Professional Documents
Culture Documents
Oswald
Patrick J. Cahill
77 Amer F. Samdani
Randal R. Betz
Stapling Techniques
766
occur with the use of the Nitinol staple. This is due to the nickel
Potential Benefits of
crystal structure in Nitinol, which is different than the structure
TABLE 77.1 Bracing, Vertebral Body
of nickel in stainless steel where nickel can occasionally leach
Stapling, and Fusion out and cause sensitivity issues. Titanium is considered a bio-
logically safe implant material.33 No method of sterilization has
Independent
been shown to affect Nitinols properties.27
Curve Curve Motion of Patient
Puttlitz et al evaluated differences in thoracic spine range of
Stabilization Correction Preservation Compliance motion due to placement of Nitinol staples in an immature
Bracing 0 0 bovine biomechanical model.25 They determined that staples
Stapling were able to significantly restrict motion while not achieving
Fusion 0 the motion reductions associated with fusion. Axial rotation
and lateral bending were significantly limited with lateral sta-
ples without clear superiority between two- and four-prong
staples. Puttlitz et al demonstrated that by adding an anterior
heights to establish absolute vertebral body growth. Anterior staple, overall flexionextension was significantly decreased.25
vertebral stapling, although able to control progressive wedg- Betz et al demonstrated the feasibility, safety, and utility of
ing and scoliosis at the apical segment, was not able to fully vertebral body stapling for the treatment of AIS in a group of
reverse the HueterVolkmann effect. During the tethering 21 patients4 (Figs. 77.1 and 77.2). In this study, there were no
period, all goats had a relative and absolute decrease in con- major and three minor complications, which included a seg-
cave growth (78%) and an increase in convex growth (33%) at mental vein injury, a chylothorax, and a mild case of pancreati-
the apical segment compared with controls. During the treat- tis. No staple dislodgement or movements were noted.
ment period, the relative modulation of growth with stapling
demonstrated modest correction of wedging at the apical seg-
ment (2.2) versus untreated goats, which showed progres- INDICATIONS FOR STAPLING
sion (3.5). However, absolute modulation of growth was not
able to fully reverse the HueterVolkmann effect; at the apical Stapling is indicated in girls younger than 13 years and boys
spinal segment, growth was decreased on both the concavity younger than 15 who are Risser 0 or 1 or have at least 1 year of
(10%) and convexity (18%).7 growth remaining by wrist X-ray. The thoracic and lumbar cor-
Wall et al induced spine curvature in the coronal plane (0.8 onal curves should measure less than 45, with minimal rota-
to 22.4) in a normal porcine model utilizing spinal hemiepi- tion, and flexibility to less than 20. The sagittal thoracic curve
physiodesis with a staple. Histological evaluation of the porcine should measure less than 40, due to the theoretic potential of
growth plate demonstrated chondrocyte hypertrophy on the the staples to induce kyphosis. If the thoracic curve measures
stapled side indicating structural changes in the growth plate.32 35 to 45 and does not bend below 20, then the senior author
Since the early use of staples for the spine by Nachlas and will consider adding a posterior rib to spine hybrid construct at
Borden22 and Smith et al,28 the design and metal composition the same time, doing the posterior first (Figs. 77.3 and 77.4).
have continued to evolve. The early stainless steel staples were For a patient in whom the curves do not measure less than 20
originally designed for use in long bones and were ill suited for on first erect film, a corrective brace will be worn until the
the motion seen in the spine; the rigid implant was prone to curves measures below 20.
