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DIANA
For
Case no.
Statutory health insurance or cost bearer
7. What your doctor needs to know...
Surname, first name of the insured party
The risk of medical interventions is affected by your physical
health and any pre-existing medical conditions. So that we can
identify potential problems before the surgery, please answer the
following questions:
Date of birth
Insurer no.
DIANA
Insured party no.
Status
As with every surgical procedure and despite taking all possible
care, incidents may occur, particularly involving injury to nearby
tissues. The risk of damage of this kind occurring depends first
and foremost on the bone quality and your individual anatomy,
both of which will be assessed by appropriate imaging before the
operation. The following complications are possible:
During the operation:
1. Do you know if you have any metabolic disorders (e.g.,
diabetes) or disorders of major organs (blood circulation,
heart, kidneys, liver, lungs, thyroid, nervous system)?
No
SHI-accredited physician no.
4. What are the possible complications?
■ The implant may be incorrectly positioned.
■ Blood vessels, particularly the large blood vessels in the pelvic
Yes. Please provide details
cavity, may be injured, leading to heavy bleeding that needs
a blood transfusion. In extremely rare cases, transfusion of
blood or blood constituents can result in an infection with,
for example, hepatitis viruses (inflammation of the liver), HIV
(AIDS) and / or other pathogens.
Health ins. card valid until Date
Practice / Clinic / Hospital / Institution (stamp):
Please observe the following guidelines for
follow-up treatment which your doctor will
discuss with you before you are discharged
from hospital:
■ Before you are discharged from the hospital, you need to
practice using the walking aids with the help of your physical
therapist as well as partial weight-bearing on the leg on the
operated side with a maximum of 20kg.
■ Increase the weight slowly.
■ Avoid any sexual activity during the partial weight-bearing
2. Do you have an infectious disease (e.g., hepatitis, AIDS)?
No
Yes. Please provide details
■ Nerves may be injured, which can lead to temporary or
permanent partial paralysis and / or impaired sensation
(numbness, odd sensations), for example, of the leg or both
legs.
3. Do you have any allergies or hypersensitivity reactions, (e.g.,
against adhesive dressings, latex, medicines, skin
disinfectants, foods) or metal (e.g., nickel)?
No
■ Nerves and soft tissue may be damaged because of pressure
caused by the position of your body during surgery; this
damage is usually temporary but in isolated cases the
symptoms (e.g., numbness, odd sensations) or scars may
persist. This is also true of damage to the skin caused by
disinfectants and / or electric current.
Yes
4. Have you had heavy bleeding or blood loss during previous
operations (e.g., dental treatment)?
No
■ Fat or bone marrow embolism: fatty tissue and / or bone
Yes
marrow tissue may enter the blood circulation and be carried
into the lungs where it causes life-threatening circulatory
disorders (e.g., lung embolism) or permanent damage to
organs or heart attack. Embolisms require immediate
intensive care treatment.
phase.
■ You must not play sport or undergo any physical therapy for
6 months after your surgery. Make sure when you start
physical therapy that your therapist is familiar with the DIANA
procedure!
5. Have you ever had an operation on your spine, pelvis, or
hips?
No
Yes. Please provide details
■ Allergic reactions to disinfectants, glues, latex, or drugs, such
as antibiotics, with subsequent swelling, reddening, and / or
itching. In very rare cases, life-threatening circulatory
reactions can occur (shock). These require intensive care
treatment. If insufficient blood flows through the organs in
such situations, this can lead to permanent damage (e.g.,
kidney failure, brain damage, seizures).
■ Avoid falls.
■ Always pay attention to the instructions given to you by your
doctor.
You will usually need to visit your surgeon to monitor your healing
process and have X-rays and CT scans taken.
Please let your doctor know immediately if you feel any pain, if
you develop any bladder or bowel problems, or if you have difficulties moving or notice a change in sensations in your buttocks
or legs, even if these symptoms seem insignificant to you. These
symptoms can be a sign of impaired blood circulation or nerve
disorders that must be treated immediately.
If you have any questions regarding the healing process, please
contact your doctor after the operation.
Have you experienced pus formation, delayed healing,
abscesses, fistulas or severe scarring with previous wounds?
No
Yes
6. Have you developed blood clots or have any clots moved in
your body (e.g. thrombosis, embolism)?
No
After the operation:
In isolated cases, disorders or delayed effects can develop. Postoperative bleeding and bruising that require surgical treatment.
