010607

 

Final Protocol

 

 

OSSEOINTEGRATION IN IRRADIATED PATIENTS. ADJUNCTIVE HBO TO PREVENT IMPLANT FAILURES.

 

 

 

KEY WORDS:             Multicenter study

                                    Randomised

                                                Controlled

                                    Single-blinded

                                                Multy/monoplace HBO

                                    Preventive

 

 

Study Centre

 

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

GERMANY                                                                 CARL Ulrich M

POLAND                                SICKO Zdzislaw

PORTUGAL                            SIMAO Antonio

SWEDEN                                GRANSTRÖM Gösta

SWITZERLAND                                             SCHMUTZ Jorg

THE NETHERLANDS                                                       VAN DER KLEIJ Ad J

                                                SMINIA Peter

UNITED KINGDOM                              HAMILTON-FARRELL Martin H

1.      Background

 

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.

 

2.      Objectives

 

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.

 

3.      Study population

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

 

4.      Enrolment of participants

 

4.a. Baseline examinations

 

Clinical examination:

Clinical oral or ENT examination or corresponding

 

Laboratory investigations:

Haemoglobin

 

Paraclinical examinations:

Standard X-ray, tomography or computed tomography of region for implant installation

Skin or mucosa status at implant site

 

4.b. Baseline data recordings

 

Personal data:

Age and gender

Previous history of disease

History of malignancy, tumour surgery and irradiation protocols

 

Clinical data on osseointegration

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.

 

5.      Randomisation

 

After informed consent, patients will be randomised by study centre (Gothenburg) to HBO or not HBO.

 

6.      Intervention

 

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.

 

7.      Blinding

 

The scientist making the statistical analysis will be unaware of the type of treatment given to the patients.

 

8.      Evaluation

 

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.

 

9.      Data analysis

Appropriate statistical analysis using Mantel's test (9) and Fisher's test for paired comparisons (10).

10.     References

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          

 

 

PATIENT DATA

 

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?________________________________________

 

 

Fixture Surgery

Fixture n:o

Type

Length (mm)

Region

Primary stability

Special remarks

1

 

 

 

 

 

2

 

 

 

 

 

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12

 

 

 

 

 

 

 

 

 

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?________________________________________

 

 

Abutment Surgery

Abutment n:o

Type

Length (mm)

Region

Special remarks

1

 

 

 

 

2

 

 

 

 

3

 

 

 

 

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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

 

HBO PROTOCOL

Day

Date

kPa

Length (min.)

No. of  O2 periods

Length of each O2 period (min.)

no. of air intervals

Length of each air interval (min.)

1

 

 

 

 

 

 

 

2

 

 

 

 

 

 

 

3

 

 

 

 

 

 

 

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18

 

 

 

 

 

 

 

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20

 

 

 

 

 

 

 

Surgery

 

 

 

 

 

 

 

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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?________________________________________

 

Follow-up protocol

 

Implant n:o

Fixture stable?

Abutment stable?

Skin/mucosa reactions grade*

Special remarks

1

 

 

 

 

2

 

 

 

 

3

 

 

 

 

4

 

 

 

 

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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?________________________________________

 

Follow-up protocol

 

Implant n:o

Fixture stable?

Abutment stable?

Skin/mucosa reactions grade*

Special remarks

1

 

 

 

 

2

 

 

 

 

3

 

 

 

 

4

 

 

 

 

5

 

 

 

 

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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?________________________________________

 

Follow-up protocol

 

Implant n:o

Fixture stable?

Abutment stable?

Skin/mucosa reactions grade*

Special remarks

1

 

 

 

 

2

 

 

 

 

3

 

 

 

 

4

 

 

 

 

5

 

 

 

 

6

 

 

 

 

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9

 

 

 

 

10

 

 

 

 

11

 

 

 

 

12

 

 

 

 

 

* Skin/mucosa reactions: 0=reaction free; 1=red; 2=red and moist; 3= granulation; 4=infection making removal of abutment necessary

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

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?________________________________________

 

Follow-up protocol

 

Implant n:o

Fixture stable?

