Knee Surg Sports Traumatol Arthrosc
DOI 10.1007/s00167-016-4135-9
KNEE
Resorbable screw and sheath versus resorbable interference
screw and staples for ACL reconstruction: a comparison of two
tibial fixation methods
Christian Carulli1 · Fabrizio Matassi1 · Stefano Soderi1 · Luigi Sirleo1 ·
Giovanni Munz1 · Massimo Innocenti1 
Received: 24 September 2015 / Accepted: 14 April 2016
© European Society of Sports Traumatology, Knee Surgery, Arthroscopy (ESSKA) 2016
Abstract  Seven patients with the screw/staples tibial fixation needed
Purpose  The anterior cruciate ligament (ACL) recon-
struction is one of the most performed and successful ortho-
paedic procedures. The results are considered independent
by the choice of the graft and the fixation devices. A grow-
ing interest on resorbable non-metallic fixation devices ver-
sus standard metallic fixation devices has been noted over
recent years with few clinical experiences reported in the
literature. The aim of this study is to compare the clinical
and radiological outcomes of patients undergoing ACL
reconstruction using autologous hamstring tendons with
tibial fixation by a centrally placed resorbable screw and
sheath to a combination of an eccentrically placed resorb-
able interference screw and supplementary staple fixation.
Methods  Ninety patients undergoing an isolated, sin-
gle-bundle, primary ACL reconstruction with autologous
hamstring tendons, using the same femoral fixation, were
randomized to a tibial fixation with a centrally placed
resorbable screw and sheath, BioIntrafix (group A), or an
eccentrically placed resorbable interference screw, BioRCI,
and two non-resorbable staples (group B). The latter has
represented for many years our standard fixation method.
Clinical evaluations (KOOS, IKDC, KT-2000™ side-to-
side difference) and radiological analyses were conducted
in both groups with a minimum follow-up of 2 years.
Results  We assisted in a satisfactory pain relief and func-
tional improvements, without significant clinical and radio-
logical differences in both groups. No further surgery was
needed in patients with the screw/sheath tibial fixation.
* Christian Carulli
christian.carulli@unifi.it
1
Orthopaedic Clinic, University of Florence, Largo P. Palagi
1, 50139 Florence, Italy
the surgical removal of the fixation devices due to pes
anserinus irritation or local infection years after the index
operation. Other parameters such as the tunnel enlargement
were not statistically different in the two groups.
Conclusions  Good clinical and radiological outcomes of
ACL reconstruction by a screw/sheath tibial fixation have
been reported showing comparable results with respect to
screw/staples fixation. There were no failures associated
with loss of fixation with either of tibial fixation meth-
ods. A fewer number of surgical removals of tibial devices
were also recorded in patients treated by the screw/sheath
fixation system, related to the absence of local intolerance
or infection compared to subjects with a standard tibial
fixation.
Keywords  ACL · ACL reconstruction · Resorbable
fixation devices · BioIntrafix · BioRCI · Staple ·
Tunnel enlargement
Introduction
The anterior cruciate ligament (ACL) reconstruction is one
of the most performed and successful orthopaedic pro-
cedures, showing a good reproducibility and high rates
of clinical improvements [8, 12, 29]. These outcomes are
independent by the choice of the graft and the type of fixa-
tion. The use of autologous hamstring tendons for ACL
reconstruction has increased in popularity over the recent
years [1]. Hamstring tendons have shown a decreased
donor-site morbidity, less anterior knee pain, and no exten-
sor mechanism alterations with a similar mechanical
behaviour compared to bone–patellar tendon–bone grafts
[6, 37, 44, 45]. Concerns on the stability of graft fixation on
13
 Knee Surg Sports Traumatol Arthrosc

the tibial side remain [1]. The tibial fixation is commonly fractures of the femur or tibia, subjects with open physes,
considered more problematic than femoral fixation because severe chondral lesions needing microfractures or chondro-
all forces on the ACL substitute are parallel to the tibial cytes transplantation and previous surgery on the same joint.
tunnel [3, 32], the tibial metaphysis is weaker compared to Patient characteristics are reported in Table 1.