Yes
7. Do you regularly take medicines such as heart medication,
painkillers, anticoagulants (e.g., warfarin, phenprocoumon,
aspirin), or hormones (e.g., the contraceptive pill)?
No
■ Thromboembolism: Bedridden patients in particular can
Yes. Please provide details
In the surgical consultation, you should ask about everything
that seems important to you (e.g., urgency of the intervention,
chances of success). Note down your questions on a separate
sheet of paper to make it easier to remember them during your
discussion with the doctor.
Rev. 2015-09 / 03
6. Questions for your surgical consultation
develop blood clots in the veins of the legs or pelvis
(thrombosis). These can travel into the lungs where they cause
life-threatening circulatory disturbances (embolism). Smokers
and people taking medications (e.g., hormone preparations)
have a higher risk of developing thromboembolism. For as
long as you are at risk, you will receive medication to reduce
blood clotting (thrombosis prophylaxis). However, these
medicines also increase the tendency to bleed.
■ Infections around the surgical site: Despite the precautionary
measures taken, inflammations may develop along the
surgical access route. In rare cases, inflammation can lead to
chronic bone abscess (= osteitis), and in extremely rare and
exceptional cases to germs entering the blood stream
(= sepsis).
■ Excessive and troublesome scars (= keloid) which can develop
in people with a corresponding predisposition or following a
wound infection.
■ Loosening of the implant leading to the formation of a false
joint (= pseudarthrosis) if the healing process is delayed and
not enough new bone substance is formed. Special measures
(e.g., another surgical procedure) must then be taken, about
which you will be informed separately.
■ Spontaneous fractures of the sacrum or the iliac wing.
■ Longer term, persistent pain in some cases; procedure fails to
bring about the expected outcome.
Most of the complications listed may require follow-up surgery.
If follow-up surgery is required, the implant may need to be
removed or replaced by a larger one using the same access
without damaging anatomic structures.
For women of childbearing age who wish to have children, you
should consult a gynecologist who can advise you about your
individual pelvic anatomy and, if applicable, the need for delivery
by cesarean section. The reason for this is that fusion of the SIJ can
theoretically lead to problems during a vaginal delivery so that
cesarean section may become necessary. In cases known to date
of pregnancy after DIANA implantation, there were no problems
during the pregnancies or the deliveries.
PATIENT INFORMATION
Stabilizing Operation on the Sacroiliac Joint –
Distraction Arthrodesis DIANA
Dear Patient,
Your treating physician has diagnosed a painful disorder of
your sacroiliac joint that needs surgical treatment. Before the
operation, your doctor will discuss with you the need for the
treatment and the treatment options. You should know about the
risks and consequences of the planned procedure and also about
alternatives to this treatment so that you can make a decision and
consent to the procedure. This information sheet will help you
prepare for the surgical consultation with the doctor and give you
information about the most important aspects of the operation.
Front view
Rear view
5th lumbar
vertebra (L5)
Recess
DIANA implant
Recess
Iliac bone
Sacroiliac joint
5. What do you have to watch out for?
Sacral bone
■ The bone material inserted into the joint needs time to heal;
the side that has been treated must carry only part of your
weight for 8 weeks after the operation (walking aids on both
sides). You need to take anti-thrombotic medication during
this period. Your doctor will discuss this medication with you.
Sudden, jerky twisting of the body, bending down, lifting
heavy objects, and sport should be avoided if possible for
another 12–16 weeks. If the healing process is normal, there
are usually no restrictions on the stresses placed on your SIJ
after this period.
Acetabulum
Symphysis
Fig. 1: Views of the pelvis
The sacroiliac joint
■ You can sit from the first day after surgery.
■ The implant is made from a titanium alloy that is well
tolerated by the body and does not have to be removed.
The pelvis is a bony ring made up of the sacrum, ilium, ischium,
and pubic bones and joins at the front of the body at the pubic
symphysis. The joint between the sacrum and the ilium, which
is called the sacroiliac joint (SIJ), is located between the sacrum
in the center of the body and the left and right iliac bones. This
means that there is a left and a right SIJ. The joint has a curved
shape (Fig. 4) with two surfaces covered with cartilage and a joint
capsule.
Both sacroiliac joints are also
surrounded by a system of
strong ligaments, as is the
entire pelvic girdle. These
ligament structures mean that
the SIJ only has a very small
range of motion compared
to other joints in our body.
