Percudyn Trial

The Percudyn trial was started at Imperial College Healthcare NHS Trust in Autumn 2009. It aims to assess the effectiveness of Percudyn. Although the device has passed it’s safety test and early data show some promising results, we would like to collect more information about the benefits patients have from this.

Patients are only invited to join the study when referred to the Spine Clinic at Charing Cross Hospital, London. The information below is intended for patients wishing to join the study.

 

 

Patient Information Sheet

(Version3 9July2009)

STUDY TITLE: A study to evaluate the effectiveness of the Percudyn System to treat back pain associated with degenerative disc disease.

CHIEF INVESTIGATOR NAME:  Mr Christian Ulbricht, MD, MRCS, FRCS (Neurosurg)

 

PATIENT NAME: ____________________________________________________

Introduction

You are being invited to take part in a research study.  Before you decide to take part it is important for you to understand why the research is being done and what it will involve.  Please take time to read the following information carefully and discuss it with friends, relatives and your GP if you wish.  Ask us if there is anything that is not clear or if you would like more information.  Please take time to decide whether or not you wish to take part.  If you do decide to take part you will be given a copy of this patient information letter and a signed consent form to keep.
This study is being conducted so we can evaluate a new medical device that is intended to treat patients like you, who are suffering with low back pain caused by disc degenerative disease (DDD). DDD can affect any part of the spine, although the common sites are the lumbar (lower back) and cervical (neck) spine.

Why have I been chosen?

You are being asked to participate in this study because you are suffering with mild to moderate disc degenerative disease. Your surgeon has determined that conservative (non-surgical) therapy has not alleviated your pain sufficiently and has therefore suggested that you be treated surgically. This study will include up to 50 patients. All patients, like you, need to have surgery for their symptoms.

What is the purpose of the study

After unsuccessful management of low back pain with conservative treatment like physiotherapy and painkillers, one form of management of this condition is to use spine implants, which fixate and stabilise the spine. The most common surgical procedure is a spinal fusion. This immobilises the painful segment of the spine. The disadvantage is that it is a major operation and may cause excessive wear and tear on discs above or below the fusion years after surgery. The Percudyn System, however, works slightly differently in that it acts to give stability to the spine without fusion. The Percudyn system offers the opportunity to stabilise the spine for those patients that do not want to undergo fusion surgery.

In this study the disc that is degenerating would be stabilised with the Percudyn System.
The Percudyn system would restrict movement in the direction or plane that produces pain, but would otherwise allow a full range of motion. The Percudyn System is inserted through two small holes made directly through the skin (15mm, bilateral, minimally invasive access ports), whereas other existing similar Dynamic Stabilisation Devices require a 40-60mm midline incision and an even larger incision would be used for spinal fusion.

The study will run for a minimum of 12 months after treatment. We will monitor you during this period to assess how you are feeling and how effective the device is in improving your symptoms of degenerative disc disease.  Ideally the study will continue for a further 5 years after surgery to increase the long-term knowledge about how well the Percudyn system works. This, however, will be dependent of findings secured at a later date.

Why do we need to evaluate the Percudyn system?

The product is fully licensed in the UK and is safe to use. There have been international studies reporting favourable results but the effectiveness and long term outcome is unknown. We would like to obtain as much information as possible from patients who had this procedure to assess how much they have benefited.

What is the product being tested?

The product being tested is known as the Percutaneous Dynamic Stabilisation System (Percudyn System). Your doctor will show you what it looks like.

Do I have to take part?

It is up to you to decide whether or not to take part.  If you do decide to take part you will be given this information sheet to keep and be asked to sign a consent form.  If you decide to take part you are still free to withdraw at any time and without giving a reason.  A decision to withdraw at any time, or a decision not to take part, will not affect the standard of care you receive.

What will happen to me if I take part?

If you decide to take part in the study, and you meet the entry requirements you will participate for at least 12 months.

Before you receive any treatment, your doctor will record your medical history, carry out a physical examination and perform a number of spine x-rays (like a photograph) and MRI (Magnetic Resonance Imaging) to see exactly which disc is causing the problems you are experiencing. All of these procedures are part of the normal routine management of your treatment, even if you were not in the study. You will also be asked to answer a series of simple questions about your symptoms and health. These examinations and questions will be asked so that we can fully assess your progress and recovery.

On the day of treatment, you will be taken to the operating theatre where you will be put to sleep by general anaesthetic. Your hospital doctor will explain to you in more detail about the surgical procedure. The surgical procedures will cause some discomfort and your hospital doctor will discuss these with you. After treatment, you will be sent home from hospital usually within 24 hours.
 
After treatment, you will be asked to attend the clinic for follow-up visits at intervals of 6 weeks, six and twelve months. At these visits further spine x-rays might be taken and physical examinations will be performed. This is a routine after spinal operations like this. You will also be asked to answer a series of simple questions, which will be in the form of questionnaires about your symptoms and health. These examinations and questions will be asked so that we can fully assess your progress and recovery.

What special restrictions do I have to follow if I take part?

The restrictions you will be asked to follow are the same as if you were having standard spine surgery and your hospital doctor will explain these to you.

What are the alternatives for treatment?