the femur [4, 10, 32], and the tail end of the graft is more
difficult to be secured on the tibial side. Fixation devices Surgical technique
must be able to withstand early post-operative forces until
graft-to-tunnel healing that usually occurs about 12 weeks All patients underwent an ACL reconstruction by the same
after surgery [19]. By the use of hamstrings, the tibial fixa- surgical technique performed by the two senior surgeons
tion has been considered the weakest point of the procedure (MI and CC): three arthroscopic portals, one mini-incision
[14]. A growing interest on resorbable non-metallic fixa- for hamstring tendons harvesting, transtibial position-
tion devices versus standard metallic fixation devices has ing, single bundle and duplicated autologous hamstrings.
been noted over recent years [1, 9, 18, 24, 40]. To date, sev- A pneumatic tourniquet was applied around the upper
eral in vitro studies have been conducted trying to assess thigh and inflated to 250 mmHg in all cases. The knee
the biomechanical advantage of a fixation device over the was placed at 90° of flexion and surgery started with an
others. Interesting results have been obtained regarding arthroscopic examination through conventional anterolat-
soft devices compared to metallic screws, pins and wash- eral (AL) and anteromedial (AM) portals. After the ini-
ers. Recent studies have demonstrated a better behaviour of tial assessment and joint debridement, hamstrings were
resorbable non-metallic systems regarding the load peak, then harvested from the affected limb. The aimer of the
insertion torque and pull-out strength [9, 24, 40], while tibial director drill guide set on 50°–55° was introduced
other showed comparable results [1, 5, 7, 15, 20, 46]. On through the AM portal and the tip of the guide placed to
the other hand, the incidence of tunnel enlargements with the centre of the ACL tibial footprint. The extra-articular
resorbable devices has been shown to be higher than with landmark of the tibial tunnel was 1 cm above the inser-
metallic devices [2, 11, 13, 16, 17, 22, 28, 33, 34, 36]. tion of the pes anserinus and 1.5 cm medial to the tibial
However, while in vitro demonstrations of the efficacy of tubercle. After the guidewire was inserted, a tibial tunnel
resorbable devices have been widely reported, clinical stud- was created using a cannulated drill bit matching the graft
ies on the effective outcomes are still lacking. Thus, the aim diameter. A 3- to 4-mm offset hook of the femoral drill
of this study is to assess the clinical and radiological out- guide was positioned at the over-the-top position, in direct
comes of ACL reconstructions using autologous hamstring contact with the bony cortex. The offset guide was then
tendons with tibial fixation by a centrally placed resorbable laterally rotated in order to put the drill guide as close as
screw and sheath compared to a combination of an eccen- possible to the centre of the ACL footprint. An appropri-
trically placed resorbable interference screw and supple- ated cannulated drill bit was then passed through the tibial
mentary staple fixation in a series of patients affected by
acute ACL lesions.
Table 1  Demographic data of the study groups
A B p value
Materials and methods [BioIntrafix®] [BioRCI®+Ti
(n = 45) Staples]
(n = 45)
A prospective study was conducted to compare the two tib-
ial fixation methods. Between 2009 and 2012, ninety con- Group
secutive patients undergoing a primary ACL reconstruction Age (years) 31.0 (16–42) 31.8 (18–44) n.s.c
were randomly selected for one of the two tibial fixation Gendera n.s.c
methods.  Male 36 (80 %) 33 (73.3 %)
 Female 9 (20 %) 12 (26.7 %)
Patient selection Body mass index 21.9 (19.5–23.8) 20.2 (18.6–25.1) n.s.b
(BMI)
Only patients with unilateral isolated ACL ruptures, who Injury/surgery delay 50.2 (32–98) 57.1 (30–107) n.s.b
(days)
were candidates for an arthroscopically assisted reconstruc-
tion, were included in the study in order to avoid any bias. Values are expressed as median (range) unless otherwise specified
Exclusion criteria were: additional knee ligament injuries a
  Values are expressed as the number of patients and (percentage)
(posterior cruciate ligament, posterolateral and posterome- b
 Student’s t test
dial knee complex injuries, medial and lateral collateral liga- c
  Fisher’s exact Chi-squared test
ment injuries, medial and lateral meniscus tears), associated

13
Knee Surg Sports Traumatol Arthrosc
tunnel and over the guidewire to create a femoral tunnel of
30 mm depth. Autologous hamstring graft was then passed
through the tibia into the joint and through the femoral
socket, and fixed on the femoral side. In all cases, the same
femoral fixation method was adopted (EndoButton® CL,
Smith & Nephew, Memphis, TN) with a variable length of
15–35 mm. The graft was fixed on the tibial side by two
different fixation devices. Patients were randomly assigned
to one of the study groups in a 1:1 ratio using opaque
sealed envelopes. Each envelope contained a description of
the tibial fixation method.