Abutment stable?

Skin/mucosa reactions grade*

Special remarks

1

 

 

 

 

2

 

 

 

 

3

 

 

 

 

4

 

 

 

 

5

 

 

 

 

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10

 

 

 

 

11

 

 

 

 

12

 

 

 

 

 

* Skin/mucosa reactions: 0=reaction free; 1=red; 2=red and moist; 3= granulation; 4=infection making removal of abutment necessary

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

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?________________________________________

 

Follow-up protocol

 

Implant n:o

Fixture stable?

Abutment stable?

Skin/mucosa reactions grade*

Special remarks

1

 

 

 

 

2

 

 

 

 

3

 

 

 

 

4

 

 

 

 

5

 

 

 

 

6

 

 

 

 

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8

 

 

 

 

9

 

 

 

 

10

 

 

 

 

11

 

 

 

 

12

 

 

 

 

 

* Skin/mucosa reactions: 0=reaction free; 1=red; 2=red and moist; 3= granulation; 4=infection making removal of abutment necessary

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

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?________________________________________

 

Follow-up protocol

 

Implant n:o

Fixture stable?

Abutment stable?

Skin/mucosa reactions grade*

Special remarks

1

 

 

 

 

2

 

 

 

 

3

 

 

 

 

4

 

 

 

 

5

 

 

 

 

6

 

 

 

 

7

 

 

 

 

8

 

 

 

 

9

 

 

 

 

10

 

 

 

 

11

 

 

 

 

12

 

 

 

 

 

* Skin/mucosa reactions: 0=reaction free; 1=red; 2=red and moist; 3= granulation; 4=infection making removal of abutment necessary

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

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?________________________________________

 

Follow-up protocol

 

Implant n:o

Fixture stable?

Abutment stable?

Skin/mucosa reactions grade*

Special remarks

1

 

 

 

 

2

 

 

 

 

3

 

 

 

 

4

 

 

 

 

5

 

 

 

 

6

 

 

 

 

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8

 

 

 

 

9

 

 

 

 

10

 

 

 

 

11

 

 

 

 

12

 

 

 

 

 

* Skin/mucosa reactions: 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?________________________________________

 

Follow-up protocol

 

Implant n:o

Fixture stable?

Abutment stable?

Skin/mucosa reactions grade*

Special remarks

1

 

 

 

 

2

 

 

 

 

3

 

 

 

 

4

 

 

 

 

5

 

 

 

 

6

 

 

 

 

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8

 

 

 

 

9

 

 

 

 

10

 

 

 

 

11

 

 

 

 

12

 

 

 

 

 

* 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?________________________________________

 

Follow-up protocol

 

Implant n:o

Fixture stable?

Abutment stable?

Skin/mucosa reactions grade*

Special remarks

1

 

 

 

 

2

 

 

 

 

3

 

 

 

 

4

 

 

 

 

5

 

 

 

 

6

 

 

 

 

7

 

 

 

 

8

 

 

 

 

9

 

 

 

 

10

 

 

 

 

11

 

 

 

 

12

 

 

 

 

 

* 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?________________________________________

 

Follow-up protocol

 

Implant n:o

Fixture stable?

Abutment stable?

Skin/mucosa reactions grade*

Special remarks

1

 

 

 

 

2

 

 

 

 

3

 

 

 

 

4

 

 

 

 

5

 

 

 

 

6

 

 

 

 

7

 

 

 

 

8

 

 

 

 

9

 

 

 

 

10

 

 

 

 

11

 

 

 

 

12

 

 

 

 

 

*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          

 

Patient information

 

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          

 

Informed consent

 

 

 

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

 

 

 

Note any adverse effect you suspect from any of given treatment