Single-plug Autologous Osteochondral Transplantation

n Feature Article
Single-plug Autologous Osteochondral
Transplantation: Results at Minimum
16 Years’ Follow-up
Giuseppe Filardo, MD, PhD; Elizaveta Kon, MD; Berardo Di Matteo, MD; Alessandro Di Martino, MD;
Maurilio Marcacci, MD
abstract
Full article available online at Healio.com/Orthopedics
Different techniques have been proposed for the treatment of cartilage defects. Among the
currently available options, autologous single-plug osteochondral transplantation is one of
the few to be applied to address small and medium lesions. The goal of the current study was
to document the long-term clinical outcome of a cohort of patients treated by this surgical
strategy, which consists of harvesting a single osteochondral plug from a less weight bearing
area of the knee and implanting it on the defect site by press-fit technique. Fifteen patients
were enrolled. Age at surgery was 30.2±15.3 years, and body mass index was 22.5±3.0 kg/
m2. The inclusion criteria were clinical symptoms, such as knee pain or swelling, and grade
III to IV chondral and osteochondral knee lesions. Patients were prospectively evaluated up
to a mean of 17.5±3.5 years of follow-up by using Lysholm, International Knee Documentation Committee (IKDC) subjective, and Tegner scores. A significant improvement was noted
in all clinical scores. In particular, the IKDC subjective score increased from 34.5±23.6 to
66.3±26.4 (P=.001). The Lysholm score showed a similar trend. From a baseline value of
47.8±29.5, the score increased to 79.8±24.6 at the last evaluation (P=.001). A significant
increase in Tegner score was observed at the 2-year evaluation, with stable results up to the
last follow-up. Four failures were reported, which in 3 cases occurred at mid- to long-term
follow-up, confirming that this technique can be considered a suitable option for the treatment of small and medium chondral and osteochondral lesions in young patients.
The authors are from the Nano-Biotechnology Laboratory (GF, EK) and the Biomechanics Laboratory (BD, AD, MM), II Orthopaedic Clinic, Rizzoli Orthopaedic Institute, Bologna, Italy.
Drs Di Matteo and Di Martino have no relevant financial relationships to disclose. Dr Filardo is a
consultant for and receives institutional support from Fin-Ceramica Faenza SpA (Italy), Fidia Farmaceutici SpA (Italy), and CartiHeal Ltd (Israel); is a consultant for EON Medica SRL (Italy); and receives
institutional support from IGEA Clinical Biophysics (Italy), BIOMET (USA), and Kensey Nash (USA).
Dr Kon is a consultant for CartiHeal Ltd (Israel); holds stock in CartiHeal Ltd (Israel); and received
payment for presentations from Fin-Ceramica Faenza SpA (Italy) and Fidia Farmaceutici SpA (Italy). Dr
Marcacci receives royalties and research institutional support from Fin-Ceramica Faenza SpA (Italy).
The authors thank Federica Balboni, Luca Andriolo, Francesco Perdisa, Francesco Tentoni, Giulia
Venieri, Letizia Merli, Elettra Pignotti, and Keith Smith (Rizzoli Orthopaedic Institute, Bologna, Italy)
for their support in preparing this manuscript.
Correspondence should be addressed to: Berardo Di Matteo, MD, Biomechanics Laboratory,
II Orthopaedic Clinic, Rizzoli Orthopaedic Institute, Via di Barbiano 1/10, 40136 Bologna, Italy
([email protected]).