Treatment with the Percudyn system is not the only possible treatments for lower back pain associated with degenerative disc disease. Other treatments include physical therapy, facet injects, other dynamic stabilisation devices, total disc replacement or other types of fusion surgery. Your doctor will discuss all these options with you before you decide to take part in the study.
Unfortunately, there is no guarantee that your back pain will improve with any conservative or surgical treatment. Many studies have shown benefits from all surgical options but all have also risks and may not help in some patients. This is why we think a device like the Percudyn has an advantage because it does not effect important parts of the spine like a fusion or disc replacement. It is minimal invasive and therefore has very small adverse effects on the muscles and other structures of the spine, which are often effected by open surgery. Percudyn is reasonably new on the market but has full safety approval. It has been shown in recent trials to be beneficial to patients with very low complication rates. Your surgeon can provide you with the details of the publications.

What happens if the treatment has not improved my back pain?

In this case, there are two options. If there are no additional problems and the pain has not worsened, the implant can be left in the spine.
However, in the event that the implant is causing additional discomfort or pain, it can be removed. The damage that has been done to the spine by the implantation of Percudyn is minimal unlike in other surgical techniques. You can also still have a spinal fusion at a later stage, should you want this. Removing the implant will be done through the same scar and is very unlikely to leave you with any additional problems.

What are the side effects of taking part?

There are no known side effects to being treated with this system but there may be unknown side effects. If after treatment you suffer any symptoms you should report them at your next visit, or if you are in any way concerned contact Mr ….…………………………. on …………………………………….

What are the possible disadvantages and risks of taking part?

As with any surgical procedure, there are risks involved with the surgery and the anaesthesia. The risks associated with spinal surgery may include bleeding, damage to the nerves and spinal cord, reduced mobility or infection.

Risks specific to the Percudyn System include, but are not limited to: allergic reaction to the device; mis-alignment of the screws leading to perforation of the cortical walls of the pedicle penetrating the spinal canal or foraminal openings and causing damage to the neural elements and vascular structures; implant breakage due to a pseudarthrosis (a false joint formed when the two parts of a fractured bone have failed to unite together); decrease in bone density; pain, discomfort or abnormal sensations due to the presence of the device; nerve damage due to surgical trauma; bone necrosis; and vascular changes.

These risks are usually small but can be serious. Nevertheless, the risks of fusion surgery are higher. A complication may require revision surgery and, very rarely, a complication may prove fatal.

Any of these events may or may not happen, but if they do you will receive the appropriate care and medical attention from the doctor treating you. It is important that you ask your doctor if you have any questions or do not understand any of these risks.

What are the possible benefits of taking part?

We hope that treatment with the Percudyn System will prove to be beneficial and will help you. It is hoped that the Percudyn System may enable you to have a greater mobility compared to a fusion procedure. However, it is possible that you may get no benefit from this study although the knowledge gained may help our understanding and improve treatment options for people like yourself. 

What if new information becomes available?

Sometimes during the course of a study, new information becomes available about the treatment that is being studied.  If this happens, your doctor will tell you about it and discuss with you whether you want to continue in the study.  If you decide to withdraw, your doctor will make arrangements for your care to continue.  If you decide to continue in the study you will be asked to sign an updated consent form.

Also, on receiving new information your doctor might consider it to be in your best interests to withdraw you from the study.  Your doctor will explain the reasons and arrange for your care to continue.

What happens when the study comes to an end?

At the end of the study your hospital doctor will continue to offer you appropriate medical care and attention as needed.  You will continue to be under the care of your hospital doctor and can contact him should you become concerned or develop any medical condition which you think might be related to the surgery performed or the study.

What if something goes wrong?

Should any problems or questions arise with regard to this study, with regards to your rights as a participant in clinical research, or with regard to any research related injury, you should contact the Investigator at the number listed below:

Investigator Name: Mr Christian Ulbricht    
Telephone Number: 020-88461848

There is indemnity insurance by Imperial College NHS Trust covering the operation and clinical management which is no different to any other operation performed in this Trust. Separate worldwide product indemnity insurance by the company producing Percudyn (Interventional Spine) applies for the implant itself.

The investigator reserves the right to terminate the study at any point when he believes that important adverse events might result from its continuation.

Will my taking part in this study be kept confidential?

If you consent to take part in the study, any of your medical records may be inspected by members of the research team of the study for purposes of analysing the results. Your name, however, will not be disclosed outside the hospital.  You will be identifiable during the study by your initials, sex, date of birth and a unique study number allocated to you.

All information which is collected about you during the course of the study will be kept strictly confidential.  Any information about you which leaves the hospital will have your name and address removed so that you cannot be recognised from it. Only data without your details will be passed on to a statistician for analysis.
With your permission, we also wish to inform your General Practitioner (GP) that you are taking part. In giving your consent you are stating that you have no objection to any of the above.

What will happen to the results of the study?

At the end of the study the results will be analysed and may be published in one of the journals on the spine although you will not be identified in any way.

How can I know about the outcome of the study?

We aim to publish the outcome of this study in a scientific journal. It will also be made available to the public and participating patients in non-medical terms.

Who is organising and funding the research?

The study is being organised by Imperial College Healthcare NHS Trust and partially sponsored by a company called Interventional Spine, Inc who is developing Percudyn as a treatment for mild to moderate disc degenerative. Your doctor will not be paid for including you in this study, instead a fee for each patient enrolled will be paid into an account for managing the data collection and paying for some of the implant costs.

Who has reviewed the study?

The local Ethics Committee and NHS R&D office at your hospital have reviewed the study.

What if I have more questions or would like more information?

You may ask any questions you like at any time about your rights as a participant in a research study or about the research study itself. 

Mr ..………………………………will be available to discuss these issues with you if you phone him on …. …………………………….  You may also contact your GP if you would like some independent advice before entering the study.

THANK YOU VERY MUCH FOR CONSIDERING TAKING PART IN OUR RESEARCH.