Controlled
Multy/monoplace
HBO
Professor Gösta Granström
Department of Otolaryngology,
Head and Neck Surgery
University of Gothenburg, Sweden
Address:
Sahlgrenska University Hospital
S-413 45 Gothenburg, Sweden
Tel: +46-31-3421276
Fax: +46-31-416734
E-mail: gosta.granstrom@orlss.gu.se
This protocol has been
adopted by the Working Group Oncology of COST action B14.
“This protocol
has been considered in detail, and accepted by COSTB14. This is a
multi-national group of experts in the field of Hyperbaric Medicine, appointed
nationally in each individual case, and organised and supported by the European
Commission. Thus, the work described has been subjected to extensive peer
review and amendment, and may be regarded as consistent with best practice in
the field of Hyperbaric Medicine”
COST B14 Working
Group Oncology:
DENMARK JANSEN
Erik C
POLAND SICKO
Zdzislaw
PORTUGAL SIMAO
Antonio
SWEDEN GRANSTRÖM
Gösta
SWITZERLAND SCHMUTZ Jorg
SMINIA Peter
UNITED KINGDOM HAMILTON-FARRELL
Martin H
Since
1965, an increasing number of patients have osseointegrated implants installed
in various parts of the skeleton. These implants were originally developed to
anchor dental bridges in edentulous patients. Since 1977, the concept has
spread outside the oral cavity, to be used among patients who have
malformations of the face, and tissue defects after cancer surgery or trauma.
Furthermore, patients who need amplification from a hearing aid due to a
conductive type of hearing loss can have a bone-anchored hearing aid attached
to an osseointegrated implant. There are also orthopaedic applications in that
amputees might have prostheses fastened on implants anchored in the extremities
or joint replacements based on the same concept. It is estimated that more than
3 million patients have had more than 10 million implants installed worldwide
since 1965, most of these for dental reasons.
Implant
survival depends on the region in which the implant is installed. The longest
follow-up reports exist for implants in the oral cavity. It is expected that
implants in the mandible may survive to more than 90% after 20 years. The
corresponding figure for the maxilla is 80%. Temporal bone implants remain in
place to 90% after 20 years, whereas implants in other parts of the
craniofacial skeleton are lost to a higher proportion.
It
is well known that compromised tissues have a reduced capacity to integrate and
maintain osseointegrated implants. Compromised tissues could appear after
surgery, burns, pharmacological treatment as chronic steroid treatment,
chemotherapy or after radiotherapy. The most common reason for a compromised
tissue among patients needing osseointegrated implants has been after
irradiation of malignant tumours (1).
From
experimental studies it is known that irradiated bone partly loses it’s
capacity to repair and new synthesise bone and mineralise the newly formed bone
(2). It thus would have a reduced capacity to accept osseointegrated implants.
HBO has in other experimental studies been shown to stimulate bone formation,
increase the bone turnover and especially bone maturation (3). It has also been
shown to improve osseointegration by increasing the bone-metal contact area,
the amount of bone inside the treads and to increase the removal torque
necessary to unscrew the implants (4).
In
clinical longitudinal studies implant failures have repeatedly been reported to
be higher if the patient has been irradiated prior to implant installation (5).
Several studies have also shown that adjunctive HBO might improve
osseointegration and thus reduce implant failures (6,7).
In
a recent debate in the U.S.A. these two statements have been questioned (8,9).
It has thus been stated that there is not a higher implant failure rate among
patients that have been irradiated to oral cancers and who have had
osseointegrated implants installed in the mandible. As a consequence there
would thus be no need for preventive measures using HBO.
If
such an attitude is spreading among clinicians, we would have to expect a
number of drawbacks from implant surgery in irradiated tissues as denuded bone,
dehiscence, infections, fistulation and ultimately osteoradionecrosis. In order
to get a better basis for judgement, a multicenter study designed to answer
these questions would be advocated.
To establish if osseointegrated implant failures are higher in previously irradiated tissues. To establish if HBO can be used to reduce implant failures in irradiated tissues.
Main
endpoint:
-
Survival of osseointegrated implants.