dislodge. In response to these limitations, Medtronic Sofamor
Danek (Memphis, TN) designed staples specifically for the
spine constructed of Nitinol, a shape memory alloy. The Food CONTRAINDICATIONS TO STAPLING
and Drug Administration has given 510(k) approval for Nitinol
shape memory staples for fixation of a bone screw in the ante- Early failures in the Betz et al studies occurred in patients with
rior spine as well as for hand and foot osteotomies. The staples preoperative curves greater than 50 and in those with second-
are not approved for use across the disc space and are used off ary curves greater than 25, which were not stapled. Additional
label. The prongs of the staple are straight when cooled but contraindications included greater than 40 kyphoscoliosis, any
bend into a C shape when introduced into the body, provid- medical contraindication to general anesthesia, reduced pul-
ing more secure fixation than possible with parallel stainless monary function, or a known hypersensitivity to nickel.3,4
steel staples. The temperature at which the staples undergo
transformation can be controlled by the manufacturing pro-
cess.27 With shape memory staples that crimp when warmed, SURGICAL TECHNIQUES
Braun et al, in their goat scoliosis model, demonstrated slight
back-out of 27% of 56 staples but with no complete dislodge- Preoperatively, posteroanterior (PA) and lateral standing films
ments.10 Back-out was not an issue in a recent human trial.3 are evaluated and the levels of the major scoliotic curve identi-
Nitinol is a biocompatible metal alloy of 50% titanium and fied. In general, staples are placed on the convexity of each level
50% nickel with extensive clinical experience in cardiovascular within the measured curve. General anesthesia is induced with a
stents,13,16 and no injury has been seen to surrounding tissues double lumen endotracheal tube. The double lumen tube pro-
in animal or human experiences.31 In addition, Nitinol has vides for both single lung ventilation and deflation of the non-
been utilized in orthodontic appliances due to its low corrosion ventilated (convex) lung for superior visualization. The patient
rate.27 Implant studies in animals demonstrate minimal eleva- is placed in the lateral decubitus position with the convex side of
tions of nickel in tissues in contact with Nitinol. While nickel the curve facing up with all bony prominences well padded. Two
sensitivity occurs in people very rarely, it is not expected to pads are placed under the pelvis and two pillows are positioned
A B C
D E F
Figure 77.1. Posteroanterior (A) and lateral (B) erect radiographs of a 12-year-old girl demonstrate a 31
right thoracic curve and 15 thoracic kyphosis. Preoperative bending films (C and D) demonstrate the flex-
ibility of the curve. The patient underwent a thoracoscopic vertebral body stapling from T5-T12. Her first
erect X-rays (E and F) demonstrate curve correction to 19. Latest follow-up at 4.1 years postoperatively
(continued)
A B C
Figure 77.2. (A) Posteroanterior (PA) and (B) lateral erect radiographs of a 7-year-old boy demonstrate a
30 right thoracic curve and 8 of thoracic kyphosis. (C and D) Bending films demonstrate a flexible thoracic
curve, which is completely correctible. (continued)
D E F
between the arms with the endotracheal tube situated in fluoroscopic visualization and baseline neuromonitoring, the
between the pillows. Fluoroscopic images are then obtained in patient is prepped as if for a thoracotomy. This is done in case
order to confirm the appropriate spine level (Figs. 77.5 and the procedure needs to be converted to a thoracotomy, should
77.6). Each of the levels within the major curve (as measured complications arise. Staples are allowed to cool for at least
on preoperative standing radiographs) is selected for stapling. 45 minutes. Once adequately cooled, the staples are placed
Neuromonitoring is used even though the risk of neurological onto their inserters, where they remain on ice until insertion.
complications is extremely low. If a segmental vessel should For thoracic curves, a thoracoscopic-assisted approach is
require ligation, then neuromonitoring is an important adjunct preferred. The initial portal is made in the fifth to seventh
to the procedure. Once adequately positioned with good intercostal interspace along the anterolateral chest line for
A B C
Figure 77.3. (A) This is a 9-year-old girl with a 55 right thoracic curve. On right bending film, the curve
reduces to 15. Her trunk height is still relatively short compared with that of her parents, and they are desir-
ous of an alternative to bracing and eventual fusion. (B and C) These are the postoperative radiographs of a
fusionless strategy. First, a posterior hybrid rod is placed from T6-7-8 to the L1 lamina. This rod is inserted
with two small incisions, one over the proximal sites and one over the lumbar spine. The rod is passed subcu-
taneously. After the spine is distracted into its corrected position, the patient is rolled to a lateral decubitus
position, and vertebral body stapling is performed from T7 to T12. It is anticipated that the patient will
undergo an initial lengthening in 6 months and then approximately yearly after that, which is the reason the
rod is left long at both ends of the construct. The plan will be to remove the rod at skeletal maturity, and it is
anticipated that the curve would be maintained at less than 30.
visualization with the scope. Staples are inserted through addi- gentle pull of the clamp. After staple insertion, a chest tube is
tional working portals in the posterior axillary line created placed to prevent a pneumothorax and to allow for drainage of
under thoracoscopic visualization (Fig. 77.7). Another access any postoperative effusions.
