Clinical Study of Bone Graft Substitutes in Orthopaedic and Spinal Applications.
This study is gathering information on artificial bone graft substitutes used in everyday medical practise. These substitutes are materials designed to help new bone grow and heal. The study focuses on people who need bone repairs in their long bones (like thigh or arm bones), or in their arms, legs, hands, or feet after injuries or surgery. It also includes people needing spinal fusion, which is an operation to join two or more bones in the spine together. Researchers want to understand how safe and effective these bone substitutes are in a real-world setting. This isn't a study where people are given a specific treatment; instead, doctors are using these bone substitutes as part of their standard care, and researchers are simply observing the results.
At a glance
What is this study about?
This study is called a 'post-market clinical follow-up' study. This means that the bone graft substitutes being looked at are already approved for use and doctors are using them in their regular practice. Researchers are carefully watching how these materials work in people needing bone repairs, rather than testing something completely new.
The main goal is to collect real-world information about how safe and helpful these artificial bone graft substitutes are. These materials are used when a person needs extra support or help healing after bone defects, which can happen after an injury or surgery. They are also used in spinal fusion, a procedure where bones in the spine are joined together to reduce pain and improve stability.
By observing many patients in different hospitals, researchers hope to get a clear picture of how well these bone substitutes perform in everyday situations. This information can help doctors and patients make informed decisions about the best ways to repair and heal bones in the future.
Key takeaways
- Observing real-world use of approved bone graft substitutes.
- Aims to understand safety and effectiveness in bone repair.
- For patients needing bone grafts in limbs or spinal fusion.
- Not testing new treatments; it's about collecting data.
- Participation involves routine medical follow-ups.
- Ages 18-80 can participate, excluding pregnant women.
Who may be eligible?
This study is for adults aged 18 to 80. You might be able to take part if you need bone grafting for conditions affecting your long bones (like your thigh or arm bones), or other bones in your arms, legs, hands, or feet, especially after an injury or surgery.
It's also for people who need spinal fusion (where bones in the spine are joined together) due to issues like degenerative disc disease or trauma, and where other treatments haven't worked. You must be willing and able to understand the study and give your permission to take part, and be able to attend all necessary follow-up appointments.
You cannot join if you are already in another study that might affect this one, or if you are pregnant or planning to become pregnant during the study. You also shouldn't join if you are unable or unwilling to come for follow-up visits throughout the 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 between 18 and 80 years old?
- Are you needing bone repair in your limbs or a spinal fusion?
- Are you able to understand the study and agree to take part?
- Are you able to attend all your routine hospital appointments?
- Are you not pregnant or planning to become pregnant during the study?
What does participation involve?
If you take part in this study, it means your doctors will be using an artificial bone graft substitute as part of your standard medical care, and then researchers will observe how you recover. This is not a study where you are given a new or experimental treatment. You will have your usual medical appointments and check-ups related to your bone repair or spinal fusion. The healthcare team will collect information about your recovery and how well the bone substitute is working. The total number of visits and the duration of your participation will depend on your specific medical condition and how long your doctor typically follows up after your procedure.
Potential risks and benefits
Locations (7)
- Doncaster & Bassetlaw Teaching Hospitals NHS Foundation TrustVerified postcodeDoncaster, United Kingdom
- Sandwell and West Birmingham NHS Trust of City HospitalVerified postcodeBirmingham, United Kingdom
- The Royal Orthopaedic Hospital NHS Foundation TrustVerified postcodeBirmingham, United Kingdom
- Northumbria Healthcare NHS Foundation TrustVerified postcodeNorth Shields, United Kingdom
- Salford Royal NHS Foundation TrustVerified postcodeSalford, United Kingdom
- University Hospitals of North Midlands NHS TrustVerified postcodeStoke-on-Trent, United Kingdom
- Taunton and Somerset NHS Foundation TrustVerified postcodeTaunton, United Kingdom
Common questions
What is a 'bone graft substitute'?
It's an artificial material designed to help your natural bone grow and heal, often used when there isn't enough of your own bone, or to encourage repair.
Is this a new treatment?
No, the bone graft substitutes being used are already approved for medical use. This study is just observing how they work in real life.
What does 'spinal fusion' mean?
Spinal fusion is an operation to join together two or more bones in your spine, often to reduce pain or make your spine more stable.
Will I have extra appointments?
You will have your usual appointments for your bone repair or spinal fusion. Researchers will simply be collecting information during these routine visits.
Can I leave the study if I change my mind?
Yes, you can leave the study at any time, and it will not affect the medical care you receive.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Discussion
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