IDET Information

IDET STUDY INFORMATION SHEET

Study Title: Randomized Double-Blind Controlled Efficacy Study:
SpineCATH™ vs Placebo

Investigators: Professor Robert D. Fraser, Dr David Hall, Dr Christopher Cain

1 INTRODUCTION

You are invited to participate in a research study to evaluate a new device used to treat lower back pain. We hope to prove that the relief of symptoms after treatment with the SpineCATH™ is not due to a placebo effect.

This sheet describes the study and your role as a participant. If you agree to participate after reading and understanding this document and talking to your doctor about the study, you will be asked to sign a consent form and be enrolled into the study. You may not participate in any other research study at the same time as this one.

2 STUDY DESCRIPTION

The purpose of this study is to compare treatment with the SpineCATH™ Intra-discal Catheter to a placebo surgery. The SpineCATH™ has been used in over 4500 cases in the United States but there is concern that the improvements in some patients are due to a placebo effect. (A “placebo effect” is when there is an improvement in the patient’s condition from an inactive or dummy treatment.) The placebo treatment is experimental.

In this study, subjects will receive either the active SpineCATH™ treatment or the inactive SpineCATH™ placebo treatment. Treatments are randomly assigned and neither the patient nor the doctor will know which treatment is given (called “blinding”). The randomisation and blinding process is described later.

The study will be conducted by Professor Fraser, Dr Hall or Dr Cain of the Spinal Unit at Royal Adelaide Hospital. Approximately 75 patients will be included in the study. Patients will remain in the study for six months following treatment.

3 BACKGROUND

The SpineCATH™ Intradiscal Catheter is used to treat painful discs in the treatment of lower back pain. The procedure is considered a minimally invasive surgery. The medical condition you are being treated for is often referred to as a disc disruption or degenerative disc disease.

The SpineCATH™ is a long, flexible wire that has a 5cm heater section at the end. It is guided around the inside of the disc as it passes through a special introducer needle. The SpineCATH™ is connected by a cable to the energy generator. Energy is delivered to the catheter which gradually becomes very hot (up to 90º C) and shrinks the torn and damaged tissue in the disc. The temperatures also may destroy any pain-sensing nerves in the disc.

4 SPINECATH™ STUDY PROCEDURES

As a study project, you will be responsible for attending at least 4 office visits (before treatment and at 6 weeks, 3 months and 6 months after treatment). You will have a physical exam to evaluate your medical condition and nervous system and be asked to complete a questionnaire. It takes about 15 minutes to answer the questionnaire.

For your safety, there are certain tests and procedures that need to be done first to make sure you are a suitable candidate for this new treatment. These tests include a discogram and may include Magnetic Resonance Imaging (MRI - an electronic photo of your spine), and x-rays.

In this project, you will be exposed to radiation at a level considered safe for you as long as you have not also been exposed to radiation in other research projects in the last twelve months. Please discuss this with the investigator if you have had any exposure to radiation as a research project volunteer in the last twelve months.

The treatment will take place in an operating room with X-ray equipment. You will receive local anaesthetic and sedative medication to help keep you relaxed and still during the procedure. You will be placed on an operating table and prepared for the surgery. A needle will be placed in your back to gain access to the painful disc. A SpineCATH™ device will be inserted through the needle and placed in the disc. The treatment takes about 17 minutes after the SpineCATH™ is placed. Total time in the operating room averages 45 minutes to one hour.

You will remain awake and monitored for discomfort or pain during the procedure. Changes in your blood pressure and heart rate will also be monitored. After the procedure, a bandage will be placed over the entry point on your back. You can be expected to be able to go home the same day. Someone else will need to drive you home as you may still be experiencing effects from the sedation.

5 PLACEBO AND RANDOMISATION DESCRIPTION

In this study, a placebo treatment means that the treatment device will not be delivering heat to the disc tissue. In all ways but that one, the placebo treatment is just like the active treatment, including length of time on the operating table, sedation and antibiotics administration. The generator will display all the normal read-outs, including appearing to deliver energy. Everything in the patient’s care (diagnosis, surgery conduct and follow up care) will be exactly the same for active and placebo treatments.

