CERAMENT G as Part of the Surgical Treatment of Osteomyelitis in a Single-Stage Procedure
This study is investigating a new way to treat a serious bone infection called osteomyelitis. Doctors are using a special bone filler, called CERAMENT G, during a single operation to remove the infection and fill the gap left in the bone. The main goal is to see how safe and effective this treatment is over time. They want to understand if it helps new bone grow properly and if there are any problems, like the infection returning or the bone becoming weak. This helps them understand if CERAMENT G is a good option for people with osteomyelitis who need surgery to clear the infection and rebuild the bone.
At a glance
What is this study about?
Imagine you have a serious bone infection called osteomyelitis. This infection can be quite tricky to get rid of and often needs surgery. Sometimes, after removing the infected bone, there's a gap or a 'dead space' left behind. This study is looking at how a special material, called CERAMENT G, can help fill these gaps and assist in the healing process.
CERAMENT G is a type of bone filler that can also release an antibiotic. The idea is that it helps the bone heal while also fighting off any remaining infection. This study focuses on using CERAMENT G during a single operation – meaning doctors try to clear the infection and fill the bone gap all at once, rather than needing multiple surgeries.
The main aim of this study is to gather information over a longer period about how well CERAMENT G works and if it's safe. Doctors want to see if new bone grows properly where CERAMENT G was used, how often any problems occur (like the bone not healing completely or the infection coming back), and how serious these issues might be. This information will help them understand if this treatment method is a good option for people with osteomyelitis.
Key takeaways
- This study looks at a bone filler called CERAMENT G for osteomyelitis surgery.
- It aims to see how safe and effective CERAMENT G is for bone healing and preventing infection.
- The treatment involves using CERAMENT G during a single operation.
- Doctors will check for complete bone healing and any infection recurrence over time.
- It's a study for adults aged 18 and over with specific types of bone infection.
Who may be eligible?
To be considered for this study, you would need to have osteomyelitis (a bone infection) that has been causing problems for at least six months. The infection would also need to be quite severe, fitting specific categories that doctors use to describe bone infections. After surgery to remove the infected bone, you would need a gap that CERAMENT G can fill.
Additionally, there would need to be clear signs of the infection, such as a persistent open wound (sinus), pus found during surgery, or laboratory tests showing strong evidence of infection. If your cultures are negative, other strong evidence of infection would be needed. This study is for adults aged 18 and over.
You wouldn't be able to join if your bones are still growing, if you're allergic to specific antibiotics (gentamicin) or calcium sulfate (components of CERAMENT G), or if you've already had other antibiotic bone fillers. Also, if the bone loss after surgery is very large (more than 1cm) or if your infection is in your spine, you wouldn't be suitable for this particular study.
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 18 years old or older?
- Do you have a severe bone infection (osteomyelitis) that has lasted at least 6 months?
- Will you have surgery to remove infected bone, leaving a gap?
- Are you able to provide your consent to be part of a study?
- Do you have any allergies to gentamicin or calcium sulfate?
- Is your bone infection NOT in your spine?
What does participation involve?
This study is a bit different from a typical trial where you might be given an experimental drug. Instead, it's about closely watching people who have already received CERAMENT G as part of their standard surgery for osteomyelitis. So, the main participation involves going through your usual treatment.
After your surgery, the research team will collect information about your recovery. This will include looking at your medical records, possibly taking X-rays to see how your bone is healing, and checking for any signs of the infection returning or other problems. While the brief details don't specify the exact number of visits or the total duration, it's described as a "longer-term" study, meaning you would be monitored over an extended period after your operation.
Potential risks and benefits
Locations (1)
- Bone Infection Unit, Nuffield Orthopaedic Centtre, Oxford University Hospitals, MHSVerified postcodeOxford, United Kingdom· Recruiting
Common questions
What is osteomyelitis?
Osteomyelitis is a serious infection of the bone that can be difficult to treat and often requires surgery.
What is CERAMENT G?
CERAMENT G is a special bone filler that is used to fill gaps in bones after surgery and also contains an antibiotic to help fight infection.
Why is this study being done?
This study wants to learn more about how well CERAMENT G works and how safe it is over a longer period when used in a single operation for osteomyelitis.
What kind of information will be collected?
Doctors will gather information on how your bone heals, if the infection returns, and any other problems you might experience after your surgery.
Can anyone with osteomyelitis join this study?
No, there are specific requirements for joining, such as the type and severity of your infection, your age, and other medical conditions.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
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