Received: October 3, 2013; Accepted: January 30, 2014; Posted: September 9, 2014.
doi: 10.3928/01477447-20140825-51
SEPTEMBER 2014 | Volume 37 • Number 9
e761
n Feature Article
C
artilage is one of the most challenging tissues to treat because of
its limited healing potential.1 This
is a consequence of peculiar morphologic
and functional features that up to now
have been impossible to restore. The increasing incidence of cartilage lesions and
the huge interest in this particular field of
musculoskeletal medicine led to the development of several strategies, both reparative and regenerative,2 whose clinical
results, in most cases, have been widely
reported up to mid- and long-term evaluation.3-6 Cartilage surgery is no longer in
its infancy, but the scientific community
is still debating intensely about the best
treatments for chondral and osteochondral
lesions. Different techniques have been
proposed for the treatment of the same
kind of defect, but there is no agreement
on which approach is preferable according to patient and lesion characteristics.7
Furthermore, indications vary widely
because some authors restrict cartilage
treatment to focal traumatic lesions,8
whereas others suggest that if concurrent
comorbidities, such as instability, meniscal pathology, and axial misalignment, are
addressed, even “complex” knee lesions
can benefit from cartilage treatment.9-12
To shed light on this controversial field,
it is important to assess the long-term efficacy of the procedures proposed because
patients who undergo cartilage treatment
are often young and active. Therefore, the
“ideal” treatment should provide clinical
benefit as long as possible.
Based on the current evidence, several
surgical strategies have been investigated,
ranging from classic microfracturing3 to
the most recent cell-based therapies or
cell-free approaches based on “smart”
biomimetic scaffolds.13-15 Each technique
has advantages and limits. Therefore, surgeons should evaluate every option before
deciding how to proceed. Treatments such
as mosaicplasty, autologous or allogeneic
osteochondral transplantation, autologous
chondrocyte implantation, matrix-assisted
autologous chondrocyte transplantation,
e762
and osteochondral scaffolds can be considered as possible treatments for cartilage pathology.2 However, in the case of
regenerative solutions, such as autologous
chondrocyte transplantation or biomaterials, the higher cost and regulatory limitations must be considered. Expensive and
high-tech procedures are often available
only in highly specialized centers and
are not an option for many orthopedic
surgeons. Therefore, besides the fashionable and ambitious new regenerative
treatments, there is still space for less expensive and easily available treatments to
address the damaged osteochondral unit.
Among these, mosaicplasty and singleplug autologous osteochondral transplantation are still viable solutions.
These approaches present some analogies in terms of both treatment rationale
and technical aspects. Both procedures
consist of harvesting autologous osteochondral grafts from a healthy region of
the knee to be placed in the defect site.
Looking at mosaicplasty, the arthroscopic
approach and the possibility of harvesting
multiple small cylinder-shaped autografts
from different articular sites make this
technique less invasive and contribute to
less donor site morbidity, which in theory
should allow for the treatment of larger
lesions. Conversely, some studies have
shown that the number of plugs used to
cover the defect area correlates with poorer clinical outcomes,16 probably because
it is technically very challenging to reconstruct the physiologic convexity of the
condylar cartilaginous surface with plugs
harvested from different joint sites. In addition, the cylindrical shape of the grafts
does not allow optimal coverage of the lesion site, leaving residual small uncovered
areas that might impair or diminish the
healing process. The particular technique
of single-plug autologous osteochondral
transplantation described in this study allows nearly perfect filling of the defect,
thus promoting better stability and better
bone-to-bone and cartilage-to-cartilage
healing, but it also presents greater inva-
siveness.17 This approach requires arthrotomic exposure and may cause greater
donor site morbidity than mosaicplasty
because of the size of the plug harvested,
which might become symptomatic despite being located in a less weight bearing zone.
Thus, both approaches have advantages and disadvantages, but whereas several
studies have reported long-term clinical
evaluation of mosaicplasty, no studies
have documented the long-term outcome
of this particular arthrotomic, single-plug
osteochondral autograft technique. Therefore, the goal of the current study was to
document the long-term clinical results of
a series of 15 patients treated with autologous osteochondral transplantation and
followed up for a mean of 17.5 years.
Materials and Methods
Patient Selection
The current study was approved by
the hospital ethics committee and internal
review board, and informed consent was
obtained from all patients.
