrochemical process
leads to the formation of metals ions , particulates, oxides, insoluble salts that rapidly
interact with host proteins in a process known as haptenization: the combination of
proteins and degradation products may become immunogenic, eliciting the hypersitivity
reaction to implant devices with increasing pain and loosening. The paper reports on a
study to determine the clinical benefit of patients screening who should predisposed to
symptomatic metal sensitivity in implanted TKA
METHODS AND MATHERIALS Two cohorts of 50 patients with primary navigated TKA
were studied: one homogeneous group (I) of 50 navigated primary TKA was performed
from 2002 to 2004 without resorting to data collecting for metal sensitivity. 8 out of 50
patients claimed for painful in TKA longer than six months postoperative and after all
investigations they were tested for sensitivity to any of the metals too: 6 out of 8 presented
positive patch testing and modified lymphocyte stimulation test (mLST). A second
homogeneous group (II) of 50 patients with navigated primary TKA was performed from
2005 to 2007: all patients asked for anamnestic potential positivity for metal
hypersensitivity (N°12) were tested preoperatively for sensitivity to Ni, Go, Cb (patch
testing) and those who tested positive (I\i°8) for sensitivity to any of the metals were
retested postoperatively; in 2 out of these 8 pts. were presented other meta! implants that
have been performed in different joint/areas (skull, teeth) so that we proceed with normal
TKA as well as for three patients whose patch testing were only lightly positive . Other 3
patients were treated by AS COLUMBUS TKA THAT IS A MULTILAYER RESURFACING
of both components with total barrier to Cr,Cb,Ni.
8
RESULTS. Objective and subjective sign and symptoms have been registered in these 5
pts. Of the group II: discomfort, erithema, light swelling and skin changes in the area of
implant or in some cases patients reported general malaise, fatigue or weakness (N°3). in
the navigated group I with pain and loosening needing TKA removal al: 5 implants were
optimally positioned (varus—valgus 0 or +/—1°). sized and balanced, all 5 patients came
from a specific geographical area with highest pollution due to steel factories presence;
pain and giving-away/ loosening were progressively increasing and finally after removal
and replantation by AD COLUMBUS B—Braun primary TKA patch testing as well rnLSA
were negative and articular fluid were found free of lymphocytes cells.
CONCLUSIONS The prevalence of metal sensitivity among patients with a well functioning
implant is approximately 25% roughly twice that ot general population. The average
prevalence of metal sensitivity among patients with a unclear but poorly functioning painful
even though well positioned navigated implant was approximately 60%, that is six times
that of general general population and approximately two to three times of all patients with
a metal implant. This study confirms that in patients with a TKA the frequency of positive
patch testing is higher than in the normal population and the presence of symptoms of
metal allergy before implantation should be taken into account as a potential risk factor for
TKA failure. Patients presenting signs of an allergenic reaction should be evaluated for
sensitivity. Patients who have had an allergenic reaction to a metallic device or to jewelry
are more likely to have a reaction to an implant device than are those with such history. At
this time there is no evidence that there is an increased risk of a reaction to an implanted
device in patients who have skin patch sensitivity but no history of reaction to metallic
materials. Finally, however, these data do not prove a causal effect due to the fact patients
are sensitive because the device failed, whether the device failed because the patient had
e preexisting metal sensitivity.
9
INNOVATIONS IN KNEE RESURFACING IMPLANT ARTHROPLASTY:
NEW TRENDS IN OPERATIVE TREATMENT
AND CHANGES IN PERI-OPERATIVE MANAGEMENT
Stefano Zanasi, M.D.