Group A (screw/sheath) patients received a tibial fixa-
tion with BioIntrafix® (DePuy-Mitek, Raynham, MA,
USA), characterized by a combination of a centrally placed
resorbable polylactic acid/tricalcium phosphate (PLA/TCP)
screw (diameter 6–10 mm; length 30 mm) and a resorb-
able PLA/TCP sheath (diameter 7–9 mm; length 30 mm)
(Fig.  1a). The advancement of the screw into the expand-
ing sheath concentrically compresses the four strands of the
graft against the wall of the bone tunnel. The tibial fixa-
tion was performed with the knee at 30° flexion and apply-
ing a 30–35 N tension to the graft using the dedicated tie
tensioner.
Group B (screw/staples) consisted in a fixation of the
tibial side by a combination of BioRCI® (Smith & Nephew,
Memphis, TN), an eccentrically placed resorbable PLA
interference screw (diameter 7–9 mm; length 30 mm), and
two titanium (Ti) staples (Citieffe, Bologna, Italy) with a
width of 8 mm and length of 25 mm (Fig. 1b). Interference
screw and staples eccentrically compress the graft against
the wall of the tibial bone tunnel and the outer surface of
the tibial cortex, respectively. The tibial fixation was per-
formed with the knee at 30° flexion and by applying a
manual tension. This type of fixation represented for many
years our standard fixation method.
Fig.  1  a BioIntrafix® (DePuy-Mitek®) resorbable screw with sheath.
b Titanium staple (Citieffe®) and BioRCI® (Smith and Nephew®)
resorbable interference screw
Rehabilitation protocol
The same rehabilitative protocol was proposed in both
groups, consisting in the use of a range of motion (ROM)
brace with limited flexion and no weightbearing for the first
two weeks; controlled ROM exercises after 2 weeks; free
ROM after 3–4 weeks; progressive muscle strengthening
programme after 4 weeks. The return to the specific sport
or professional activity was suggested after 5–6 months.
Radiographic evaluation
Antero-posterior (AP) and the lateral (LL) digital plain
radiographs were analysed to verify the tibial tunnel
enlargement. Tunnel widening was measured according to
the criteria of L’Insalata et al. [28]. All measurements were
performed by two other independent and blinded surgeons
(SS, LS) not participating in the surgical procedures. Tibial
bone tunnels were measured in the AP and LL views. Thin
sclerotic lines indicating the diameter of the bone tunnel
were used for the determination of the size. Specifically,
all measurements (corrected for magnification) were per-
formed perpendicular to the long axis of the tibial tunnel
in the middle of the tunnel on the immediate post-operative
radiographs and at the last follow-up visit (24 months after
surgery). Tibial tunnel widening was expressed as a per-
centage of the diameter of the drill bit used to create the
tunnel. The diameter was measured using a digital radio-
logical software provided by the Radiology Unit PACS®
(General Electric Healthcare, Little Chalfont, GB-BKM,
England) (Fig. 2). The intraobserver and interobserver reli-
abilities in such measurements were assessed by determin-
ing the intraclass correlation coefficient (ICC). The single
measured ICC was used to determine the intraobserver reli-
ability of measurements obtained in two occasions by each
observer. The mean measured ICC was used to evaluate
the interobserver reliability by comparing the mean of two
measurements of each variable.
