Managing Sternal Closure with Rigid Fixation

Transcription

Managing Sternal Closure with Rigid Fixation
Course Faculty
Sven Lehmann, MD
Department of Cardiac Surgery
Leipzig University of Leipzig, Heart Center Leipzig GmbH, Leipzig, Germany
Background:
•Specialist in cardiac surgery
•Senior physician
•Interest:
• Valve replacement
• Lungtransplantation
• Rigid sternum closure
Note: Dr. Lehmann is a Biomet Consultant
Course Goals
Goals for Today
1) Obtain a understanding of the bone remodeling process
2) Discuss how rigid fixation impacts bone repair
3) Provide you with the latest information on sternal closure
4) Allow you to gain hands on experience with rigid sternal fixation
5) Arm you with information that will help you go back to your practice and personalize the care you provide for each patient
Introduction
Does This Look Like Your Weekend??
The Right Tools Make a Big Difference
The same is true in surgery…
Sternal Plates
Various Tools for Closure…
Sternal Clamps
Sternal Cables
Sternal Suture / Wire
Double Wires
Sternal Band
So How Do you Know What to Use?
1) Have a deep understanding of the factors that affect bone repair
2) Know your patient’s history / demographics
Don’t Tune Out Yet!
Did You Know…
9 The sternotomy is the most common osteotomy worldwide
1
9 You cut more bone than most orthopedic surgeons
9 Bone repair can be the most painful part of your patient’s recovery
2
9 Side effects of poorly repaired bone can result in complications , and significant expenses to your facility
3
1)
2)
3)
4)
Raman, J. (2006). Sternal closure with titanium plating a paradigm shift in preventing mediastinitis. Interactive Cardiovascular and Thoracic Surgery, 5, 338.
McKee Foods Corporation v. James M Bumpus, June 23, 2008 Session, Nashville, TN
Shock‐wave therapy for unhealed fractured bones as effective as surgery. (2009, November 3). Retrieved from http://www.medicalnewstoday.com/articles/169536.php
Schneider, C. (2009). U.s. payment trends & hospital acquired conditions. Industry Whitepaper Series, 5, 7‐8.
4
Overview of SternaLock® System
SternaLock® Plate & Screw System
• Introduced by Biomet in 2003
• Stabilize & fixate anterior chest wall fractures
• Rigid fixation for sternal closure
• Plate & screw system
• System specific instrumentation
Sternum: Anatomy
Basic Anatomy of Sternum
• Elongated, flat bone
• Forms middle portion of anterior wall of thorax
• Manubrium support the clavicles
• Composed of three sections
• Manubrium
• Body
• Xiphoid
1)
(n.d.). The Sternum: osteology. Retrieved from http://education.yahoo.com/reference/gray/subjects/subject/27
Advanced Discussion of Sternum
Sternum
Cortical Outer Shell
•
•
1)
2)
Cancellous
Inner
1,2
1,2
Dense outer surface of bone
Forms protective layer
•
Compact bone
•
High resistance to bending & torsion
•
Imperative to structure & weight
(n.d.). Bone. Retrieved from http://en.wikipedia.org/wiki/Bone
Singh, A. (2007, May 20). How does Bone fracture healing occur!. Retrieved from http://boneandspine.com/fractures‐dislocations/bone‐fracture‐healing‐occur/ •
Spongy tissue
•
Help in formation & growth of bone
•
Interconnecting spaces containing bone marrow
Bone Repair Process
Starts with an Injury: Bone Fracture
Tibia / Fibula Fracture
1,2
1)
2)
Singh, A. (2007, May 20). How does Bone fracture healing occur!. Retrieved from http://boneandspine.com/fractures‐dislocations/bone‐fracture‐healing‐occur/ •
Fractures cortical and cancellous
bone
•
Causes bleeding of cancellous
bone
•
Fracture site swells
•
Damage to periosteum triggers nerves
Sternotomy is an Injury…
Sternotomy
1)
2)
Singh, A. (2007, May 20). How does Bone fracture healing occur!. Retrieved from http://boneandspine.com/fractures‐dislocations/bone‐fracture‐healing‐occur/ 1,2
