Study Comparing the PathKeeper System for Pedicle Screw Positioning in Spine Surgery With Traditional Care
This research study is comparing a new surgical tool, the PathKeeper System (PKS), with the standard way surgeons operate on spines. The main goal is to see if PKS helps place screws more accurately during operations for conditions such as scoliosis, which is a curve in the spine. Patients will be randomly put into two groups: one where surgeons use the PathKeeper System and another where they use the traditional method with X-ray guidance. The study will also look at things like how long the surgery takes, how much radiation patients are exposed to, and how long they stay in hospital. This helps doctors understand if the new system is a safer and more efficient way to perform these complex spine surgeries.
At a glance
What is this study about?
This study is all about making spine surgery better and safer for patients. When surgeons operate on the spine, they often need to place screws to help straighten and support it, especially for conditions like scoliosis, which is a curve in the spine. Placing these screws very precisely is extremely important.
The study is testing a new system called the PathKeeper System (PKS). Think of it like a very advanced Sat-Nav system for surgeons' tools during an operation. The main aim is to see if using PKS helps surgeons put these screws in exactly the right place compared to the more traditional method, which uses X-rays to guide them. By improving accuracy, the hope is to reduce complications and make recoveries smoother for patients.
Researchers will also be looking at other important details, such as how long the surgery takes, how much radiation patients are exposed to (from X-rays), how long patients need to stay in the hospital, and how much blood is lost during the operation. All this information helps doctors decide if the PathKeeper System is a valuable improvement for spine surgery.
Key takeaways
- The study compares a new system (PathKeeper) for guiding spine surgery with the usual method.
- It aims to improve how accurately screws are placed during operations for conditions like scoliosis.
- You must be at least 16 and having open spine surgery to be eligible.
- You'll be randomly assigned to either the new system or standard care group.
- The study will look at screw accuracy, surgery time, and patient safety outcomes.
Who may be eligible?
To be able to take part in this study, you need to be at least 16 years old. Both men and women can join. Importantly, you must be getting ready to have open spine surgery where screws will be put into your spine.
Before you can officially join, you'll need to read and sign a special form called an 'informed consent form'. This form explains everything about the study, including what's involved, and makes sure you understand and agree to take part.
Could this study suit you?
Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.
- Are you 16 years old or older?
- Are you a man or a woman?
- Are you currently scheduled for open spine surgery where screws will be placed?
- Are you comfortable signing a consent form after understanding the study?
What does participation involve?
If you decide to join this study, your involvement will primarily revolve around your scheduled spine surgery. You will be randomly assigned to one of two groups: one group will have their surgery using the new PathKeeper System, and the other will have their surgery using the standard method with X-ray guidance.
The main assessment will be a low-dose CT scan after your surgery. This scan helps the doctors check how precisely the screws were placed. Besides the special scan, the study will simply collect information about your surgery, such as how long it took, the amount of X-ray exposure, how long you stay in hospital, and any complications. There are no additional visits, medications, or long-term follow-up beyond what's part of your usual surgical care.
Potential risks and benefits
Locations (1)
- Leeds HospitalVerified postcodeLeeds, United Kingdom
Common questions
What is scoliosis?
Scoliosis means your spine has a curve instead of being straight. It can affect different parts of your back and can sometimes need surgery to correct it.
What is the PathKeeper System?
It's a new technology that acts like a special navigation system for surgeons, helping them place screws more accurately during spine surgery. It's being compared to traditional methods.
Will I know which treatment I'm getting?
Yes, this study is 'open label,' meaning both you and your doctors will know whether the PathKeeper System or the standard method is being used during your surgery.
Will I have more scans if I join the study?
You will have a low-dose CT scan after your surgery specifically to check the screw placements. This helps the researchers evaluate the new system.
What does 'randomized' mean?
It means you'll be put into one of the two study groups (PathKeeper or standard care) by chance, like flipping a coin. This helps make the study fair.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
Discussion
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