Stryker Hansson Pin System Manual

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5
• Slipped Capital Femoral Epiphysis
Operative Technique
Hansson
Pin System
Pediatrics
Page 2
2
Contents
Introduction and Rationale 3
R
elative Indications & Contraindications 4
Features & Benefits 5
Operative Technique
Patient Positioning 6
Reduction 7
Optional Stabilization Guide Wire Insertion 8
Determining the Incision and Insertion Points 9
Skin Incision and Guide Wire Insertion 10
Drilling and Measurement 11
Instrument-to-Pin Assembly 12
Insertion of the Hansson Pin 13 and Activation of the Hook
Instrument Removal 14
Postoperative Regime 15
Pin Removal 16
Ordering Information
Implants 17
Instruments 18
References 19
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3
Introduction
The Hansson™ Pin system, designed by Professor Lars Ingvar Hansson at the University of Lund in Sweden, w
as developed based on research concerning the effects of implants on the blood supply to the femoral head.
Specifically developed for the treatment of slipped capital femoral epiphysis, the Hansson Pin system has been designed to minimise surgical trauma to the patient and offer secure, stable fixation with reduced risk of healing complications for all grades of fracture.
Twenty years of successful clinical studies have been carried out to enhance the Hansson™ Pin System to its current form. This work is summarized in 6 theses and more than 70 published articles.
Rationale
The methodology involves a cylindrical pin inserted in a drill hole which attaches to the femoral head via a hook, providing strong, stable fixation through a simple and precise procedure. The drill hole and pin run at right angles to the growth zone and are, depending on the degree of slipping, r
e
lat
ively centrally located in the femoral neck and head. T
he pin is 10-20mm longer than the
dr
il
l hole t
o al
lo
w c
ontinued growth in the length of the femoral neck. S
lips of up to 60° can be stabilised
b
y ost
e
osynthesis.
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4
Relative Indications & Contraindications
Slipped Capital Femoral Epiphysis
Adult Femoral Neck Fractures
The physician’s education, training and professional judgement must be relied upon to choose the most appropriate d
e
v
ice and treatment. Conditions presenting an increased r
isk of implant failure include:
• Any active or suspected latent
infection or marked local inflammation in or about the aff
ected area.
C
ompromised vascularity that would inhibit adequate blood supply to the fracture or the operative site.
• Bone stock compromised by disease, inf
e
c
tion or prior implantation that
can not p
r
o
v
ide a
dequate support
and/or fixation of the devices.
Material sensitivity, documented o
r s
usp
ected.
O
b
esit
y. An obese patient can produce loads on the implant that can lead to failure of the fixation of the d
e
v
ic
e or to failure of the device
itself.
• Patients having inadequate tissue coverage over the operative site.
• Implant utilization that would interfere with anatomical structures or physiological performance.
A
n
y me
ntal or neuromuscular disorder which would create an unacceptable risk of fixation failure or c
o
mplicat
io
ns in postoperative care.
O
the
r me
dical o
r surgical conditions which would preclude the potential benefit of surgery.
Detailed information is included in the instructions for use being provided with each implant.
See package insert for a complete list o
f
potential adverse effects and contraindications. The surgeon must discuss all relevant risks, including the se
r
vice life of the device and the need for postoperative protection of the implant with the child’s parents, w
hen necessary.
Relative Contraindications
Contraindications
Indications
Due to a lack of any supportive clinical experience, the Hansson Pin is not recommended for use with paediatric hip fractures.
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5
Features & Benefits
Preventing diastasis and further displacement of the epiphysis
The risk of further intraoperative d
isplacement of the femoral head is reduced by drilling a channel for the H
ansson Pin with the femoral head fixed with kirschner wires. The smooth outer pin allows the surgeon to gently push the implant through the channel, reducing the risk of diastasis between the femoral neck and the head.
1
Lasting stable fixation
The hook resists loosening of the fixation to the femoral head as the longitudinal growth of the femoral neck retracts the pin in the channel thereby stabilizing the femoral head. Loosening of the implant is potentially reduced because of resorption and growth of the femoral neck under normal conditions.
1
Reducing the risk of unequal bone length
The continued growth of the femoral n
eck in cases with Slipped Capital Femoral Epiphysis is an indication o
f undisturbed intra- and postoperative vascularization, as the nutrition for the proliferating cells of the growth plate is provided by the epiphysial vessels. By preserving the blood supply, the Hansson Pin System reduces the risk of unequal bone length.