•
Fractures cortical and cancellous
bone
•
Causes bleeding of cancellous
bone
•
Fracture site swells
•
Damage to periosteum triggers nerves
Bone Repair Process
2,3,4
(not rigidly fixated)
Normal Bone Repair…
Hematoma
(Inflammatory)
Soft Callus
Hard Callus
Remodeling
Timeframe1:
1‐2 Weeks
2‐3 Weeks
4‐16 Weeks
17 + Weeks
Comments:
* Painful
* Fragile
* Painful
* Fragile
* Less Painful
* More Stable
* Stable
Stage1:
Note: A patient’s habits and state of health can effect these times
1)
2)
3)
4)
Permission to utilize photos pending from Orthofix
(2006, Sepetmber 3). Inflammation: what you need to know. Retrieved from http://my.clevelandclinic.org/symptoms/Inflammation/hic_Inflammation_What_You_Need_To_Know.aspx
Broderick, J. (2005, November). Biology of bone repair. Retrieved from http://www.ota.org/res_slide/G07_Biology_of_Bone_Repair.ppt
Simon, S. (2006). Orthopedic basic science. American Academy of Orthopedic Surgeons. Bone Repair Process (Rigid fixation)
Rigidly fixated bone undergoes Direct Bone Repair …
3,4
Hematoma
(Inflammatory)
Remodeling
Timeframe1,4:
1‐2 Weeks
2‐4 + Weeks
Comments2:
* Painful
* Fragile
* Stable
Stage1,4:
Note: A patient’s habits and state of health can effect these times
1)
2)
3)
4)
Simon, S. (2006). Orthopedic basic science. American Academy of Orthopedic Surgeons. Keys to Direct Bone Repair …
1
1. Exact Reduction
2. Stable Fixation
3. Adequate Blood Supply
1)
Simon, S. (2006). Orthopedic basic science. American Academy of Orthopedic Surgeons.
The Break Can Impact Healing…
• Unclean / shattered bone needs to be cleaned up to ensure cancellous bone touches cancellous bone
• Clean break means easier approximation
Clean Break
Jagged Break
Stability
• Stability allows the vessels to grow across the fracture
1

Vessels are the key to carrying blood / nutrients

If vessels keep breaking due to movement, bone takes longer to heal
• Proper stabilization keeps your great work in place
1) (2008, May 26). Bone healing. Retrieved from http://www.footphysicians.com/footankleinfo/Bone_Healing.htm Stability: Some Motion is Good
Micromotion is Good …
1
1.
Allows for very small, controlled, motion between two segments
2.
Often not “seen” or felt by hand
3.
Promotes a controlled build up and break down ultimately leading to strong remodeling
1) Zardiaskas and Dillon, Initials. (n.d.). Encyclopedic handbook of biomaterials and bioengineering.
Macromotion is Bad …
1
1.
Allows for significant, uncontrolled, motion between two segments 2.
Able to see and palpate by pressing on adjacent segments
3.
Prevents segment from moving past the Callus formation and often results in scared tissue
Time
• Bone repair doesn’t happen overnight!
• Patients need to immobilize the site of fracture to allow for bone repair
1
1) 01‐50‐1215 Revision G: Warnings and Precautions for the use of the Biomet Microfixation Sternalock System
Bone Repair Process (stable vs. unstable)
1,2,3,4
Stable Bone1,2…
30 Days
Hematoma
60 Days
Remodeling
90 Days
Remodeling
Remodeling
90 Days w/ Plates & Screws
Unstable Bone1,2…
30 Days
Hematoma
1)
2)
3)
4)
60 Days
Soft Callus
Simon, S. (2006). Orthopedic basic science. American Academy of Orthopedic Surgeons. 90 Days
Hematoma
Thick Scar
90 Days w/ Wire
Recap: Keys to Bone Repair
1) Ensure a clean fracture
2) Good bone approximation to facilitate healing
¾
Cancellous to Cancellous
¾
Cortical to Cortical
1
3) Stability to allow vessels to grow across fracture
¾
Micromotion is good
¾
Macromotion is bad
4) Time to allow bone fusion
1) Simon, S. (2006). Orthopedic basic science. American Academy of Orthopedic Surgeons.