Secondary
endpoints:
-
Implant failure in relation to irradiation dose,
irradiation quality, time from irradiation to implant surgery
-
Implant failure in relation to anatomical region
-
Implant failure in relation to implant material
and design used.
Based
on data from reference (7) the expected difference between the study group and
control group after three year to be 80% (p<0.05); 48 participants (24 of
each group) would be needed. (Addendum 1).
Inclusion
criteria:
-
Patient needing osseointegrated implants in the
head and neck region that has been previously irradiated.
-
Patient treated at osseointegration clinic with
good relation to local HBO-centre and willing to report continuously data to
study centre.
-
Physical and psyhological fitness for HBO therapy.
-
Provision of written informed consent and
availability for follow-up.
Exclusion
criteria:
-
Patients with active cancer needing removal of
implants or other types of reconstruction, postoperative chemotherapy or
radiotherapy.
-
Previous HBO-therapy after cancer diagnosis.
-
Other contraindications according to HBO standards
Haemoglobin
Age
and gender
Implant surgery will be performed by the used standardised technique.
Type
of implant, length of fixture recorded
Abutment
type and length to be recorded
Region
of implant installation
Prosthetic
device recorded including anchorage to abutments.
Implant
survival at clinical follow-up recordings. These would be performed at three
months intervals during the first year, at six months intervals during the
following two years and thereafter at yearly follow-ups.
After
informed consent, patients will be randomised by study centre (Gothenburg) to HBO or not HBO.
According to randomisation, patients will receive an
oxygen treatment following one of two modalities:
-
HBO group:
20 HBO preoperatively (1 treatment per day, 5-7 days per
week) and 10 HBO postoperatively (with start no later than 3 days after
surgery), one treatment per day, 2.5 ATA, 100% O2, during 90
minutes. Accepted ranges will be 2.4 – 2.6 ATA, up to 10 min airbrakes will be
allowed every 30 minutes.
Treatments will be given in a multiplace hyperbaric
chamber, using a demand-system face mask or in a monoplace chamber.
-
non-HBO group:
No adjunctive treatment.
The
scientist making the statistical analysis will be unaware of the type of
treatment given to the patients.
Evaluation
of the patients will be performed on coded evaluation records, devoid of any
possible identification of the patient. All evaluation sets will be sent to a
central data gathering and analysis office.
Data
gathered will include
Clinical
stability of implants.
X-ray
recordings.
Mucosa
or skin adverse reactions.
Appropriate statistical analysis using Mantel's test (9) and Fisher's test for
paired comparisons (10).
1. Granström G, Tjellström A, Brånemark P-I,
Fornander J. Bone-anchored reconstruction of the irradiated head and neck
cancer patient. Otolaryngol Head Neck Surg 1993;108:334-343.
2. Jacobsson M, Nannmark U, Sennerby L. Acute
microvascular reactions to ionizing irradation in bone-anchored titanium
implants: a vital microscopic study. Int J Oral Maxillofac Impl 1987;2:193-196.
3. Johnsson K, Hansson Å, Granström G, Jacobsson M, Turesson I. The effect of HBO on bone-titanium implant interface strength with and without preceding irradiation. Int J Oral Maxillofac Impl. 1993;8:415-419.
4. Johnsson ÅA, Sawaii T, Jacobsson M,
Granström G. Turesson I. A histomorphometric study of bone reactions to
titanium implants in irradiated bone and the effect of hyperbaric oxygen
treatment. Int J Oral Maxillofac Impl 1999;14:699-706.
5. Granström G, Bergström K, Tjellström A,
Brånemark PI. A detailed study of titanium fixture implants lost in
irradiated tissues. Int J Oral Maxillofac Impl 1994:9:653-662.
6.
Granström G, Jacobsson M, Tjellström A. Titanium implants in the irradiated
tissue. Benefits from hyperbaric oxygen. Int. J. Oral Maxillofac. Impl.
1992;7;15-25.
7. Granström G, Tjellström A, Brånemark, P-I. Osseointegrated
implants in irradiated bone. A case-controlled study using adjunctive
hyperbaric oxygen therapy. J Oral Maxillofac Surg 1999;57:493-499.