Third Division – MIS Hip And Knee Joint Arthroplasty Operative Centre,
Orthopaedics Department, Gruppo San Donato, Villa Erbosa Hospital, Bologna, Italy
Mail: zanasis.orth@alice.it
-
Cell. 3357374509
The human knee joint can sustain damage due to injury, or more usually osteoarthritis, to one, two
or all three of the knee compartments: the medial femoro-tibial, the lateral femoro-tibial and the
patello-femoral compartments. When pain associated with this damage is unmanageable using
non-surgical techniques, knee replacement surgery might be the most appropriate course of
action. This procedure aims to restore a pain-free, fully functional and durable knee joint. Total
knee replacement is a well-established treatment modality, and more recently partial knee
replacement, more commonly known as uni- or bi-compartmental or biuni-compartmental knee
replacement, has seen resurgence in interest and popularity. In elderly as well as in younger
patient our choice is to reconstruct only the diseased compartment not substituting the whole knee
in order to maintain best proprioceptivity, comfort, performance. In particular the principal feature of
the Bi-UNI is the use of 2 femoral and 2 tibial indipendent components and the particular feature of
the Bi-compartmental knee replacement is either the use of 2 femoral - that is two independent
throclear and condylar components – and 1 tibial plate component or the use of a monolithic
design of the Journey Deuce device (DEUCE, Smith&Nephew) that resurfaces the medial and
10
patellofemoral compartments of the femoral bone. In our experience the advantages of this
procedure are the same as those regarding UKR: preservation the intercondylar eminence with the
cruciates, rotational axis respect, bone stock respect, normal patellar level and tracking, normal
joint kinematic and gait reproduction, leg’s morphology respect, proprioception maintanance .
Obviously a surgical mistake due to the difficulty of the technique or due to the loosening of a
component is calculated. Combined with the use of minimally-invasive surgery techniques, genderspecific prosthetics and computer-assisted navigation systems, orthopaedic surgeons are now able
to offer patients partial combined knee replacement/resurfacing procedures that are associated
with (i) minimal risks during and after surgery by avoiding fat embolism, reducing blood loss and
minimizing soft tissue disruption; (ii) smaller incisions; (iii) faster and less painful rehabilitation; (iv)
reduced hospital stay and faster return to normal activities of daily living; (v) an improved range of
motion; (vi) less requirement for analgesics; and (vii) a durable, well-aligned, highly functional
knee. With the ongoing advancements in surgical technique, medical technology and prosthesis
design, knee replacement surgery is constantly evolving.
11
BICOMPARTMENTAL DEUCE RESURFACING KNEE ARTHROPLASTY:
EARLY RESULTS
Stefano Zanasi, M.D.
Third Division – MIS Hip And Knee Joint Arthroplasty Operative Centre,
Orthopaedics Department, Gruppo San Donato, Villa Erbosa Hospital, Bologna, Italy
Mail: zanasis.orth@alice.it
-
Cell. 3357374509
INTRODUCTION
In the past, treatment of knee osteoarthritis has been limited to unicompartmental knee
replacement or total knee arthroplasty (TKA). Neither option is well suited for the active
patient with midstage osteoarthritis of the medial and patellofemoral compartments. A
revolutionary bicompartmental design is now available specifically to address the joint
involvement of these patients with a monolithic device that resurfaces both the medial and
the patellofemoral compartments, while leaving the lateral bone areas and cartilage intact.
In addition to bone conservation, the anterior and posterior cruciate ligaments are
preserved, resulting in more normal knee function. A minimally invasive surgical technique
is well suited for this procedure and allows for a quicker recovery when compared to TKR.
Treatment specifically targeted at the pathologic compartments without loss of normal
bone and ligaments results in a rapid return to normal activity, increased stability, and
decreased pain.
METHODS
75 patients with medial and patellofemoral pathology were implanted with the Journey
Deuce bicompartmental device by one surgeon (S.Z.) from December 2008 to December
2010. There were 31 males and 44 females, aged 40-84 years old (average 56 years old).
All cases were of primary osteoarthritis: in 4 patients with bilateral involvement surgical
procedure were concurrent bilaterally performed. All patients had pain and not severe
limited range of motion (ROM) of knee. MRI scanning a operative view showed neither
cartilage and meniscus damage at the lateral compartment neither LCA damage in all
cases. The disease course was 1 to 4 years (average 2.2 years).
RESULTS
The operative time was (75.0 +/- 21.7) minutes. The blood loss was (280 +/- 130) mL. The
CPM practice started 2 days after operation. All incision healed by first intention. Thirtytwo patients were followed up 12 to 18 months (average 14.2 months). Hydrarthrosis
occurred in 8 cases at 3-6 months postoperatively. Two weeks’ postoperatively, most
patients were able to walk with only a minimal limp and without the aid of assistive
12
devices. Patients had no patellofemoral pain or clunking sounds. Lateral joint line
tenderness was not present. Blood loss was clearly less than that in the TKR patients,
because none required a blood transfusion. There were statistically significant differences
in KSS score between preoperation and 3, 6, 12 months after operation (P < 0.05),
between 3 months and 6, 12 months after operation (P < 0.05); there was no statistically
significant difference in KSS score between 6 months and 12 months after operation (P >
0.05). There were statistically significant differences in pain score between preoperation
and 3, 6, 12 months after operation (P < 0.05), and in ROM between 3 months and 6, 12
months after operation (P < 0.05). There was no statistically significant difference in ROM
between preoperation and 3 months after operation (P > 0.05).