Side Effects of Bone Non‐Union
• Increased pain medication intake by patient
1
• Slower return to work / activity
• Extended risk of severe infection
3
• Patients forget your lifesaving work and only focus on pain
1)
2)
3)
(2005). Bone pain. Retrieved from http://www.chemocare.com/managing/bone‐pain.asp
McKee Foods Corporation v. James M Bumpus, June 23, 2008 Session, Nashville, TN
Francel, T. (2004). A Rational approach to sternal wound complications. Seminars in Thoracic and Cardiovascular Surgery, 16(1), 81‐91. 2
Patient Factors that Impact Bone Repair
Osteoporosis
Note: Insufficient quality or quantity of bone is a contraindication of rigid fixation.
• Bone mass is significantly lower than normal
• Bone is weak and brittle – difficult to fixate
• Screws do not anchor as well into thin, weak, osteoporotic bone
Good Quality
1)
(n.d.). Osteoporosis ‐ causes ‐ diagnosis ‐ symptoms ‐ treatment ‐ prevention. Retrieved from http://arthritis.about.com/od/osteopor/Osteoporosis_Causes_Diagnosis_Symptoms_Treatment_Prevention.htm
Poor Quality
Bone Mass
• As people age bone mass declines
• Women lose mass faster than men during menopause
Osteoporosis
• Lower bone mass leads to fragile bone, more difficult to fixate
1) (2009, December 2). Give Your bones a break ‐‐ a look at osteoporosis. Retrieved from http://teachhealthk‐12.uthscsa.edu/curriculum/bones/pa12pdf/1205B‐AK.pdf Smoking
Note: Limited blood supply is a contraindication of rigid fixation.
• Blood vessels constrict approx. 25% of their normal diameter
1
•
Decreases nutrients to bone
• Bone takes 2 months longer to heal
1
• Coughing puts large force on sternum
2
• Typically excluded from FDA trials in orthopedics – failure rate is 4 fold compared to non‐smokers
3
1)
2)
3)
Cluett, J. (n.d.). Smoking hurts bones. Retrieved from http://orthopedics.about.com/cs/brokenbones/a/smokingbones.htm
Casha, A.R. (1999). A Biomechanical study of median sternotomy closure techniques. European Journal of Cardio‐Thoracic Surgery, 15, 365‐369.
Simon, S. (2006). Orthopedic basic science. American Academy of Orthopedic Surgeons. Active Patients
Note: It is imperative for patients to follow post‐op instructions given by surgeon
• Patients typically want return to activity / work sooner
• Drying hair
• Golfing
• Picking up children
• Lifting groceries
• Working
• Exercising
• Patients need to immobilize the site of fracture to allow for bone repair
1
Other Factors the Effect Bone Repair …
1
• Non‐steroidal anti‐inflammatory drugs (NSAIDs)
1
• Aspirin
• Ibuprofen
• Naproxen
• Nutritional Status
1
• Steroid Use
1
1)
Simon, S. (2006). Orthopedic basic science. American Academy of Orthopedic Surgeons. Recap: Bone Repair
Keys…
9 Clean surfaces (no bone wax)
9 Controlled vascularized site
9 Good approximation of adjacent extremities
9 Forces
9 Micromotion vs. macromotion
9 Time
Recap: Bone Repair
Patient Factors…
9 Bone quality
9 Smoking
9 Patient activity level
9 NSAIDs, Steroids & Nutrition
Natural Forces on the Sternum
Breathing & Coughing Forces
1
(sternotomy study)
• Maximum coughing places 150kg of force on sternum
1
• This equates to 25kg of force across each sternal wire
1
• At 20kg force, twisted wire starts to untwist
1
• There is a risk that severe coughing may cause wires to untwist
1
1)
Casha, A.R. (1999). A Biomechanical study of median sternotomy closure techniques. European Journal of Cardio‐Thoracic Surgery, 15, 365‐369.