Although in adults the joint
only moves by a few degrees,
it plays an important role in Fig. 2: Movement of forces through
nearly all normal physical the sacroiliac joints
activity. Almost all the forces
moving between the upper and lower half of the body are transmitted through the sacroiliac joints.
Like all other joints in the human body, the sacroiliac joint can
sooner or later develop osteoarthritis (= wear and tear of the joint
surfaces).
Fig. 3: Left = normal joint situation, right = osteoarthritis
While in babies the joint surfaces of the SIJ are almost completely
smooth, in adults they have an irregular shape which differs
from individual to individual (Fig. 4). Both joint surfaces are
nevertheless fully congruent (i.e., they fit each other perfectly)
in adulthood. However, this congruence can be lost for various
reasons (e.g., following pregnancy), causing the joint to wear out
prematurely.
DIANA
Basically, treatment of painful disorders of the sacroiliac joint is
divided into two types:
■ Conservative treatments such as oral painkillers, physical
therapy, chiropractic therapy, stabilization using a special
corset, injections into the joint or denervation treatments
(radiofrequency ablation or cryodenervation) to severe the
nerves traveling from the joint that conduct the pain signals.
■ Surgical therapy, which should only be considered once
conservative measures have proven unsuccessful: indirect
fusion of the bones in the joint using the DIANA technique.
The name of the procedure is based on its underlying concept:
DIANA = Distraction-Interference-Arthrodesis with Neurovascular (nerve and blood vessel-related) Anticipation.
Fig. 4: Varying shape and surface contours of the sacroiliac joints (based
on van Winderden and Vleeming)
Irregular bony connections between the sacrum and the ilium,
which are called accessory joints, are another cause of persistent
symptoms. These bony “virtual” connections develop while the
body is growing and in most cases only become symptomatic or
start causing pain in mid-life.
Previous fusion surgery on the lumbar spine can also increase
the pressure placed on the two sacroiliac joints. This increased
pressure can lead to the development of early painful osteoarthritis or it can cause existing osteoarthritis to suddenly start
causing pain.
Fractures of the pelvis that involve an injury to the sacroiliac joint
can also lead to early painful osteoarthritis of the SIJ, even after
adequate surgical stabilization (e.g., using a screw connection)
and complete healing of the bones.
In more rare cases, spondyloarthropathy (= chronic inflammatory
rheumatic disease of the spine), such as ankylosing spondylitis
(= Bechterew’s disease), can cause painful inflammatory changes
in the sacroiliac joints (sacroiliitis).
Symptoms
Pain in the sacroiliac joint is often referred to as SIJ syndrome,
sacralgia, or sacroiliitis. The pain can be chronic or acute. Current
studies estimate that SIJ syndrome accounts for more than 20%
of all cases of lower back pain. Chronic SIJ pain is felt around
the buttocks and sometimes also around the groin (blue area).
Discomfort when sitting, which can lead to a one-sided sitting
posture, can often be observed. Pain radiating down into the leg
on the same side as the affected
SIJ is also fairly common and is
similar to that caused by a slipped
disc.
The joint is accessed from the back (= posteriorly), similar to
the method used for lumbar intervertebral disc surgery but
without opening up the vertebral canal, so that the risk of
injuring important nerves and blood vessels or pelvic organs
can be all but ruled out.
Some of the questions most frequently asked by patients are
answered below to help you better understand the DIANA surgical
technique:
Should every patient who has pain in the sacroiliac
joint be helped with this procedure?
No. The gold standard is and will continue to be conservative
treatment of the sacroiliac joint, and conservative options
should be used as long as you experience significant relief
of your symptoms. However, if you have been using conservative therapy for months or years and the periods with limited
pain have become progressively shorter and you are starting
to take more medication to treat your symptoms, you should
consider an operation using the DIANA procedure if you have
the appropriate diagnosis.
What is an “interference screw”?
Latin: inter = between, ferire = to strike | to strike among or
between. In the DIANA procedure, an interference implant with a
special thread is fixed in place between the bony surfaces of the
sacrum and the ilium, which differ in their hardness, to keep the
articulating or moving surfaces of the sacroiliac joint apart until
indirect bony fusion (= complete healing) has taken place. This
separates the painful joint surfaces from each other while also
creating tension in the ligament system of the pelvic girdle that is
about the same as before the disease started.
Is it really enough to use the procedure only on one
side in cases of instability and bilateral osteoarthritis?