CONCLUSIONS
Patients reported a high level of satisfaction following Journey Deuce implantation. The
advantages offered by a bicompartmental arthroplasty uniquely meet the demands for
normal kinematics and proprioception that allows for a high level of patient satisfaction
following arthroplasty and a reduced level of pain. Such devices can benefit younger
patients by retaining both cruciate ligaments, thus maintaining stability to the knee. Elderly
patients can equally benefit by the reduced pain and blood loss and therefore a much
easier postoperative rehabilitation. In addition, bicompartmental arthroplasty has also been
used as an alternative revision option for a patient with a loose unicondylar knee.
13
aniceforo@tin.it
RICOSTRUZIONE CON ACT vs MSCs NELLE LESIONI CARTILAGINEE A STAMPO DEL
GINOCCHIO E DELLA CAVIGLIA: INDICAZIONI E RISULTATI
ACT VS MSCs IN CARTILAGE DEFECTS RECONSTRUCTION: INDICATIONS AND
EARLIER RESULTS
Stefano Zanasi, M.D.
Third Division – MIS Hip And Knee Joint Arthroplasty Operative Centre,
Orthopaedics Department, Gruppo San Donato, Villa Erbosa Hospital, Bologna, Italy
Mail: zanasis.orth@alice.it
-
Cell. 3357374509
In campo ortopedico, lo sviluppo della bioingegneria e dell’ingegneria dei tessuti, apre nuove
prospettive alla realizzazione della 'MEDICINA RIGENERATIVA', il cui obiettivo è la ricostruzione
biologica dei tessuti dell'apparato locomotore. In tale ottica, si inserisce il TRAPIANTO
AUTOLOGO DI CONDROCITI, utilizzato per la riparazione di difetti cartilaginei. Questa emergente
opzione terapeutica richiede il controllo della tecnica di coltura di condrociti da un lato e
competenze chirurgiche dall'altro. Una frontiera ancora più innovativa è rappresentata dalla
possibilità di utilizzare una nuova tecnologia per una rapida produzione, direttamente in sala
operatoria, di emoderivati autologhi utilizzabili nella pratica clinica per la rigenerazione tissutale:
GEL PIASTRINICO (FATTORI DI CRESCITA) E CELLULE STAMINALI DI MIDOLLO OSSEO. In
particolare
CELLULE
STAMINALI
DI
MIDOLLO
OSSEO
AUTOLOGO
CONCENTRATO (BMAC) si ottengono in soli 15 minuti partendo da midollo osseo aspirato da
cresta iliaca (60 o 120 ml) attraverso ciclo di centrifugazione operato da una centrifuga di piccole
dimensioni, da usare in sala operatoria senza necessità di personale specializzato. La procedura
elimina i globuli rossi e il prodotto finale contiene: cellule staminali emopoietiche, cellule staminali
mesenchimali , progenitori vascolari, cellule immunitarie e piastrine, fattori di crescita (attivazione
con trombina autologa) in un volume finale di 10 o 20 ml . Questo studio su una popolazione di 55
pazienti affetti da coin lesion di IV grado di Outerbridge interessante rotula, CFM, CFL, emipiatto
tibiale laterale, domo astragalico non inferiore a 3cm2 e non superiore a 9cm2 riporta che, in
seguito a inoculo del concentrato di midollo osseo (BMSCs) su uno scaffold di acido ialuronico
esterificato (HYAFF-11): non si osserva alcuna complicanza locale nè sistemica; si ha, come da
controllo con RMN 1.5T ad 1, 3, 6, 12 mesi f.up, la riformazione di tessuto cartilagineo, ottenendo
ICRS e AOFAS scores, del tutto sovrapponibili, se non superiori, almeno a breve termine, alla
consolidata tecnica del trapianto di
condrociti autologhi; la tecnica presenta soprattutto il
14
vantaggio di un unico tempo operatorio, senza necessità di prelievo di cartilagine e clonazione
della stessa in centro di coltura specializzato con reimpianto successivo dopo circa 30 gg.
aniceforo@tin.it
ACT VS MSCs IN
EARLIER RESULTS
CARTILAGE DEFECTS RECONSTRUCTION: INDICATIONS AND
Stefano Zanasi, M.D.