Fixating the Sternum: Biomechanical Testing
Study Objectives
9 Compare fixation of cadaveric sterna by…
•
Wire circlage (3 peristernal @ manubrium & 5 trans‐sternal along body)
•
Rigid plate fixation construct #1 (1 L plate & 2 X plates)
•
Rigid plate fixation construct #2 (1 Box plate & 2 X plates)
9 Determine which rigid plate construct will provide the strongest and stiffest method of closure
Note> Study conducted by Lanny V. Griffin, Ph.D. – Professor and Chair of Cal Poly Biomedical Engineering Department, et. al (11/3/09)
Note: Bench testing is not necessarily indicative of clinical performance
1)
Griffin, L. (2009). Biomechanical comparison of wire circlage and rigid plate fixation for median sternotomy closure in human cadaver specimens. American Association for Thoracic Surgery, Methodology
9 43 cadaveric models divided into 3 groups…
Group A
Group B
Group C
9 Several biomechanical parameters evaluated…
•
1)
Stiffness, Yield Load, Post Yield Displacement, Ultimate Load
Griffin, L. (2009). Biomechanical comparison of wire circlage and rigid plate fixation for median sternotomy closure in human cadaver specimens. American Association for Thoracic Surgery, Test Pictures
43 Cadaveric Sternums Tested
Rostro‐Caudal Shear Testing
Anterior‐Posterior Shear Testing
Lateral Distraction Testing
1)
Griffin, L. (2009). Biomechanical comparison of wire circlage and rigid plate fixation for median sternotomy closure in human cadaver specimens. American Association for Thoracic Surgery, Wires
1)
Griffin, L. (2009). Biomechanical comparison of wire circlage and rigid plate fixation for median sternotomy closure in human cadaver specimens. American Association for Thoracic Surgery, Wires
“Box” Plate Construct
“L” Plate Construct
“Box” Plate Construct
“L” Plate Construct
Results
Other Observations
9 Under ultimate load, no plate constructs failed
9 Failure occurred when sternum separated from the ribs
9 Under ultimate load, wire construct failed
9 Failure occurred when wires broke apart
1)
Griffin, L. (2009). Biomechanical comparison of wire circlage and rigid plate fixation for median sternotomy closure in human cadaver specimens. American Association for Thoracic Surgery, Study Conclusions (cadaveric study)
1
9 Rigid fixation of the sternum using titanium plates and screws is biomechanically superior to wires
9 No statistically significant differences between the 2 plating constructs in lateral distraction testing
9 “L” plate configuration statistically superior to “Box”
plate configuration in rostro‐caudal shear testing
1)
Griffin, L. (2009). Biomechanical comparison of wire circlage and rigid plate fixation for median sternotomy closure in human cadaver specimens. American Association for Thoracic Surgery, Fixating the Sternum: Animal Testing
Earlier Bone Healing in Baboons
1
• 14 skeletally mature baboons underwent standard median sternotomy
• 7 closed w/ 24‐gauge wire circlage
• 7 closed with thin Vitallium compression miniplates & transverse lag screws
• Sternum harvested @ 4 & 8 weeks
• Clinical stability superior with plates @ 4 weeks
• Rigid fixation resulted in earlier union than wires
1)
Sargent, L. (1991). The Healing sternum: a comparison of osseous healing with wire versus rigid fixation. Ann of Thoracic Surgery, 52, 490‐494.
Earlier Bone Healing
1
¾ Histological evaluations of Manubrium @ 4 weeks post op in Baboons
¾ Evaluation by Sargeant (1991)
Non‐union with Wire
(the gap across the circlage wire manubrium shows little bone formation)
1)
Sargent, L. (1991). The Healing sternum: a comparison of osseous healing with wire versus rigid fixation. Ann of Thoracic Surgery, 52, 490‐494.