Neither you nor your doctor will know which treatment you receive. It is important that your doctor not know what treatment you receive so that his care of you does not differ between one treatment and the other.

You will have a two in three chance of receiving the active SpineCATH™ treatment. Based on special software, the generator will decide whether your treatment is active or placebo and its decision will be stored for future unblinding. Six months after your procedure, you will learn whether you had the active or the placebo treatment.

It is important to remember that you may or may not feel improvement with either treatment. The purpose of this study is to decide which group does better.

Your doctor will inform you of any new significant findings that develop during the course of research which may relate to your willingness to continue in the study.

6 RISKS AND DISCOMFORTS

The potential risks associated with this treatment are similar to the risks associated with the standard diagnostic test of discography which include; temporary general low back pain, infection, swelling, and temporary loss of some sensations. You may also feel a high level of discomfort during the treatment, caused by the placement of the needle and the presence of the catheter in the disc. You may suffer an unanticipated reaction to sedative or antibiotic medications that are administered during the treatment.

It is possible you may not have any improvement as a result of the procedure. Some patients feel increased discomfort at the site of the needle placement from one to four weeks after treatment.

There is a small risk of injury to the spinal nerves in the spinal canal, believed to be less than 1 in 10,000. This may cause a change in sensation in your leg and/or leg muscle control. Monitoring during the procedure should avoid this problem. There is a risk that the equipment could break inside the back, estimated to be less than 1 in 1,000. This may require immediate surgical removal of any pieces.

Pregnant women are not eligible for enrolment in this study due to exposure of a fetus to unknown risk. You may become pregnant after the study without risk to the fetus. The procedure will not present any risk to nursing infants.

7 BENEFITS

The potential benefits to you may include the improvement of chronic lower back pain without the risks of major surgery or general anaesthesia. Knowledge gained from this study may help to further understanding and improve treatment options for conditions like yours. We cannot promise that you will receive any benefits from this study.

8 ALTERNATIVE THERAPIES FOR YOUR CONDITION

Other treatments available for your condition may include a chemonucleolysis, artificial disc prosthesis, or spinal fusion (major surgery). Your doctor is available to explain the risks and benefits of these alternative treatments. You have already been treated with the conservative care therapy, consisting of exercise and physical therapy. The natural progression of this condition, without treatment, shows that this type of pain may be long lasting.

9 CONFIDENTIALITY OF PARTICIPANTS

Your identity as a participant in this study will be confidential. Your identity will be coded on all data recorded from your participation. Any appropriate regulatory authority as well as the sponsor of this study (Oratec Interventions Inc.) may have access to your medical records to verify the data from your treatment and follow up. The results of this study may be published or presented at profession conferences, but your identity will not be revealed.

10 FINANCIAL RESPONSIBILITY AND INJURY

The cost for the standard office visits will be covered by you or your insurance company as standard of care. Financial support for the procedure will be provided by the sponsor, Oratec Interventions Inc, to the hospital. You will not receive any financial support directly from the sponsor or the investigator.

If you have any injury or medical complications directly related to your participation in this study, medical treatment will be available for you through your treating surgeon. Financial compensation for treating such an injury or for lost wages, disability or discomfort due to this type of injury is not available. This study does not provide financial assistance for additional medical or other costs.

You do not waive any liability rights for personal injury by signing this form.

11 WITHDRAWAL OR DISCONTINUATION OF STUDY

Your decision whether or not to participate in this study will not jeopardize your medical care. You may choose to withdraw from this study at any time. This will not affect any current or future medical care to which you are entitled under your normal health care arrangements.

The study doctor may decide to withdraw you from the study without any consent at any time at his/her discretion.

You are encouraged to complete the entire study, including the follow up visits, so your doctor can monitor the effectiveness of your treatment.

12 VOLUNTARY CONSENT AND QUESTIONS

You should understand that your participation in this study is voluntary and that you may withdraw at any time. You can get more information on this study by calling the investigator, Professor Robert Fraser at 8222 4466. You may also contact the Research Ethics Committee if you have any questions regarding your rights as a research subject. Dr Michael James (8222 4139) is Chairman of the Research Ethics Committee and is available to discuss general aspects of the project.