Clinical evaluation
Clinical follow-up evaluations were then conducted at 6,
12 and 24 months and made by two independent examiners
(FM and GM) not present at the time of surgery. The pre-
operative evaluation was conducted by the Knee injury and
Osteoarthritis Outcome Score (KOOS) [39], the Interna-
tional Knee Documentation Committee Score (IKDC) [23]
and a ligament stability assessment by KT-2000® arthrome-
ter (MEDmetric Corporation, San Diego, CA, USA). Inter-
limb ligament stability differences were calculated by sub-
tracting the laxity measurement of the uninjured knee from
the laxity measurement of the injured knee. Intraoperative
13

Fig.  2  a Radiograms at 2-year follow-up in a patient with a ACL
reconstruction with a tibial fixation by BioIntrafix® (DePuy-Mitek®).
No significant tibial tunnel widening. b Radiograms at 2-year follow-
up in a patient with a ACL reconstruction with a tibial fixation by two
titanium staples (Citieffe®) and BioRCI® screw (Smith & Nephew®).
No significant tibial tunnel widening
and postoperative complications were recorded. The post-
operative study was similarly performed.
The Institutional Review Board approved the study
and follow-up (no. AOUC/DCMT/004.11.2008), respect-
ing the criteria of the Declaration of Helsinki. All subjects
accepted the proposed treatment and follow-up after an
adequate information and written consent.
Statistical analysis
Statistical analysis was performed by SPSS software 11.0
(Inc, Chicago, IL). The amount of tibial tunnel percentage
enlargement between the groups was compared using Stu-
dent’s t test. Student’s t test and Fisher’s exact Chi-squared
test were used to compare demographic data. KT-2000
side-to-side difference, KOOS score and IKDC values were
statistically analysed using Student’s t test, Mann–Whitney
13
Knee Surg Sports Traumatol Arthrosc
U test and Fisher’s exact Chi-squared test, respectively. A p
level of 0.05 was considered significant. One-way ANOVA
tests were used to determine whether tibial tunnel enlarge-
ments had any correlation with KOOS, IKDC scores and
KT-2000 measurements.
Sample sizes were determined based on predicted power
to detect a difference of 15 % between groups with an alpha
0.05 and 80 % power. A difference of 15 % was considered
clinically relevant. Based on the formula of Lieber [31],
minimal sample size of between 32 and 36 subjects per
group was calculated from our pilot study of five patients
per group.
Results
There were no significant differences between the two
groups in age, gender, BMI and injury/surgery delay, values
of which are shown in Table 1. All patients completed the
minimum follow-up of 2 years. No intraoperative compli-
cation was recorded for the group B. A single intraoperative
complication was recorded for the group A, consisting in
an accidental rupture of the sheath of the BioIntrafix during
its positioning in the tibial tunnel: immediately removed, it
was substituted by a new one, without any further compli-
cation. Early complications were recorded in both groups:
two superficial wound infections for the group A and three
for the group B, both treated by oral antibiotics and local
advanced wound care; four cases (two for each group) of
effusion and persistent pain, managed by analgesics and
physical therapy. Late complications were also recorded
for both groups. One patient in the group A and one in
the group B referred a new ACL rupture after an acciden-
tal sprain during sport activity, respectively, after 19 and
21 months after the index operation. Seven patients in the
group B referred over the years a late infection (two cases)
or an intolerance to the two metallic staples with persistent
mild to severe pain over the pes anserinus (five cases). All
patients needed a surgical removal of all staples, with no
further complications. At the final follow-up, no patient
treated by the BioIntrafix system referred any intoler-
ance or soft/hard tissues irritation induced by the fixation
system.
Radiographic evaluation
Two years after surgery, the mean tibial tunnel enlargement
percentages were calculated and are shown in Table 2.
When comparing these values, the mean AP and LL
enlargements were 21.6 % in the group A (standard devia-
tion SD ± 5.8 %) and 22.3 % (SD ± 4.9 %), respectively,
compared to 20.2 % (SD 7.3 %) and 21.5 % (SD ± 6.3 %)
in the group B.