Fifteen patients (9 men and 6 women)
were enrolled and treated. Mean age was
30.2±15.3 years, and mean body mass
index was 22.5±3.0 kg/m2. The inclusion
criteria were clinical symptoms, such as
knee pain or swelling, and grade III-IV
chondral and osteochondral lesions of
the knee. Exclusion criteria were uncorrected axial deviation and knee instability.
Axial deviation and knee instability were
evaluated clinically and via radiograph.
Patients who presented with significant
knee axial deviation (>5°) underwent
corrective osteotomy in the same surgical session as the osteochondral grafting.
Patients with infectious, neoplastic, metabolic, and inflammatory pathology were
also excluded.
Two patients were lost to follow-up, so
their data could not be included in the statistical analysis.
Lesion size ranged from 1.5 to 4.5 cm2.
Defects included 10 medial femoral condyles and 3 lateral femoral condyles. The
ORTHOPEDICS | Healio.com/Orthopedics
n Feature Article
etiology was osteochondritis dissecans in
5 cases and osteonecrosis in 6 cases. The
cause was degenerative in 1 patient and
posttraumatic in 1 case.
Before symptom onset, 3 patients practiced competitive sports (2 soccer and 1
basketball) (preinjury Tegner score, ≥7),
whereas 9 patients were amateur athletes
(preinjury Tegner score, 3-6). Only 1
patient, the one with degenerative etiology, was not involved in any sport (Tegner score, <3). Eight patients were treated
for the first time, whereas 5 patients had
undergone previous surgery, including 1
high tibial osteotomy and 4 medial meniscectomies. In 3 patients, other combined
procedures were performed during the
same operation: 1 patellar realignment
and lateral release and 2 distal femoral
osteotomies.
assisted mobilization of the knee or continuous passive motion for 6 hours daily
with 1 cycle/min was recommended until
90° of flexion was reached. Patients did
not usually require more than 2 weeks of
continuous passive motion. Early isometric and isotonic exercises and controlled
mechanical compression were performed.
Voluntary muscular contraction and electrical neuromuscular stimulation were
indicated and could be started on patient
discharge. After 45 days, weight touchdown with crutches was allowed, and the
patient could then move gradually toward
full weight bearing, usually at 8 weeks.
Active functional training was then started, with the goal of returning to a correct
running pathway by proprioceptive muscular strengthening, endurance exercises,
and aerobic training.
Surgical Procedure
Surgery was performed with an arthrotomic approach. After exposure of the
articular surface, the osteochondral defect
was identified and all fibrous tissue was
excised down to a base of cancellous bone.
The depth of the graft site and the amount
of bone resected were as large as necessary to reach bleeding bone on all sides
of the defect. The osteochondral graft was
removed from the donor zone on the superior aspect of the lateral femoral condyle,
preserving the patellar groove. The graft
bone was carefully contoured so that it
fit precisely into the recipient bed. Graft
thickness was equal to the recipient site
depth so that the graft cartilage surface did
not sit either above or below the articular
cartilage level of the femoral condyle. In
most cases, sufficient graft stability was
achieved with press-fit fixation, whereas
in a few cases, screw fixation was used.
Then drainage was placed, and the wound
was closed in layers.
Postoperative management focused
on early mobilization to facilitate faster
resolution of swelling, promote healing
and joint nutrition, and prevent adhesions.
On the second postoperative day, self-
Patient Evaluation
Patients were prospectively followed
for a mean of 17.5±3.5 years (range, 1624 years). Clinical outcomes of all patients
were analyzed using the Lysholm score
and the International Knee Documentation Committee (IKDC) subjective score.
Returning to participation in sports was
also evaluated using the Tegner score and
compared with preoperative and preinjury
levels. Adverse events and failures were
also recorded. Failure was defined as the
need for reintervention because of symptoms related to the primary osteochondral
defect. In the case of unsuccessful treatment, the last scores before reintervention
were reported for analysis at subsequent
follow-up.