8.
Larsen PE: Placement of Dental Implants in the irradiated mandible: A protocol
involving adjunctive hyperbaric oxygen. J Oral Maxillofac Surg 1997;55:967-971.
9. Keller EE: Placement of dental implants in the irradiated
mandible: A protocol without adjunctive hyperbaric oxygen. J Oral Maxillofac Surg
1997;55:972-980.
10. Mantel N: Ranking procedures for arbitrarely restricted observations. Biometrics 1967;23:65.
11.
Bradley JW: Distribution-free statistical tests. London, Prentics-Hall, 1968,
p68.
The
study is pending on approval from the local ethics committee.
Patient entry protocol 1 (this space for study centre only)
Centre code Patient code Date
Sex M F Age_____
Patient entry is reported
from
Doctor (name)
___________________________________________________________________
Clinic___________________________________________________________________________
Address
_________________________________________________________________________
Telephone _____________________________Fax_______________________________________
E-mail___________________________________________
Which is: tick
corresponding below
Surgical clinic: qOral surgery qMaxillofacial surgery qENT surgery qOther (specify)
Prosthetic
clinic: qProsthodontic qAnaplastology qOther (specify)
HBO-clinic: qMultiplace facilityqMonoplace facility qOther
Patient name only for your own records, not for study center
Family name____________________________First name_______________________________
Social
security number or corresponding____________________________________________
Patient entry protocol 2 (this space for study centre only)
Centre code Patient code Date
Patient
history of relevance
_______________________________________________________________________________
Cancer
treatment
Type
of cancer_________________Site____________________Differentiation______________
Date
of diagnosis qqqqqq (yymmdd)
Surgery,
What type_______________________________________________________________
Date
of surgery qqqqqq (yymmdd)
Radiotherapy, Type___________________________Fractionation________________________
Dose________________________________________Region__________________________
Start
of rt qqqqqq (yymmdd) End of rt qqqqqq (yymmdd)
Chemotherapy, qYes qNo
Type_______________Dose___________________Interval___________________________
Type_______________Dose___________________Interval___________________________
Type_______________Dose___________________Interval__________________________
Type_______________Dose___________________Interval___________________________
Is the patient clinically tumour free? qYes qNo
If no, excluded from further participation___________________________________________
This note only for your own records, not for study center:
Patient randomised to A. qHBO B. qNo
adjunctive treatment
C. qControl (no radiotherapy given)
Patient entry protocol 3 (this space for study centre only)
Centre code Patient code Date
Fixture surgery
performed qqqqqq (yymmdd)
Preoperative x-ray qYes qNo What
type?________________________________________
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Fixture Surgery |
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Fixture n:o |
Type |
Length (mm) |
Region |
Primary stability |
Special remarks |
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Postoperative x-ray qYes qNo What
type?________________________________________
Patient follow-up is
reported from
Doctor (name)
___________________________________________________________________
Clinic_______________________________________________________________________
Address
________________________________________________________________________
Telephone ____________________Fax____ _ ___
E-mail____________________________________
Patient entry protocol 4 (this space for study centre only)
Centre code Patient code Date
Abutment surgery
performed qqqqqq (yymmdd)
Preoperative x-ray qYes qNo What type?________________________________________
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Abutment Surgery |
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Abutment n:o |
Type |
Length (mm) |
Region |
Special remarks |
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Postoperative x-ray qYes qNo What type?________________________________________
Make a simple sketch of the
fixture site and abutment connection here
Patient entry protocol 5 (this space for study centre only)
Centre code Patient code Date
Prosthetic reconstruction
performed qqqqqq (yymmdd)
Preprosthetic x-ray qYes qNo What
type?________________________________________
Prosthetic
device_________________________________________________________________
Anchorage
by____________________________________________________________________
Type of
retention_________________________________________________________________
On how many of the abutments
is the device anchored_________________________________
Open or closed tumour cavity______________________________________________________
Other variables
(specify)__________________________________________________________
________________________________________________________________________________
Patient entry protocol 6 (this space for study centre only)
Centre code Patient code Date
Study Group A
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HBO PROTOCOL |
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Date |
kPa |
Length (min.) |
No. of O2 periods |
Length of each O2
period (min.) |
no. of air intervals |
Length of each air
interval (min.) |
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Patient entry protocol 7 (this space for study centre only)
Centre code Patient code Date
Study Group
B
No adjunctive treatment
Comments:
Patient entry protocol 7 (this space for study centre only)
Centre code Patient code Date
Study Group
C
Control group,
non-irradiated patients
Comments:
Patient report protocol 1 (this space for study centre only)
Centre code Patient code Date
Clinical follow up, q