Knee Surg Sports Traumatol Arthrosc

Table 2  Radiological outcomes: tibial tunnel enlargement tibial tunnel enlargement, using these two different fixation
A B p value methods, was similar in groups A and B at 2 years.
[BioIntrafix®] [BioRCI®+Ti Sta- The interobserver and intraobserver reliabilities for tun-
(n = 45) ples] nel measurement on AP and LL view were satisfactory,
(n = 45) with mean ICC values of 0.86 (range 0.84–0.89) and 0.84
Group (range 0.82–0.87), respectively.
Tunnel enlargement  %
 24 months Clinical evaluation
a
  Tibial AP 21.6 ± 5.8 20.2 ± 7.3 n.s.
  Tibial LL 22.3 ± 4.9 21.5 ± 6.3 n.s.a Mean KOOS and IKDC values and KT-2000 measure-
ments values are reported in Table 3. At 2 years, the mean
Values are expressed as median ± standard deviation side-to-side difference for anterior displacement using the
a
 Student’s t test arthrometer at 134 N of traction at 30° flexion was 1.8 mm
(SD  ± 0.2 mm) in group A and 1.9 mm (SD ± 0.4 mm)
in group B. The mean KOOS score was 91 (SD ± 5.4) in
Table 3  Clinical outcomes group A and 92 (SD ± 4.8) in group B. In group A, the
A B p value
mean IKDC subjective score was 89 (SD ± 2.7); 48.9 %
[BioIntrafix®] [BioRCI®+Ti Staples] of our patients had a normal knee (IKDC A), and 51.1 %
(n = 45) (n = 45) of patients had a nearly normal knee (IKDC B). Similar
results were found in group B. The mean IKDC subjec-
Group
tive score was 92 (SD ± 1.9); 46.7 % of our patients had
KT-2000™ side-to-side difference (mm) n.s.c
a normal knee (IKDC A), and 53.3 % of our patients had a
 Baseline 6.7 ± 2.8 6.5 ± 2.4
nearly normal knee (IKDC B). Both groups had no patients
 24 months 1.8 ± 0.2 1.9 ± 0.4
at IKDC grade C or D.
KOOS score (/100) n.s.d
At the last follow-up, both groups reached a satisfac-
 Baseline 61 ± 11.8 71 ± 19.6
tory pain relief and functional improvements, without
 24 months 91 ± 5.4 92 ± 4.8
significant differences. KT-2000 side-to-side differences
IKDC subjective score (/100) n.s.e
(p  = n.s.), the KOOS scores (p  = n.s.) and IKDC sub-
 Baseline 40 ± 17.1 44 ± 15.1
jective scores and objective grade (p  = n.s.) were similar
 24 months 89 ± 2.7 92 ± 1.9
between the two types of tibial fixation. In our experience,
IKDC objective grade (n)a, b n.s.e
the amount of tibial tunnel enlargement did not affect clini-
 Baseline cal results at 2 years.
  A 0 (0.0) 0 (0.0)
  B 0 (0.0) 0 (0.0)
  C 17 (37.8) 11 (34.4) Discussion
  D 28 (62.2) 34 (65.6)
 24 months Two are the most important findings of the present study.
  A 22 (48.9) 21 (46.7) The first is the demonstration that resorbable devices for
  B 23 (51.1) 24 (53.3) tibial fixation in ACL reconstructions are effective as metal-
  C 0 (0.0) 0 (0.0) lic systems in terms of post-operative scores and functional
  D 0 (0.0) 0 (0.0) recovery. The second important result is that resorbable
Values are expressed as median ± standard deviation
devices are not associated with early or late local intoler-
a ance or infections as sometimes metallic devices do, need-
  A, normal; B, nearly normal; C, abnormal; D, severely abnormal
b ing further surgical procedures.