SEPTEMBER 2014 | Volume 37 • Number 9
Statistical Analysis
All continuous data were expressed as
mean and standard deviation; categorical
variables were expressed as frequency
and percentages. The Wilcoxon nonparametric test was used to test the differences
at different follow-up times. The MannWhitney nonparametric test was performed to assess between-group differences of continuous data. The Spearman
rank correlation was used to assess correlation between rank and continuous data,
and the Kendall tau ordinal correlation was
used to assess correlation of ordinal data.
Fisher’s chi-square test was performed to
investigate the relationships between dichotomous variables. Pearson’s chi-square
test evaluated by exact methods for small
samples was performed to investigate the
relationships between grouping variables.
All nonparametric tests were evaluated by
exact methods for small samples. KaplanMeier survival analysis was performed to
assess overall survival, the log-rank test
was used to investigate the influence of
categorical variables on survival, and Cox
regression analysis was used to investigate the influence of continuous variables
on survival. For all tests, P<.05 was considered significant. All statistical analysis
was performed with SPSS, version 19.0
(IBM, Armonk, New York).
Results
No severe adverse events were reported in the current series.
Significant improvement was found
in all clinical scores. In particular, the
IKDC subjective score increased from
34.5±23.6 at baseline to 66.3±26.4 at
final follow-up (P=.001; Figure 1). The
Lysholm score showed a similar significant trend. From a baseline value
of 47.8±29.5, the score increased to
79.8±24.6 at the last evaluation (P=.001;
Figure 2). A significant increase occurred
in the Tegner score at the 2-year evaluation, and the score remained stable up to
the last evaluation (Figure 3). In fact, the
mean sport activity level increased from
2.46±2.1 (preoperative level) to 3.9±2.5
at the 2-year evaluation (P=.006), which
was confirmed (4.1±2.6) at the last follow-up (not significant). Despite this
positive trend, the majority of patients
were not able to regain the same preinjury sport activity level, as shown by
the significant difference remaining between preinjury and final Tegner scores
(5.6±2.3 vs 4.1±2.6; P=.016).
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Figure 1: International Knee Documentation Committee subjective score improvement from preoperatively to a mean of 17.5 years of follow-up.
Figure 3: Tegner score improvement: evaluation at preinjury (pre-inj), pretreatment (pre-op), 2-year follow-up, and final long-term follow-up.
The current series had 4 treatment
failures (Figure 4). In the first case, no
clinical improvement was obtained. The
patient sought other treatment at a different medical center and was not available for further interview by the current
authors. The second patient was treated
again 13 years after the osteochondral
autograft and underwent implantation of
a biomimetic 3-layered osteochondral
scaffold on the medial femoral condyle.
The operation was performed in the authors’ division, and after 3 years, the
clinical condition was satisfactory and
the patient reported improvement in pain
e764
Figure 2: Lysholm score improvement from preoperatively to a mean of 17.5
years of follow-up.
Figure 4: Cumulative survival rate up to the maximum follow-up evaluation of
the current study (24 years postoperatively).
and knee function. The third patient was
treated after 14 years by total knee arthroplasty because of the development
of diffuse osteoarthritis. The last patient
was treated again 8 years after osteochondral autograft transplantation at another
medical center by microfracturing in the
same area. Because the patient could not
be contacted for an interview, no data are
available on the clinical outcome.
Because of the low number of patients
included in the current study, no statistical
correlation could be found among clinical
outcomes and parameters that might influence the results, such as etiology, previ-
ous surgeries, combined surgeries, sex, or
body mass index.
Discussion
The main finding of the current study
was that single-plug autologous osteochondral transplantation can provide a
good clinical outcome and improvement
in knee functional status, with stable results at very long-term evaluation.