months after abutment surgery qqqqqq (yymmdd)
Control x-ray qYes qNo What
type?________________________________________
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Follow-up protocol |
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Implant
n:o |
Fixture stable? |
Abutment stable? |
Skin/mucosa reactions
grade* |
Special remarks |
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*Skin/mucosa reactions: 0=reaction free; 1=red; 2=red and moist; 3= granulation; 4=infection making removal of abutment necessary
Patient report protocol 2 (this space for study centre only)
Centre code Patient code Date
Clinical follow up, q
months after abutment surgery qqqqqq (yymmdd)
Control x-ray qYes qNo What
type?________________________________________
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Follow-up protocol |
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Implant
n:o |
Fixture stable? |
Abutment stable? |
Skin/mucosa reactions
grade* |
Special remarks |
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*Skin/mucosa reactions: 0=reaction free; 1=red; 2=red and moist; 3= granulation; 4=infection making removal of abutment necessary
Patient report protocol 3 (this space for study centre only)
Centre code Patient code Date
Clinical follow up, q
months after abutment surgery qqqqqq (yymmdd)
Control x-ray qYes qNo What
type?________________________________________
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Follow-up protocol |
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Implant
n:o |
Fixture stable? |
Abutment stable? |
Skin/mucosa reactions
grade* |
Special remarks |
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Patient report protocol 4 (this space for study centre only)
Centre code Patient code Date
Clinical follow up, q
months after abutment surgery qqqqqq (yymmdd)
Control x-ray qYes qNo What
type?________________________________________
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Follow-up protocol |
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Implant
n:o |
Fixture stable? |
Abutment stable? |
Skin/mucosa reactions
grade* |
Special remarks |
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Patient report protocol 5 (this space for study centre only)
Centre code Patient code Date
Clinical follow up, q
months after abutment surgery qqqqqq (yymmdd)
Control x-ray qYes qNo What
type?________________________________________
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Follow-up protocol |
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Implant
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Abutment stable? |
Skin/mucosa reactions
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Special remarks |
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Patient report protocol 6 (this space for study centre only)
Centre code Patient code Date
Clinical follow up, q
months after abutment surgery qqqqqq (yymmdd)
Control x-ray qYes qNo What
type?________________________________________
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Follow-up protocol |
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Abutment stable? |
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Special remarks |
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Patient report protocol 7 (this space for study centre only)
Centre code Patient code Date
Clinical follow up, q
months after abutment surgery qqqqqq (yymmdd)
Control x-ray qYes qNo What
type?________________________________________
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Follow-up protocol |
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Implant
n:o |
Fixture stable? |
Abutment stable? |
Skin/mucosa reactions
grade* |
Special remarks |
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0=reaction free; 1=red; 2=red and moist; 3= granulation; 4=infection making
removal of abutment necessary
Patient report protocol 8 (this space for study centre only)
Centre code Patient code Date
Clinical follow up, q
months after abutment surgery qqqqqq (yymmdd)
Control x-ray qYes qNo What
type?________________________________________
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Follow-up protocol |
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Implant
n:o |
Fixture stable? |
Abutment stable? |
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grade* |
Special remarks |
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* Skin/mucosa reactions: 0=reaction free; 1=red; 2=red and moist; 3= granulation; 4=infection making removal of abutment necessary
Patient report protocol 9 (this space for study centre only)
Centre code Patient code Date
Clinical follow up, q
months after abutment surgery qqqqqq (yymmdd)
Control x-ray qYes qNo What
type?________________________________________
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Follow-up protocol |
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Implant
n:o |
Fixture stable? |
Abutment stable? |
Skin/mucosa reactions
grade* |
Special remarks |
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* Skin/mucosa reactions: 0=reaction free; 1=red; 2=red and moist; 3= granulation; 4=infection making removal of abutment necessary
Patient report protocol 10 (this space for study centre only)
Centre code Patient code Date
Clinical follow up, q
months after abutment surgery qqqqqq (yymmdd)
Control x-ray qYes qNo What
type?________________________________________
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Follow-up protocol |
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Implant
n:o |
Fixture stable? |
Abutment stable? |
Skin/mucosa reactions
grade* |
Special remarks |
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*Skin/mucosa reactions: 0=reaction free; 1=red; 2=red and moist; 3= granulation; 4=infection making removal of abutment necessary
Patient report protocol 11 (this space for study centre only)
Centre code Patient code Date
Bästa patient.