  Values are expressed as number of patients and (percentage)
c ACL reconstruction is a reliable and successful proce-
 Student’s t test
d dure. In our prospective study, two tibial fixation methods
 Mann–Whitney U test
e
were compared: the “modern” fixation, consisting in a cen-
  Fisher’s exact Chi-squared test
trally placed resorbable screw and sheath, and the “stand-
ard” fixation, resulting in an eccentrically placed resorbable
screw supplemented with two Ti staples. Although several
Using the independent Student’s t test, these differences studies have shown acceptable results with interference
were similar. Differences between the two groups were not screw alone, there has been some evidence to suggest that
statistically significant (p = n.s.). These values indicate that supplemental fixation is better on the tibial side when using

13

hamstrings [21, 41]. Recent interests have been focused
on the mechanical and biological properties of the modern
resorbable fixation devices [7, 15, 24–27, 42, 46]. Several
in vitro studies have shown the characteristics of resorb-
able and non-resorbable fixation devices, mainly related to
the strength of the fixation. A slight mechanical superiority
of specific soft tibial fixation devices, both resorbable and
non-resorbable, compared to conventional tibial fixation
devices has been assessed [24, 35, 40]. On the other hand,
several reports showed no differences from a clinical point
of view [15, 20], or even higher rates of complications
compared to standard fixation method [27]. Other matter
of discussion is the induction of a local bone reaction by
the fixation devices, particularly the tibial tunnel widen-
ing. Several authors have hypothesized a possible clinical
significance of the tunnel widening associated with the use
of non-metallic devices [27, 35, 36]. There are some stud-
ies and reports, which have shown an association of tibial
tunnel widening and clinical outcome. In an MRI study
of tunnel widening, Moisala et al. [34] compared bioab-
sorbable to metal screw fixations in autologous hamstring
ACL reconstruction. They reported a significant associa-
tion of tibial tunnel widening and knee laxity at 2-year fol-
low-up (p = 0.02), even if tibial tunnels showed no inter-
group differences. Laxdal et al. [30] analysed two similar
groups in their radiographic study. They observed signifi-
cant radiographically larger tibial tunnels in the resorb-
able group compared to the metal group at 2-year follow-
up (p < 0.0001); nevertheless, tibial tunnel widening did
not correlate with inferior clinical outcomes. A report of a
symptomatic knee instability due to an ACL laxity related
to the presence of a symptomatic tibial tunnel enlargement
induced by a resorbable tibial fixation device has been pub-
lished [38]. The case regarded a patient affected by mul-
tiple articular injuries (ACL, MCL and lateral meniscus
tears) undergoing multiple surgeries over the years with
one revision of the ACL reconstruction, showing that these
symptoms may not be related directly to the bone tunnel
enlargement.
The present study has some limitations. The study
groups are limited in the number of patients; however
they represent our preliminary experience with the mod-
ern screw/sheath tibial fixation method compared with
our previous standard screw/staples tibial fixation. The
follow-up is also short, but it is well known that compli-
cations (particularly a new rupture) mainly occur within
the first 2 years [20]. The study may be considered weak
for the radiological analysis. To evaluate bone tunnel wid-
ening, a digital plan radiograph was used instead of com-
puted tomography, because no significant difference was
recorded in a comparison study of these two imaging tech-
niques for tibial tunnel measurements [43]. A MRI study
could be made to compare these tibial fixation devices.
13
Knee Surg Sports Traumatol Arthrosc
However, in the daily clinical practice there was a
recently switch from our standard metallic tibial fixation to
a modern resorbable device, to prevent late complications
as pes anserinus irritations or local infections, needing a
further surgical procedure.
Conclusions
This study is one of the few reports showing the outcomes
of ACL reconstruction by a widely used screw/sheath tibial
fixation device, demonstrating a non-inferiority compared
to standard tibial fixation devices. More specific and con-
sistent trials have to be planned to assess the actual utility
of these modern fixation devices, also analysing their costs
compared to the standard fixation.
Acknowledgments  The authors wish to thank Marco Biondi,MD
and Nicola Monteleone,MD for their precious contributions.
Ethical standards  The authors’ Institutional Review Board approved
the study and follow-up, respecting the criteria of the Declaration of
Helsinki; all subjects accepted the proposed treatment and follow-up
after an adequate information and consent.
Conflict of interest  The authors declare that they have no conflict
of interest.
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