1
Easy extraction
The risk of the pin being trapped in the bone is reduced as the pin surface is smooth. The hook is easily withdrawn back into the body of the pin, which can then be removed.
1
Frontal view
Lateral view
Slipped Capital Femoral Epiphysis
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6
Operative Technique
Step 1 - Patient Positioning
Correct positioning of the patient on the fracture table is essential for avoiding problems and complications d
uring surgery (Fig. 1).
Place the patient in supine position on the fracture table.
Healthy side: Position the leg on the healthy side with the hip in flexion and slight abduction so that the C-arm can be adjusted intra-operatively for both the anterior/posterior and the lateral/medial views. This is necessary to obtain a true lateral view of the femoral neck and head (Fig. 2). The purpose of this view is to avoid the penetration of the end of the pin through the surface of the femoral head.
Furthermore, again for avoiding pin penetration, the surface of the femoral head must be seen continuously when moving the C–arm from the horizontal position to the vertical position.
Slipped side: Position the hip in full extension with neutral position between abduction and adduction.
Fig. 1 – Position Patient; C-Arm in A/P View
Fig
.
2 – Position Patient; C-Arm in L/M View
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7
Operative Technique
Step 2 - Reduction
Apply the surgical boot to the foot.
Mild traction is applied for the sole purpose of maintaining the leg in the horizontal plane. Additional support under the thigh may be necessary.
Rotate the foot internally by 30- 60° and fix in position. This is so that the femoral neck is parallel to the radiation beam in the lateral view (Fig. 3).
Stable (Chronic) Slips
Eighty to ninety percent of slips are stable (or chronic).
Stable slips are always pinned in situ. Any attempt to perform a closed reduction on a chronic slip may lead to avascular necrosis.
Gradual bone remodelling has taken place as a response to the insidious slipping of the femur away from the femoral head. (Fig. 4) This is the body's natural attempt to adapt the geometry of the proximal femur in order to maintain a functional hip joint. The remodelling is therefore ossified and reduction is not possible.
The stable slip is pinned with the intention of preventing further slippage, as well as preventing the possibility of acute-on-chronic traumatic changes, which could be devastating for the vascularization of the femoral head.
The surgical treatment of a stable slip can the
r
e
fore be planned in advance
but must be considered urgent.
Fig. 3 – Internal Rotation of the Hip
Fig. 4 – Bone Remodelling
30- 60°
Unstable (Acute) Slips
Unstable slips (where the event is recent, the child cannot weight-bear and the threat of avascular necrosis of the femoral head is an immediate danger) must be pinned without delay from the moment of the patient's arrival in the clinic.
This is an emergency situation.
Some chronic remodelling may be noted on X-ray and again, this ossified modification of the hip joint cannot be reduced in surgery.
The acute or unstable portion of the slip is treated with closed reduction by internal rotation and then pinned. The chronic portion is left as it is.
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8
Step 3 – Stabilization Guide Wire Insertion
When treating unstable (acute) s
lips a Guide Wire may be used. Using biplanar floroscopy, it is inserted percutaneously in the trochanteric region into the femoral neck and h
ead for intraoperative stabilization.
(Fig. 5).
Fig
.
5
Operative Technique
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9
Step 4 – Determining the Incision P
oint and Implant Position
S
lipping of the femoral head occurs in a true posterior direction. The Hansson Pin must be positioned in the central part of the femoral head.
To achieve this, the pin must be inserted anterior-laterally in the greater trochanter and then directed posteriorly (Fig. 6).
A prerequisite for being able to correctly position the Hansson Pin is to insert a Ø2.4mm Guide Wire prior to drilling.
Guide Wire Insertion Point – Anterior/ Posterior View:
Position a Guide Wire on the skin of the anterior aspect of the thigh. Verify by anterior/posterior fluoroscopy that the Guide Wire is in the correct position in the central part of the femoral neck and head (Fig. 7). Mark the position of the Guide Wire on the anterior surface of the thigh.
Lateral/ Medial View:
Now position the Guide Wire over the skin on the lateral aspect of the thigh. Verify by lateral/medial fluoroscopy that the Guide Wire has been positioned to e
nte
r p
ost
eriorly towards the central part of the femoral head (Fig. 8) M
ark the position of the Guide Wire
o
n the lat
e
r
al asp
ect of the thigh.
The intersection of these two lines at the ant
e
r
io
r
-lat
e
ral aspect of the thigh at the level of the lesser trochanter r
e
p
resents the optimal point for
p
e
r
cu
tane
ous inse
r
tion of the Guide
Wire (Fig. 9).