The treatment of cartilage pathology is a topic of intense preclinical and
clinical research, and mid- and long-term
outcomes of some procedures, both reparative and regenerative, have been de-
ORTHOPEDICS | Healio.com/Orthopedics
n Feature Article
scribed. For the regenerative approach,
several cell-based or scaffold-based procedures have been proposed, but they are
all limited by high cost and regulatory
limitations. Despite the goal of restoring
an optimal articular surface, no treatment
has clearly proven to regenerate hyaline
tissue or clearly exceed the results obtained with less expensive and widely
available traditional procedures.15,16,18
The classic reparative approach is bone
marrow stimulation. Despite being developed decades ago, this technique is
still widely applied. In 2003, Steadman
et al3 published their results in a cohort
of 72 patients treated with microfractures
and evaluated at a mean of 11 years of
follow-up. Clinical outcome was satisfactory, and the authors reported superior results for patients younger than 35 years.
The same trend was shown by Kreuz et
al,19 who noticed that patients older than
40 years with patellofemoral lesions had
poorer clinical results. Besides the commonly reported good short-term results,
more controversial is the long-term outcome, with evidence of progressive worsening over time.20 Mosaicplasty offered
a good clinical outcome. Hangody et al21
reported the clinical outcome of the largest series (831 patients), with 92% good
to excellent results for femoral condyle
defects at short-term follow-up, confirmed in a further evaluation at a mean
of 9 years (although the follow-up interval was rather inhomogeneous, ranging
from 2 to 17 years). Other reports confirmed good results at mid- to long-term
follow-up.22-24 However, after reporting
marked early improvement, Solheim et
al25 observed significant clinical deterioration between 5 and 9 years of followup. In a further evaluation 10 to 14 years
after surgery,26 they observed a general
poor outcome in 40% of the 73 patients
treated, but noted good results in younger
men with small lesions. The indication
for treatment is probably the key to explaining these heterogeneous results. For
example, Ollat et al27 reported significant
SEPTEMBER 2014 | Volume 37 • Number 9
clinical improvement, with an 82% satisfaction rate, in a large cohort of patients
at 8 years of follow-up, especially in men
with small lesions, osteochondritis dissecans, a medial femoral condyle site, and
short preoperative duration of symptoms.
Marcacci et al16 confirmed that this technique can offer good clinical and imaging
results,28 but only in small lesions that require a limited number of plugs.
In contrast to the abundant literature on
mosaicplasty, only a few studies have reported different kinds of single-plug techniques, such as the one used in the current
study. Outerbridge et al29 harvested a single
autograft from the lateral facet of the patella to minimize donor site morbidity. A
satisfactory clinical outcome was obtained
in each of the 10 patients evaluated at a
mean of 6.5 years of follow-up, but mild
anterior knee pain occurred in 4 cases,
flexion limitation in 2, and the formation
of small osteophytes in the donor area in
5 cases. These osteophytes were associated
with anterior pain in 3 cases and mild patellar tilt in 2 cases. Marcacci17 et al reported
mid-term results after using an autologous
osteochondral plug, harvested from the
superior part of the lateral condyle, to fill
femoral condyle defects. They reported
that 12 of 13 patients had a good clinical
outcome and returned to their preinjury
level of activity at a mean of 61.5 months,
and radiographs showed good integration
of the plug. The procedure has also been
tested for large osteochondral condylar defects. Agneskirchner et al30 treated 29 patients with a mean defect size of 7.2 cm2 by
harvesting a single graft from the posterior
femoral condyle, which was then fixed either by a screw or by press-fit. Twenty-six
patients had reduced pain and swelling at a
mean of 17.7 months, and 3 were not satisfied, whereas magnetic resonance imaging showed good viability of the graft. No
complications related to the graft were reported at this short follow-up time, and the
authors pointed out the advantages of using a single graft for better rendering joint
congruence.
The single-plug approach offers the
opportunity to fill the lesion site perfectly
with a graft sized to match the ostechondral defect, thus allowing optimal boneto-bone and cartilage-to-cartilage healing. However, there is a risk of donor site
morbidity, especially considering the size
of the graft, which cannot be neglected.