Third Division – MIS Hip And Knee Joint Arthroplasty Operative Centre,
Orthopaedics Department, Gruppo San Donato, Villa Erbosa Hospital, Bologna, Italy
Autologous chondrocyte implantation is widely considered state of the art in cartilage regeneration,
having shown its ability to regenerate reparative tissue with physical characteristics similar to
healthy cartilage. Furthermore, the use of a tissue-engineered biomaterial composed of autologous
chondrocytes grown on a scaffold entirely made of HYAFF-11 enhanced applicability of the
technique, permitting a completely arthroscopic procedure in the knee and ankle . Nevertheless,
the need for two surgical operations and the high costs resulting from cell expansion are major
drawbacks of the technique, which may never be overcome. Furthermore, chondrocytes are
differentiated cells, which are able to regenerate only a cartilagineous structure.
The rationale of this study is based on the hypothesis that bone marrow-derived cells may be used
for osteochondral lesions of the knee and talus repair, overcoming all the drawbacks raised from
autologous chondrocyte implantation.
We then conducted a prospective clinical study to
investigate the validity of the one-step mini-open or arthroscopic technique, based on bone
marrow-derived cells, in osteochondral lesions of the knee or talus repair, in terms of ICRS and
AOFAS score; the influence of scaffold type, lesion area, previous surgeries, and lesion depth on
ICRS and AOFAS score; and the ability to regenerate osteochondral tissue, using MRI, second15
look arthroscopies, and histologic analysis. Although the lack of a control group is a limitation of
the study, nevertheless, there is general agreement in the literature that, in the type of lesion
considered in this study (Type II lesions), surgical treatment is mandatory . Furthermore, the
clinical and histologic results of these series are consistent with those of previously published
series of patients with similar lesions treated by arthroscopic autologous chondrocyte implantation,
considered the gold standard treatment for this type of lesion. The limited number of follow-up
biopsy specimens also may be considered a limitation of the study. Nevertheless, biopsy morbidity
in an asymptomatic patient is to be considered and evaluation by alternative methods such as
qualitative MRI T2 mapping is in progress. Transplantation of the entire bone marrow cellular
pool by transferring the entire regenerative potential present in the bone marrow to the
lesion site permits the cells to be processed directly in the operating room without the need
for a laboratory phase and thus allows the technique to be performed in one step. Bone
marrow-derived cell transplantation resulted in ICRS and AOFAS scores similar to those
reported for other widely used techniques.
PRELIMINARY CONCLUSIONS: resurfacing by MSCs Normal post-op without serious
adverse events correlated to the graft
•
6/28 cases of increased temperature (<39°) completely ceased within 7 days
•
clinical sympthoms (pain, effusion, catching, giving-way) significantly decreased
within the 2nd month, and completely ceased, in all cases, within 3 months WITH
GOOD/EXCELLENT JOINT FUNCTIONAL RECOVERY
•
Significative improvement of ROM (flex-ext >15%):
average pre-op. active ROM 120° (range 80° - 140°)
average post-op active ROM 135° (range 110° - 140°)
SATISFACTORY CLINICAL RESULTS at 14 ms. average f. up
PRELIMINARY CONCLUSIONS: Significantly improved appearance of the tissue
Total scaffold biodegradation
Complete and uniform fibrocartilagineous tissue resurfacing
discrete mechanical resistence to probe palpation
Areas of uneven cartilage stiffness
The main parameter that influenced the functional score was the area of the lesionNeed to
verify the results at 3 and 5 years to appreciate the
quality of the reconstructed tissue
and the
Maintainance/IMPROVEMENT
of the (FIBRO)cartilage quality
(no degenerative changes?)
16
Although longer followup is needed to confirm the validity of the repair overtime, the
arthroscopic one-step technique represents an advance in osteochondral regeneration,
achieving high clinical scores with the formation of repair tissue and without the major
disadvantages of previous techniques.
MSCs at short term follow-up for simple Shouldered cartilage defect </= 2.5/3 cm2
demostrated Good functional/clinical results with good % of hyaline tissue
14 yrs f.up ACT in cartilage defect> 3cm2
Simple wide, Shouldered Complex-salvage to delay implant arthroplasty showed Good
functional/clinical results with good % of hyaline tissue at 14 yrs f.up
fttfg
The in vitro experiment reported in this study confirmed bone marrow-derived cells are able to differentiate into
chondral and osseous lineages, thus supporting the hypothesis that in vivo bone marrow derived cells may be
17
able to fill the whole thickness of a defect and secrete some trophic molecules, which contribute o regeneration
of damaged tissue, the final result being cartilage on the top and bone on the bottom. (Giannini, 2009).