Fig. 6 – Final Implant Position to Achieve
Fig. 8 – L/M X-Ray of Guide Wire over skin
Fig. 7 – A/P X-Ray of Guide Wire over skin
Fig. 9 – Incision and Guide Wire Insertion Point
Operative Technique
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10
Step 5 – Skin Incision and Guide Wire Insertion
Make a 20mm incision at the site where the two lines on the thigh intersect. The insertion point on the a
nterior-lateral face of the proximal femur is identified at the level of the l
esser trochanter (Fig. 10).
If harder cortical bone is anticipated (such as with a child being treated with chemotherapy), the surgeon may prefer to pre-drill the cortex with the optional drill.
I
nsert the Guide Wire over the Guide Wire Bush and Drill Sleeve. Using a p
ower drill, begin insertion from the
ant
erio-lateral cortex, crossing the
e
piphysis and targeting the center of the femoral head. According to the severity of the slip, the guide wire will be in an oblique position in the femoral neck. Use frequent biplanar fluoroscopic control to verify the alignment of the Guide Wire in both the anterior/ posterior and lateral/medial plane.
This is to ensure that the centre of the femoral head will be reached.
If the direction of the Guide Wire appears to deviate from the centre o
f
the femoral head, stop the procedure, remove the Guide Wire, and recommence until correct positioning of the Guide Wire is obtained (Fig. 11). Advance to within 5mm of the subchondral bone to anticipate the necessary space for the hook to be extruded.
R
emove the Guide Wire Bush.
Fig. 10 – Skin Incision
Operative Technique
Fig. 11 – Guide Wire Insertion
Final I
mplant P
osit
io
n t
o
A
chieve
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11
Step 6 – Drilling and Measurement
Insert the Cannulated Drill over the Drill Sleeve and the Guide Wire. The Drill Sleeve is pressed against the lateral cortex of the femur and the drill i
s advanced towards the centre of the
femoral head (Fig. 12).
Use frequent fluoroscopy while drilling to avoid medial migration and penetration of the Guide Wire through the joint surface of the femoral head.
If medial migration is detected, remove the Cannulated Drill and clean the bone debris from the cannulation.
R
einsert the Cannulated Drill over
the G
uide Wire and Drill Sleeve and advance to within 5mm of subchondral bone.
Leave the Drill Sleeve in place.
Read the measurement shown on the drill at the level of the lateral aspect of the Drill Sleeve (See zoom of Fig. 12). Choose a Hansson Pin which is about 15 to 20mm more than the measurement shown. This is to allow the femoral neck to continue its growth along the pin and to ease pin removal once the physis has closed and growth has c
ompleted.
According to the amount of subcutaneous tissue which covers the G
r
eat
e
r Trochanter, a longer pin protruding from the patient's lateral cortex may not be tolerated.
Therefore the amount of pin which may protrude is limited. In this case, a smaller pin is used and a future operation to replace the pin with a longer one may be necessary.
Operative Technique
Fig. 12 – Drill and Measure
Direct reading of the length
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12
Operative Technique
Step 7 – Instrument-to-Pin Assembly
V
erify that the inner pin is completely withdrawn in the window of the outer b
ody and in correct position (Fig. 13).
Pass the Inner Introducer through the Outer Introducer and screw it into the Hansson Pin (Fig. 14). There are unequal tabs on the Outer Introducer which correspond with slots in the pin; the tabs and slots should securely mate when the Introducer Assembly is screwed onto the Hansson Pin.
The handles of the Inner and Outer Introducers need not be aligned.
F
ig.13
Fig. 14
Hansson Pin
Outer Introducer
Inner Introducer
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Step 8 – Insertion of the Hansson Pin and Activation of the Hook
I
nsert the Hansson Pin with the Introducer Assembly into the femoral c
hannel which has been pre-drilled. Ensure that the pin is fully inserted. Use fluoroscopy to verify the position of the Hansson Pin. (Fig 15).
There is an etched line on the handle of the Outer Introducer which indicates the Inner Pin’s point of exit. Verify that this guide line is in alignment with the femoral shaft. (Fig. 16). Thus the hook will be extruded in the superior direction as demonstrated in figure 17.
Insert the tip of the Introducer Handle through the hole in the Inner Introducer.
Maintain both the Outer and Inner Introducers in position.