option is two minithoracotomy incisions with one centered at If hypokyphosis (kyphosis 10) exists, correction can be
T4-5 and the other at T9-10. If one encounters problems with attempted by placing the staples more anteriorly or by applying
one lung ventilation, then two minithoracotomies are just as a third staple (Fig. 77.11A). Generally, all staples are placed
effective for access. Upon access, appropriate levels are con- directly lateral on the vertebral body just anterior to the rib
firmed with fluoroscopy. A radiopaque trial instrument is uti- head. If hypokyphosis is present, then at the apical one or two
lized to determine the proper size of the staple (3 to 10 mm) discs an additional two-prong staple is placed just anterior to
and to create pilot holes. The smallest staple that is able to span the first staple(s). Occasionally, the T4 and T5 vertebrae are
the growth plates and disc is utilized. In most cases, the parietal too small to accommodate a four-prong staple, and a two-prong
pleura is not excised and the segmental vessels are preserved. staple is utilized. If possible, four-prong staples are used because
Occasionally, a small incision in the parietal pleura is required they decrease surgical time at each level (Fig. 77.11B). If the
to gently move the vessels away from the staple. The trial instru- diaphragm requires partial reflection at the thoracolumbar
ment is lined up on the vertebral body, and AP and lateral junction for staple placement, it should be repaired.
images confirm the location and proper placement. The trial is In the lumbar spine, vertebrae may be approached through
tapped into vertebral body in preparation for the staple two different techniques. One option is a miniopen retroperito-
(Fig. 77.8). Staples are sized based on the distance between the neal approach. This involves anterior-to-posterior retraction of
prongs once clamped down in vitro. Staples come in two-prong the psoas to provide visualization of the posterior one third of the
(Fig. 77.9A) and four-prong (Fig. 77.9B) varieties. Once the disc space. Alternatively, a second option is the minimally invasive
trial is fully seated, repeat images are taken, the trial is removed, transpsoas approach using a tube system in a manner popular-
and the staple is introduced and malleted into place ized by the lateral lumbar interbody fusion (XLIF) procedure
(Fig. 77.10). Throughout introduction, the staples position is (Figs. 77.12A and B). With this technique, the psoas is bluntly dis-
confirmed on both AP and lateral fluoroscopic views. If a staple sected in line with its longitudinal fibers over the posterior half of
is found to be incorrectly positioned, it can be removed with a the disc. During psoas dissection, direct electromyography
A B C
Figure 77.4. (A and B) These are the preoperative anteroposterior and lateral radio-
graphs of a 10-year-old girl with a 48 lumbar curve. She has open triradiate epiphyses, is
Risser 0, and is premenarchal. The patient and family are adamant that they do not wish
to have a fusion if at all possible. (C and D) These are the immediate postoperative films.
The patient had first a percutaneous placement of pedicle screws from T12 to L2. A per-
cutaneous rod was inserted, and the spine was derotated and locked in place. The rod is
specifically left long to allow for future lengthenings. The patient was then rolled to a left
lateral decubitus position and the stapling was performed between T11 and L3. The
patient was then rolled to a right lateral decubitus position and underwent stapling from
T6 to T11. It is anticipated that the lumbar distraction rod may be lengthened once,
possibly twice, but then removed when it is felt that the spine is substantially corrected
D
and stable.
POSTOPERATIVE MANAGEMENT
Postoperatively, the chest tube is removed once output is less
than 100 cc per 24 hours. In Betzs initial series, chest tubes were
left in for an average of 3.8 days, and patients were discharged
after an average hospital stay of 6.6 days.3 The current regimen
is to remove the chest tube at 1 day and discharge in 3 days.
Early in the Betz cohort, the postoperative regimen was a
noncorrective thoracolumbosacral orthosis (TLSO) full time for
Figure 77.6. A lateral/medial image is used to again confirm the 4 weeks, with no restrictions of activity thereafter. Currently, a
vertebral levels to be stapled and also to center the portals in the brace is not utilized for thoracic curves and activities are restricted
posterolateral line (Courtesy of Medtronic Sofamor Danek, Memphis, for only 1 month. For lumbar curves, we use a corset for 6 weeks
TN). to remind the patient to limit motion. After 6 weeks there are
A B
COMPLICATIONS
Figure 77.11. (A) Generally, two staples are utilized at each verte-
bral segment. This can be in the form of two single staples, which pro- Betz and colleagues have utilized 1900 staples on more than
vides the flexibility of adding a third anterior staple if desired. 150 patients. In two patients, a staple became completely dis-
(B) However, to decrease operative time, a double staple is used when lodged from the spine and was free within the chest. A thoraco-
appropriate (Courtesy of Medtronic Sofamor Danek, Memphis, TN). scopic assisted retrieval was performed in both cases. No
damage to the great vessels, heart, or lungs was noted, and no
absolutely no restrictions of activity. Patients are seen at 1 and 2 further complications occurred. There have been two cases in
months for wound checks and then every 6 months until skeletal which a staple (one staple in each case) backed out by only 2
maturity with standing PA and lateral radiographs to evaluate the mm. Four four-prong staples of an early design were found to
curve.3 If the curves on the first erect film do not measure less have fractured at the waist, although they did not back out. The
than 20, then the patient wears a corrective brace (usually a design was then changed.