Bone Formation w/ Rigid Fixation
(primary bone formed across plated manubrium)
Rigid Fixation of the Sternum
Sternal Closure
Why have we not evolved to rigid bone fixation like other specialties? (neuro, ortho, spine, cmf)
Phalanges
Clavicle
Femur
Fibula
Rigid Fixation
Midface
Radius
Humerus
Spine
SternaLock® Technique
1
1) Sternotomy & bone assessment
2) Measure sternal depth & select screws
3) Reduce sternum
4) Select & contour plates
5) Fixate plates to sternum & complete chest closure
Sternotomy & Bone Assessment
I) Perform midline sternotomy
Notes:
* Ensure down center of sternum
* Use reference points to guide your cut
Reference Points for Sternotomy
II) Expose sternum by reflecting the pectoral muscle Pectoral Muscle
Sternum
III) Analyze the bone health
Notes:
* Consider risk factors that cause poor bone quality
* How did the bone feel when cut with saw
* Feel the bone with your fingers (solid or soft)
Examine Bone Quality
IV) Identify Transverse Fractures
Notes:
* Mark transverse fractures
* When closing do not place screws on / near fractures
Transverse Fractures
V) Carefully Retract the Sternum
Notes:
* Minimize trauma to sternum
* Apply even force along sternal halves to avoid fractures
Apply Even Force
V) Perform Intended Surgical Procedure
Notes:
* During procedure minimize trauma to sternum
3) Reduce sternum
Measure sternal depth & select screws
I) Measure Sternal Depth After Procedure
Notes:
* Measure at 3 Points (Manubrium, Body & Xiphoid)
* If additional plates used – measure depth at plate location
* Write down the measurements for later use
Measuring Depth of Sternum
Measure at 3 Locations on Sternum…
Manubrium
Xyphoid
Body
II) Select Screw Sizes Using Measurements
Notes:
* Sternal plate is 2mm thick, so must add 2mm & select screw
* Screw will penetrate bone up to the posterior cortex
* Short screws can lead to backout / Long screws can puncture
Use Screws that are 1‐2mm Longer than Sternal Depth
Examples of Various Screw Lengths…
Too Short
Just Right
Too Long
3) Reduce sternum
Reduce Sternum
I) Use Wires to Approximate Sternum
Notes:
* 2 Wires at Manubrium to approximate sternum
* 1 Wire at Xyphoid to approximate sternum
* Sternal halves aligned in lateral, AP and RC directions
* Ensure tight connection (cancellous to cancellous)
Wires @ Manubrium
Wires @ Xyphoid
Wires Pulling Sternum Together
Reduce Sternum
II) Use Reduction Forceps to Align Segments
Notes:
* Apply to inferior intercostal spaces to avoid internal mammary
* Do not apply too much force as it will damage the bone
Reduction Forceps Approximating Sternum
3) Reduce sternum
Select & Contour Plates
I) Select Plates To Implant
Notes:
* Determine the number of plates to place & location
* Ensure plates will have good space to rest on
* Recommend at least 5 “struts” across the sternotomy
* Do not place non‐cuttable sections across sternotomy
“L Plate” placed at Manubrium
“X Plate” placed at Body
“X Plate” placed at as low as possible
II) Clear Excess Tissue From the Bone
Notes:
* Mark where plates will rest with Bovie pen
* Use Bovie pen to remove excess tissue @ plate location
* Do not fully strip the periosteum – important for blood flow
Use Bovie pen to mark plate location & clear excess tissue
III) Contour Plates
Notes:
* Plates should rest flush to the bone – contour to achieve this
* Use plate benders to bend plate as necessary
* Bend each plate to conform to anatomy at site of implantation
Bending Plate to Contour to Anatomy
3) Reduce sternum
Fixate Plates & Complete Chest Closure
I) Fixate Plates to Sternum
Notes:
* Begin by inserting screw into outer holes – work your way in
* Hold plate flush to the bone while inserting screw
* Do not fully seat the first screw – plate will spin
Drive screw into plate keeping the screw as perpendicular as possible to plate
Examples of improperly fixated Plates…
II) Continue Fixating Plates Until Complete
Notes:
* Place the first plate at the body of the sternum
* Place the second plate as close to the Xyphoid as possible
* Place the final plate at the manubrium
Completely Fixated Sternum
If screws do not gain purchase use Emergency Screws…
2.7 mm Diameter (Emergency)
2.4 mm Diameter (Standard)
Red SternaLock® Emergency Screw
III) Complete Chest Closure
Closing the Chest
If necessary to re‐enter...
Option 1:
Cut Plate Cross‐Section with Double Action Wire Cutters
Or…
Option 2:
Use Screwdriver to Remove Screws
SternaLock® Technique Review
3) Reduce sternum
Proper Technique is Key!!