Your surgeon will only know if treating one sacroiliac joint is
enough after carrying out surgery on one side. The more painful
of the two joints is always treated first. In most cases, symptoms
on the side that has not been treated will also improve. If there is
no improvement on the other side, then it must be treated later
but only after the first side has healed completely. Because the
weight on the operated side must be limited to a maximum of
20kg body weight by using walking aids for a period of 8 weeks,
it is not possible to operate on both sides in one session.
Declaration of Informed Consent
8. For women of childbearing age:
is it possible that you could be pregnant?
No
Fig. 5: Access route and skin / muscle incisions
Is it likely with fusion of the sacroiliac joints that
attached structures (intervertebral discs, intervertebral
joints [= facet joints]) will be exposed to increased
stress and be worn out even earlier?
This theory is possibly true because this phenomenon has
been observed in association with fusion operations of the
spine. However, problems after surgery that are associated
with this procedure have not yet been confirmed.
Possible complications and comments
about the surgical consultation
1. How is the DIANA operation carried out?
The planned operation is done under general anesthesia (the
anesthetist will inform you separately about the details and
risks of the anesthetic procedure).
You will be placed on your stomach and an incision about
4–8cm (1.5–3 inches) long will be made along the midline of
your back. The connective tissue sheath (= fascia) of the long
muscles of the back is then exposed and opened up to access
the space behind the sacroiliac joint, which is called the recess
(Fig. 5). To do this, the ilium and the side of the sacrum in the
access area are exposed by carefully pushing aside the muscles
and ligaments. The recess is then thoroughly prepared using
surgical instruments. The stabilizing operation is performed
using a tapered implant that has self-cutting threads at the
front to screw it into the recess (Fig. 6). This process is called
distraction arthrodesis and is used to bring tension into the
ligament system to about the same level as before the disease
started so that the bony structures are stabilized. This stabilization ensures that the joint is immobilized, ensuring that the
additional bone material placed inside the recess has enough
time to grow into the bone.
Yes
9. Do you smoke?
No
Yes. Please indicate how many cigarettes
you smoke each day / week
Doctor’s comments on the surgical
consultation
Fig. 6: Position of the DIANA implant
2. Bone material
As mentioned above, the DIANA implant corrects the position of the
sacroiliac joint and temporarily immobilizes the joint. To achieve
the actual main objective of the operation, which is indirect fusion
(= arthrodesis) that results in permanent immobilization of the
joint, additional bone material must be inserted. To do this,
your surgeon will use bone material harvested from another
part of your body and / or bone graft substitute material, which
can be either of biological origin or synthetic.
During a surgical consultation with
(e.g., individual risks and associated possible complications;
specific questions asked by the patient; auxiliary interventions or
extension of the intervention; follow-up measures; problems that
may develop if the patient refuses / defers the treatment; limited
consent, e.g., regarding blood transfusion; person requiring care)
I was informed in detail about the planned operation as well as
about extensions to the procedure that may become necessary.
I have also been given enough information about alternative
treatment options.
During the consultation, I was able to ask all the questions that
I feel are important to me about the nature and significance of the
surgery, the risks associated with the surgery, and any additional
and follow-up procedures and the risks associated with these.
I / we do not have any more questions and have been given
enough information, and so I / we consent to the planned
operation having had enough time to think about my / our
decision.
I / we also consent to an unforeseeable, necessary extension to the
surgical procedure.
My / our consent also applies to the transfusion of blood or blood
constituents if this becomes necessary.
I have had the various bone substitute materials explained to me
and consent to the use of the following materials:
■ Autologous (harvested from my own body)
■ Allogeneic (donor bone)
■ Synthetic
■ Your own bone harvested from a suitable site.
Place / Date
■ Sterile donor bone.
■ Synthetic bone graft substitute material.
3. Extension of the procedure?
If you have had a stabilizing operation on your spine in
the past that reaches as far as the sacrum, then it may be
necessary to remove parts of the implants. If your surgeon
expects the planned procedure to be extended, then he or she
will inform you separately about the benefits and drawbacks
as well as the possible risks and long-term consequences
associated with the additional measures.
Patient’s signature
Refusal to consent the surgery
Place / Date / Duration of consultation
The suggested operation was refused after detailed information
had been provided. The patient was given information about
possible problems that may develop as a result of the refusal.
Place / Date
Doctor’s signature
Practice / Clinic / Hospital / Institution (stamp):
Signature of the patient / the legal guardian where required
Rev. 2015-09 / 03
Treatment options
PATIENT INFORMATION