nighttime Providence brace or a standard Boston brace [8 to 12 In the series of 29 patients described above in the Expected
hours per day]) until the curve measures less than 20 out of the Outcome and Results section, there were two minor complica-
brace. tions, including superior mesenteric artery syndrome and
atelectasis due to a mucous plug. There were no instances of
staple dislodgement or neurovascular injury.
EXPECTED OUTCOMES AND RESULTS Additional complications reported in prior articles published
by the senior author3,4 included one major and five minor com-
Betz et al5 retrospectively reviewed 28 out of 29 patients (96%) plications. The major complication occurred in a 4-year-old
with idiopathic scoliosis treated with vertebral body stapling patient with infantile idiopathic scoliosis who had an uncompli-
followed for a minimum of 2 years using the aforementioned cated thoracoscopic stapling from T5 to T12 with a rupture of a
Success Failure
pre-existing unrecognized diaphragmatic hernia that required after removal of the two distal staples, the patients pain was
emergency repair. Minor complications included puncture of a relieved.3,4
segmental spinal vein with a staple prong requiring conversion
to a mini-incision thoracotomy to ligate the vein (this was the
first case, without all the trials and staple sizes now available); a CONCLUSION
chylothorax from a staple prong puncture of the thoracic duct at
T12 not noticed at surgery but successfully treated conservatively The authors are very enthusiastic about stapling for idiopathic
with a chest tube and total parenteral nutrition; mild pancreati- scoliosis. The indications continue to evolve. Where previously we
tis, which resolved with a low-fat diet; and clinically significant considered this procedure to be an alternative to bracing, we now
atelectasis treated conservatively in two patients. better understand growth modulation and look for cases where
One patient had lumbar pain with a bone scan demonstrat- correction of undesired cosmetic trunk shapes may be realized.
ing increased uptake at the staplebone interface. Three weeks We are still cautious in recommending the stapling procedure to
approximately 10% to 20% of those who may be candidates. We 12. Climent JM, Sanchez J. Impact of the type of brace on the quality of life of adolescents with
spine deformities. Spine 1999;24:19031908.
try to choose children who have a very high risk of progression, 13. Cragg AH, DeJong SC, Barnhart WH, et al. Nitinol intravascular stent: results of preclinical
have progressed despite bracing, or who are troubled by the self- evaluation. Radiology 1993;189:775778.
14. Fallstrom K, Cochran T, Nachemson A. Long-term effects on personality development in
image implications of bracing. However, we are beginning to
patients with adolescent idiopathic scoliosis. Influence of type of treatment. Spine
offer stapling when we think that correction may be possible, as 1986;11:756758.
we are gaining more confidence in the procedures ability to 15. Karol LA. Effectiveness of bracing in male patients with idiopathic scoliosis. Spine
2001;26:756758.
obtain correction. Hopefully, genetic tests such as the ScoliScore 16. Kujala S, Pajala A, Kallioinen M, et al. Biocompatibility and strength properties of nitinol
will help us better define the best candidates in the future. shape memory alloy suture in rabbit tendon. Biomaterials 2004;25:353358.
17. Lindeman M, Behm K. Cognitive strategies and self-esteem as predictors of brace-wear
noncompliance in patients with idiopathic scoliosis and kyphosis. J Pediatr Orthop
1999;19:493499.
ACKNOWLEDGMENTS 18. Lonstein JE, Carlson JM. The prediction of curve progression in untreated idiopathic sco-
liosis during growth. J Bone Joint Surg Am 1984;66:10611071.
19. MacLean WE, Green NE, Pierree CB, et al. Stress and coping with scoliosis: psychological
The authors acknowledge Robert Decker, MD, and Carolyn effects on adolescents and their families. J Pediatr Orthop 1989;9:257261.
Hendrix for their contributions to this chapter. 20. Mente PL, Stokes IA, Spence H, et al. Progression of vertebral wedging in an asymmetri-
cally loaded rat tail model. Spine 1997;22:12921296.
21. Nachemson AL, Peterson LE. Effectiveness of treatment with a brace in girls who have
adolescent idiopathic scoliosis. A prospective, controlled study based on data from the
REFERENCES Brace Study of the Scoliosis Research Society. J Bone Joint Surg Am 1995;77:815822.