Fixating the Sternum: Clinical Study
RESTORE Study
1
• Randomized‐Controlled Multicenter Study to Evaluate STernotomy Patients for Osteosynthesis and REcovery
• 7 Sites
•Scott & White (Temple, TX)
•University of Chicago
•Baptist Memorial (Memphis, TN)
•Leipzig (Germany)
•Tampere University (Finland)
•UC Davis (CA)
•St. Joseph's (Phoenix, AZ)
• N=432; 216 observational (wire); 216 treatment (SternaLock)
• Primary endpoints: osteosynthesis, pain, return to activity score
• Follow‐up at baseline, days 0‐10, discharge, 3 wk, 6 wks, 3 mo, 6 mo
1)
A Prospective, randomized‐controlled, multicenter study evaluating primary plating in high‐risk median sternotomy patients for osteosynthesis and pain. (n.d.). Retrieved from http://clinicaltrials.gov/ct2/show/NCT00819286?term=sternalock&rank=1
Inclusion pre‐op (≥3)
•
•
•
•
•
•
•
•
•
•
COPD
Diabetes mellitus
BMI > 30 kg/m²
Osteoporosis
Renal failures
Chronic steroid use
Concurrent infection
Immunosupression
Redo sternotomy
Neurologic dysfunction
Inclusion intra‐op
• Bilateral IMA
• Cardio‐pulmonary bypass time > 2h
• Transverse fracture
• Off‐midline sternotomy
Exclusion
• No contract
• < 18 years
• Pregnant
• Lactation
• CCS Class IV
• NYHA Class IV
• Emergency
• Don’t come to the follow‐up
Drop out (n=7)
• 2x bleeding
• Pulmonary embolism
• 2x Bypass failure
• 2x Re mitral valve replacement
Patient (n= 60)
wire
plates
n
31
29
age
66.4 ±10 y
66.1 ±7 y
male
72.4 %
77.4 %
coronary HD
72.4%
61.3%
Risk factor
25
20
15
10
5
0
DM
COPD
BMI > 30
Wire
Osteoporose
NI
Sternalock
ReSternotomie
BIMA
Bypass Time
> 2h
Sternalock group
Wire group
singel wire
about periost
1x wire per 10 kg
min. 7 wire
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Ge
tiv
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ity
ho
ra
l F
le
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at
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e
w
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kn
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s
W
a
sle
ak
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ep
g u
p ni
Fe
gh
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t
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g s
lee
py
Ne
ck
Up
pa
pe
in
r b
ac
k p
Sh
ain
ou
lde
r p
ain
pa
pa
in
in
a
d
t r
ee
es
p b
t
pa
in
re
d
at
ur
hi
in
ng
g c
pa
ou
in
g
hi
d
ng
ur
in
te
g a
nd
ct
er
iv i
ne
ty
ss
/ i
rri
ta
tio
wo
n
un
d he
ali
Ne
ng
tin
ck
gli
st
ng
if f
ne
ch
ss
es
t
ch
in
es
c is
t i
io
nc
n
W
is i
or
o
ry
n
lo
in
g c
ok
Po
he
s
pp
st
in
op
g/
gr
en
at
in
in
g
g/
c l
ick
in
g
ly i
Activity after 3 month
2,50
(Somew2,00
hat)
Baseline
SternaLock
Wire
1,50
1,00
0,50
0,00
Wire
Baseline
Pain
40,00
38,68
36,71
35,00
33,21
31,78
30,00
30,37
28,96
26,42
25,00
27,14
26,05
26,48
24,16
20,00
19,48
15,96
15,00
21,96
26,23
22,68
23,14
23,10
22,25
22,18
19,69
25,38
27,71
26,44
23,07
21,24
20,78
20,36
10,00
5,00
0,00
Pre‐Op
Post‐ Op Post‐ Op
Baseline
Day 3
Day 4
Day 5
Day 6
Post‐ Op
Day 7
Post‐ Op Post‐Op
Day 8
Day 9
Day 10 Dischar Post‐ Op Post‐ Op
Post‐ Op
Week 3
Post‐ Op
Week 6
ge
Month 3
Month 6
Wire
SternaLock
CT Scan 3 month
CT scan 6 month
Infection
Wire
plates
superficial
1
1
medistinitis
0
0
Instable sternum
0
0
Conclusion
• More activity in first time after operation
• Less pain after operation
• No difference between infection
SternaLock® Case Studies
Thank you
sven.lehmann@med.uni‐leipzig.de