Transplantation of the entire bone marrow cellular pool by transferring the entire regenerative potential present
in the bone marrow to the lesion site permits the cells to be processed directly in the operating room without the
need for a laboratory phase and thus allows the technique to be performed in one step. Moreover, the use of a
concentrator device produces bone marrow-derived cells with similar or greater functional activity, similar
colony-forming capacity, and a superior migratory activity compared with the more traditional product obtained
using Ficoll isolation. Bone marrow-derived cell transplantation resulted in ICRS and AOFAS scores similar to
those reported for other widely used techniques.
PRELIMINARY CONCLUSIONS: resurfacing by MSCs Normal post-op without serious adverse events correlated
to the graft
•
6/28 cases of increased temperature (<39°) completely ceased within 7 days
•
clinical sympthoms (pain, effusion, catching, giving-way) significantly decreased within the 2nd month,
and completely ceased, in all cases, within 3 months WITH GOOD/EXCELLENT JOINT FUNCTIONAL
RECOVERY
•
Significative improvement of ROM (flex-ext >15%):
average pre-op. active ROM 120° (range 80° - 140°)
average post-op active ROM 135° (range 110° - 140°)
SATISFACTORY CLINICAL RESULTS at 14 ms. average f. up
PRELIMINARY CONCLUSIONS: Significantly improved appearance of the tissue
Total scaffold biodegradation
Complete and uniform fibrocartilagineous tissue resurfacing
discrete mechanical resistence to probe palpation
Areas of uneven cartilage stiffness
The main parameter that influenced the functional score was the area of the lesionNeed to verify the results at 3
and 5 years to appreciate the
quality of the reconstructed tissue
and the
Maintainance/IMPROVEMENT
of the (FIBRO)cartilage quality
(no degenerative changes?)
Although longer followup is needed to confirm the validity of the repair overtime, the arthroscopic one-step
technique represents an advance in osteochondral regeneration, achieving high clinical scores with the
formation of repair tissue and without the major disadvantages of previous techniques.
MSCs at short term follow-up for simple Shouldered cartilage defect </= 2 cm2 demostrated Good
functional/clinical results with good % of hyaline tissue
14 yrs f.up ACT in cartilage defect> 2cm2
Simple wide, Shouldered Complex-salvage to delay implant arthroplasty showed Good functional/clinical
results with good % of hyaline tissue at 14 yrs f.up
18
ACT VS. MSCs
The aims of this study are to describe evolution in cartilage repair from open field
autologous chondrocyte implantation to regeneration by arthroscopic bone-marrow-derived
cells (BMDCs) ‘‘one step’’ technique; to present the results of a series of patients
consecutively treated and to compare in detail the different techniques used in order to
establish the advantages obtained with the evolution in cartilage regenerative methods.
81 patients (mean age 30 _ 8 years) were evaluated in this study. Patient assessment
included clinical AOFAS score, X-rays and MRI preoperatively and at different established
follow-ups. All the lesions were >1.5 cm2 and received open autologous chondrocyte
implantation (10 cases), arthroscopic autologous chondrocyte implantation (46 cases), and
‘‘one step’’ arthroscopic repair by BMDC transplantation (25 cases).
For arthroscopic repair techniques a hyaluronic acid membrane was used to support cells
and specifically designed instrumentation was developed. Patients of all the three groups
underwent a second arthroscopy with a bioptic cartilage harvest at 1 year follow-up.
Mean AOFAS score before surgery was 57.1 _ 17.2 and 92.6 _ 10.5 (P < 0.0005) at mean
59.5 _ 26.5 months. A similar pattern of AOFAS improvement in results was found in the
three different techniques.
Histological evaluations highlighted collagen type II and proteoglycan expression.
The cartilage repair techniques described were able to provide a repair tissue which
closely approximates the characteristics of the naive hyaline cartilage. Evolution in surgical
technique, new biomaterials and more recently the use of BMDCs permitted a marked
reduction in procedure morbidity and costs up to a ‘‘one step’’ technique able to overcome
all the drawbacks of previous repair techniques
19
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