22. Nachlas IW, Borden JN. The cure of experimental scoliosis by directed growth control.
1. Andersen MO, Andersen GR, Thomsen K, et al. Early weaning might reduce the psycho- J Bone Joint Surg Am 1951;33:2434.
logic strain of Boston bracing: a study of 136 patients with adolescent idiopathic scoliosis 23. Noonan KJ, Weinstein SL, Jacobson WC, et al. Use of the Milwaukee brace for progressive
at 3.5 years after termination of brace treatment. J Pediatr Orthop B 2002;11:9699. idiopathic scoliosis. J Bone Joint Surg Am 1996;78:557567.
2. Bengtsson G, Fallstrom K, Jansson B, et al. A psychological and psychiatric investigation of 24. Peterson LE, Nachemson AL. Prediction of progression of the curve in girls who have
the adjustment of female scoliosis patients. Acta Psychiatr Scand 1974;50:5459. adolescent idiopathic scoliosis of moderate severity. Logistic regression analysis based on
3. Betz RR, DAndrea LP, Mulcahey MJ, et al. Vertebral body stapling procedure for the treat- data from the Brace Study of the Scoliosis Research Society. J Bone Joint Surg Am
ment of scoliosis in the growing child. Clin Orthop Relat Res 2005;5560. 1995;77:823827.
4. Betz RR, Kim J, DAndrea LP, et al. An innovative technique of vertebral body stapling for 25. Puttlitz CM, Masasru F, Barkley A, et al. A biomechanical assessment of thoracic spine sta-
the treatment of patients with adolescent idiopathic scoliosis: a feasibility, safety, and utility pling. Spine 2007;32:766771.
study. Spine 2003;28:S255S265. 26. Rowe DE, Bernstein SM, Riddick MF, et al. A meta-analysis of the efficacy of non-operative
5. Betz RR, Ranade A, Samdani AF, et al. Vertebral body stapling: a fusionless treatment treatments for idiopathic scoliosis. J Bone Joint Surg Am 1997;79:664667.
option for a growing child with moderate idiopathic scoliosis. Spine 2010;35:169176. 27. Sanders JO, Sanders AE, More R, et al. A preliminary investigation of shape memory alloys
6. Blount WP. A mature look at epiphyseal stapling. Clin Orthop Relat Res 1971;77:158163. in the surgical correction of scoliosis. Spine 1993;18:16401646.
7. Braun JT, Hines JL, Akyuz E, et al. Relative versus absolute modulation of growth in the 28. Smith AD, Von Lackum WH, Wylie R. An operation for stapling vertebral bodies in con-
fusionless treatment of experimental scoliosis. Spine 2006;31:17761782. genital scoliosis. J Bone Joint Surg Am 1954;36:342348.
8. Braun JT, Hoffman M, Akyuz E, et al. Mechanical modulation of vertebral growth in the 29. Stokes IA, Aronsson DD, Spence H, et al. Mechanical modulation of intervertebral disc
fusionless treatment of progressive scoliosis in an experimental model. Spine 2006;31: thickness in growing rat tails. J Spinal Disord 1998;11:261265.
13141320. 30. Stokes IA, Spence H, Aronsson DD, et al. Mechanical modulation of vertebral body growth:
9. Braun JT, Ogilvie JW, Akyuz E, et al. Experimental scoliosis in an immature goat model: a implications for scoliosis progression. Spine 1996;21:11621167.
method that creates idiopathic-type deformity with minimal violation of the spinal ele- 31. Veldhuizen AG, Sanders MM, Cool JC. A scoliosis correction device based on memory
ments along the curve. Spine 2003;28:21982203. metal. Med Eng Phys 1997;19:171179.
10. Braun JT, Ogilvie JW, Akyuz E, et al. Fusionless scoliosis correction using a shape memory 32. Wall EJ, Bylski-Austrow DI, Kolata RJ, et al. Endoscopic mechanical spinal hemiepiphysiod-
alloy staple in the anterior thoracic spine of the immature goat. Spine 2004;29:19801989. esis modifies spine growth. Spine 2005;30:11481153.
11. Braun JT, Ogilvie JW, Akyuz E, et al. Creation of an experimental idiopathic-type scoliosis in an 33. Wever DJ, Veldhuizen AG, Sanders MM, et al. Cytotoxic, allergic and genotoxic activity of
immature goat model using a flexible posterior asymmetric tether. Spine 2006;31:14101414. a nickel-titanium alloy. Biomaterials 1997;18:11151120.