Inför din operation då titanimplantat skall opereras in har du
erbjudits att delta i en studie för att utvärdera om strålbehandling
påverkar implantatens framtida funktion. Om du accepterar att delta i
studien kommer du att lottas att antingen ingå i en grupp av patienter
som får tryckkammarbehandling innan operationen. Den andra gruppen patienter
får ingen speciell förbehandling.
Behandlingen
i tryckkammare innebär att man får 20 behandlingar med syrgas under tryck
före operationen och 10 behandlingar efter implantatoperationen. Syrgas har i
experimentella studier visats kunna fungera som tillväxtfaktor för ben vilket
skulle kunna förbättra det framtida fästet för implantaten. Varje behandling
tar drygt två timmar i anspråk och sker i den tryckkammare som
finns närmast din bostadsort. Behandlingen
är kostnadsfri. Inför behandlingen behöver du genomföra en lungröntgen vilken
måste vara normal för att behandlingen skall kunna genomföras.
Om
du accepterar att delta i studien kommer du om du lottas att delta i tryckkammargruppen,
att kallas för ett speciellt besök vid tryckkammaren för att få se hur
behandlingen praktiskt går till väga, få information om hur den
genomförs och en individuell behandlingsplan kommer då att läggas upp för
dig.
Deltagande
i studien är helt frivilligt och kan avbrytas närhelst du så önskar utan
att något speciellt skäl för detta behöver anges.
Jag
har tagit del av ovanstående information, förstått innehållet
och accepterar att delta i studien
Ort…………………………………..Datum…………………………
………………………………………………………………………………
Namnteckning
Namnförtydligande
Huvudansvarig
för studien är professor Gösta Granström, Avdelningen för ÖNH-sjukdomar,
Göteborgs Universitet tel 031-3421000
Patient report protocol 11 (this space for study centre only)
Centre code Patient code Date
Before your planned surgical procedure when you will have titanium
implants installed, your may wish to participate in a study which is being
conducted to evaluate if radiotherapy affects the long-term survival of
implants. If you accept to participate in the study, you will be selected to
participate either in a group of patients who will be given hyperbaric oxygen
therapy before surgery or in a group of patients will have no special treatment
before surgery.
Hyperbaric oxygen treatment will mean 20 preoperative oxygen treatments
in a chamber compressed with air and 10 postoperative treatments. Oxygen has in
experimental studies been shown to function similarly as growth factors for
bone which might improve the outcome of the implants. Each treatment takes
approximately two hours and will be conducted at the hyperbaric chamber nearest
to where you live.
If you
accept to participate, and if you are selected for hyperbaric oxygen treatment,
you will called to the hyperbaric chamber for practical information of how the
treatment will be conducted, and an individual treatment plan for you will be
put forward.
Participation
in the study is voluntary and can be stopped whenever you wish without giving
any reason.
I have
read the above information, understood the content and accept to participate in
the study.
Place…………………………………..Date…………………………
………………………………………………………………………………
Signature
Name
The study director is professor Gösta Granström,
Department of Otolaryngology, Göteborg University, Sweden phone: +46-31-3421000
Patient report protocol 12 (this space for study centre only)
Centre code Patient code Date
ADVERSE AND SIDE EFFECTS FORM