Turn the Introducer Handle clockwise whilst gently pushing medially on the introducer assembly. Continue turning the Introducer Handle to completely deploy the hook using biplanar fluoroscopy. A mechanical stop is provided by the Inner Introducer (Fig. 17).
Operative Technique
F
ig. 15 – Insert Hansson Pin into channel
Fig. 16 – Verify hook position
Fig
.
17 – Activate hook
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14
Operative Technique
Step 9 – Instrument Removal
Maintain the Outer Introducer in position. Unscrew and then remove
the Introducer Handle followed by t
he Inner Introducer and the Outer
Introducer (Fig.18). Close the wound.
Fig.18
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15
Postoperative Regime
Stable Slip:
T
he patient is allowed to start walking using crutches and partial weight bearing on the operated side the first day after surgery. Usually the patient can be discharged f
rom the ward one to two days after surgery when he or she is capable of walking with crutches. Full weight bearing is possible after one week.
Unstable Slip:
T
he patient is allowed to start walking using crutches and partial weight bearing on the operated side the first day after surgery. Full weight bearing on the operated leg i
s not allowed until after six weeks.
Postoperative Activities ­Stable and Unstable:
Surgeons should instruct parents regarding appropriate and restricted activities during the treatment in order to prevent placing excessive stress on the implants which may lead to fixation or implant failure and accompanying clinical problems.
Surgeons should also instruct parents to report any unusual changes of the operative site to his/her physician.
The physician should closely monitor the patient if a change at the site has b
een detected.
Bilateral Slips:
Periodic X-Ray images should be taken o
f both hips to facilitate early detection
of contralateral slips.
Follow Up Examination – Stable and Unstable:
A six-week post-op follow up medical and radiological examination is recommended.
When assessing the follow-up X-ray, the surgeon must look for:
• Reliable anchorage of the hook in the femoral head.
• Protrusion of the end of the pin through the lateral cortex of the thigh.
The most accurate angle to view the protrusion of the pin is the lateral position, due to the insertion angle.
If the X-rays are satisfactory, then walking is permitted.
R
e
p
eat X-r
a
ys are necessary every 6
months until the physes have closed.
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16
Operative Technique
Pin Removal
S
tep 1
The arrowed end of the Inner Extractor is engaged with the inner pin’s thread and rotated clockwise until it stops (Fig. 18).
Step 2
The Outer Extractor is slid over the Inner Extractor until it is in contact with the outer pin (Fig. 19).
Note: If the Outer Extractor is not in
contact with the outer body of the H
ansson Pin, rotate the
Outer Extractor
only until it engages the flat sides of the Inner Extractor and push
the handle gently until it touches the tip of the outer body.
It is important not to exert any rotation on the Outer Extractor when the instrument is keyed by the flat sides of the Inner Extractor.
Step 3
Maintain the Outer Extractor in place.
I
nse
r
t the thr
eaded tip of the Extractor Handle into the Outer Extractor and turn it clockwise to engage the thread
e
d part of the Inner Extractor
Do not rotate the Outer Extractor.
See step (1) in figure 20.
Continue to turn the Extractor Handle until a mechanical stop is felt. This completely withdraws the hook into the outer pin.
Check under image intensification that the hook is fully retracted prior to pulling back the implant.
Once the hook is fully retracted, remove the implant along with the e
xtraction instruments.
See step (2) in figure 20.
I
n case the hook is removed on its own, leaving behind the outer pin, the outer pin is removed by assembling the Inner and Outer Introducers and removing the outer pin from the bone.
F
ig. 18 – Engage Inner Extractor with Inner Pin
Fig. 19 – Key Outer Extractor over Inner Extractor
Fig. 20 – Insert and turn Extractor Handle
(1)
(2)
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Ordering Information — Implants
Stainless Steel Pin Titanium
REF Length REF
mm
394070S 70mm 694070S 394075S 75mm 694075S 394080S 80mm 694080S 394085S 85mm 694085S 394090S 90mm 694090S 394095S 95mm 694095S 394100S 100mm 694100S 394105S 105mm 694105S 394110S 110mm 694110S 394115S 115mm 694115S 394120S 120mm 694120S 394125S 125mm 694125S 394130S 130mm 694130S 394135 * 135mm 694135* 394140 * 140mm 694140*
HANSSON PINS
Sp
ecial Order
N
ot
e:
St
e
r
ile Onl
y /
* Sp
e
cial Or
d
e
r N
o
n-St
erile
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18
Ordering Information — Instruments
REF Description
704501 Short Cannulated Drill Ø 6.7mm x 246mm with Jacobs fitting
704510 Protective Measuring Sleeve
704511 Guide-wire Bush
704515 Outer Introducer
704516 Inner Introducer
704517 Introducer Handle
704527 Extractor Handle
704528 Outer Extractor
704529 Inner Extractor
704505S Threaded Guide-wire Ø 2.4mm x 300mm (Single Use - Sterile Packed)
901704
St
erilisation Tray for Instruments (Lid and Insert)