Some studies specifically focused on this
aspect and tried to prove and quantify the
risk of morbidity. LaPrade and Botker31
documented 2 patients who required shaving of fibrous hypertrophy or filling with
fresh osteochondral allograft to address
persistent knee pain after osteochondral
plug harvesting. Valderrabano et al32 used
the knee as a donor joint to treat ankle
joint defects and observed a significant
increase in the mean visual analog scale
score of the harvested knee in 6 cases
(50%). The pain was completely resolved
in 5 of 6 patients at 1 year of follow-up.
Cartilage changes, joint space narrowing, and cyst formation were detected in
all except 1 knee on magnetic resonance
imaging, and focal radioisotope uptake
was abnormal on single-photon emission
computed tomography in 7 of 12 knees.
However, no correlation was found with
clinical outcome. Paul et al33 reported 112
patients (of 200) with asymptomatic donor knees before the procedure who had
a marked reduction in the Lysholm score
at short-term follow-up, followed by a
progressive increase over time to midterm follow-up. Neither the total area of
harvest nor the number of plugs had any
influence, whereas higher body mass index negatively influenced the outcome.
Finally, Reddy et al34 reported that 9 of 11
patients had a decreased Lysholm score
in previously asymptomatic donor knees
at 28 to 77 months of follow-up after
knee-to-talus osteochondral grafting. No
correlation was found with respect to the
harvest technique, either arthrotomy or arthroscopy, or the number of grafts used. In
light of these remarks, donor site morbidity is an important factor that might affect
the overall outcome of the procedure, thus
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jeopardizing joint homeostasis and results
over time.
The current study evaluated the results
obtained after an autologous transplantation procedure at very long-term followup. Despite the invasiveness of the arthrotomic approach35 and the size of the
osteochondral plug harvested, this study
showed that this technique can provide
clinically significant improvement and a
stable outcome over time.
This finding is important because patients undergoing cartilage procedures are
often young and demanding, and therapeutic options should provide long-lasting
beneficial effects to avoid the need for early reintervention with more invasive procedures. Furthermore, the need to reduce
costs and the different reimbursement policies applied in different countries make
cartilage procedures a “keep-an-eye-on”
treatment because modern cell-based and
biomaterials-oriented technologies are
not always available or feasible.36 The
strength of osteochondral grafting is also
obvious from this point of view. Despite
being less modern or innovative, there is
still space for its application in clinical
practice. Therefore, it is important to report indications, limits, and results over
time.
However, the current study has some
limitations, which are the small number of
patients treated (which did not allow for
subanalysis to determine the correlation
between size and outcome and to identify
a size threshold to avoid donor site morbidity), the lack of a control group, and
lack of imaging evaluation. Despite these
limitations, to the authors’ knowledge,
this is the first trial to report clinical data
on this particular technique at long-term
follow-up, showing overall good clinical
results. The very long-term mean 17 years
of follow-up allowed documentation of
both stable general clinical improvement
and failure over time. All treatment failures except 1 occurred at mid- to longterm evaluation. Therefore, most of the
patients who failed actually benefited
e766
from this procedure for several years. This
technique can be considered as a suitable
treatment option for small and medium
chondral and osteochondral knee lesions.
However, larger studies are needed to better identify patients who may benefit from
this procedure, in particular, in terms of
size-related risk of donor site morbidity.
Conclusion
Single-plug autologous osteochondral transplantation is a safe, 1-step, and
cost-effective procedure for the treatment
of small and medium chondral and osteochondral lesions. This technique provided
overall good results, even over the long
term. Direct transplantation of a viable autologous osteochondral unit did not avoid
failure over time in a considerable number of cases. However, even if treatment
was unsuccessful in some of the patients
and further operations were needed, most
patients showed marked clinical improvement for several years.
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