O
p
t
io
nal Instrument
702448 Drill Bit Ø 1.4mm x 150mm (single use).
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References
References:
1. Hansson L.I. (1982): Osteosynthesis w
ith the Hook-Pin in Slipped Capital Femoral Epiphysis. Acta Orthop. Scand. 53: 87-96
2. Slipped Capital Femoral Epiphysis Journal of Pediatric Orthopaedics. 26(3):286-290, May/June 2006. Lehmann, Charles L. BS *; Arons, Raymond R. PhD +; Loder, Randall T. MD ++; Vitale, Michael G. MD, MPH +[S]
3. Bone Growth After Fixing Slipped Femoral Epiphysis: Brief Report J Bone Joint Surg (Br) 1988 ;70-B : 846-6. Hägglund, Gunnar ; Bylander, Birger ; Hansson, Lars Ingvar ; Selvik, Göran.
4. Radiographic Assessment of Coxarthrosis Following Slipped Capital F
emoral Epipysis, A 32-year follow-up study of 51 hips. Acta Radiologica 34 (1993) Fasc. 2 Hansson, G.; Jerre, R.; Sanders, S.M.; Wallin, J.
5. The Contralateral Hip in Patients Primarily Treated for Unilateral Slipped Upper Femoral Epiphysis, a long-term follow-up of 61 hips J Bone Joint Surgery (Br) 1994; 76­B:563-7. Jerre, Ragnar; Billing, Lars; Hansson, Göran; Wallin, Jan
6. L
o
ng-term Results After Nailing in situ of Slipped Upper Femoral Epiphysis A 30-year follow-up of 59 hips. T
he J
our
nal of Bone and Joint Surgery (Br) 1998;80-B:70-7 Hansson, G; Billing, B.; Högstedt, B.; J
e
r
re, R.; Wallin, J.
7. Prophylactic Pinning of the C
ontralateral Hip in Slipped Capital Femoral Epiphysis Evaluation of Long-Term Outcome for the Contralateral Hip with Use of Decision Analysis J
ournal of Bone and Joint Surgery, Inc. 2002 W. Randall Schultz, MD, MS, James N. Weinstein, DO, MS, Stuart L. Weinstein, MD and Brian G. Smith, MD
8. The Epidemiology of Slipped Capital Femoral Epiphysis: An Update Paper No: 050 Presented at the American Academy of Orthopaedic Surgeons 2005 Annual Meeting, Washington, DC – February 23, 2005 Michael G Vitale, MD; Charles Lehmann BS; Randall T Loder, MD
9. Osteosynthesis with the Hook-Pin in Slipped Capital Femoral Epiphysis, Hansson, L.I. (1982): Acta Orthop. Scand. 53: 87-96
10. Vitality of the Slipped Capital Femoral Epiphysis. Preoperative evaluation by tetracycline labeling. Hagglund, G., Hansson, L.I. and Ordeberg G. (1985).
T
hesis:
1. Physiolysis of the Hip. Epidemiology, n
atural history and long time results after closed treatment. Gunnar Ordeberg, 1986.
2. Physiolysis of the Hip. Epidemiology, etiology and therapy. Gunnar Hägglund, 1986.
Page 20
Stryker Trauma AG Bohnackerweg 1 CH-2545 S
e
lza
c
h
Switzerland
www
.osteosynthesis.stryker.com
T
he inf
ormation presented in this brochure is intended to demonstrate a Stryker product. Always refer to the package
inse
r
t,
p
roduct label and/or user instructions before using any Stryker product. Surgeons must always rely on their own clinical judgment when deciding which products and techniques to use with their patients. Products may not be available in all markets. Product availability is subject to the regulatory or medical practices that govern individual markets. Please contact your Stryker representative if you have questions about the availability of Stryker products in your area.
Stryker Corporation or its subsidiary owns the registered trademark: Stryker. S
wemac Orthopaedics AB owns the following trademark: Hansson Pin.
Literature Number:
982303
LOT A2806
US P
at
ents pending
Copyright © 2006 Stryker Printed in Switzerland
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