RecruitingOBSERVATIONAL

OSsIRIS Study - A Post-market Clinical Follow-up Investigation.

The OSsIRIS study is observing how a special material, called b.Bone, helps people whose bones need fixing. This could be after an injury or a planned surgery. Doctors use b.Bone to help bones heal in places like your hips, arms, and legs. This study simply watches patients who are already having this treatment, meaning there are no extra special treatments involved. The main goal is to check that b.Bone works well and safely in real-world use. Patients will have check-ups at 3, 6, and 12 months, and sometimes up to 24 months, as part of their usual care. It involves around 135-193 patients in the UK and Europe. If you're having this bone grafting, your doctor might ask if you'd like to take part.

At a glance

Status

Recruiting

Sponsor

GreenBone Ortho S.p.A.

Enrolment target

135

Start

31 Jan 2024

Estimated completion

01 Oct 2027

Surgically Created Bone Defects or Bone Defects/Voids Resulting From Traumatic Injury

What is this study about?

The OSsIRIS study is looking at a bone grafting material called b.Bone. When you have an injury or surgery that creates a gap or weak spot in a bone, particularly in your pelvis, arms, or legs, doctors sometimes use a 'bone graft' to help it heal. This graft acts like a scaffold, encouraging your own bone to grow and repair the area. b.Bone is one such material, and this study aims to see how well it works and if it's safe for patients in real-life situations.

This isn't a study where you get a new or experimental treatment. Instead, it's observing patients who are already having a bone grafting procedure with b.Bone as part of their regular care. Essentially, doctors are just keeping a close eye on your progress and how your body responds to the b.Bone, using your routine check-ups. They want to confirm that it's performing as expected and helping bones heal properly.

The information gathered from this study is really important. It helps doctors and healthcare providers understand more about how b.Bone works for different patients, making sure it continues to be a good and safe option for bone repair in the future. By joining, you're helping to improve our understanding of this treatment for many others.

Key takeaways

The study looks at b.Bone, a material used for bone repair.
It checks how well b.Bone works and if it's safe after surgery or injury.
You won't get any new treatments; it just observes your usual care.
Participation involves sharing information from your regular follow-up appointments.
It helps doctors understand more about bone healing for future patients.

Who may be eligible?

To be part of this study, you need to be at least 18 years old. You must be having a bone grafting procedure using b.Bone for a bone problem in your arms, legs, or pelvis, as it's part of your usual medical care. It's also important that you are willing and able to attend your regular follow-up appointments.

There are some reasons why you might not be able to join. For example, if your doctor believes b.Bone isn't suitable for you based on your medical history, or if you're already in another study that might clash with this one. Pregnant or breastfeeding women also cannot take part. Your doctor will discuss all of this with you to make sure the study is a good fit.

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?
Are you having bone graft surgery with b.Bone for a bone defect in your pelvis, arm, or leg?
Are you able to attend your routine follow-up appointments?
Are you not pregnant or breastfeeding?
Are you willing to participate and allow your anonymous health data to be used for research?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you won't need to do anything extra beyond your usual medical care. The study will monitor your progress during your existing doctor's visits. You'll have check-ups at about 3, 6, and 12 months after your surgery. For some patients, especially if you need metalwork removed later, these check-ups might continue for up to 24 months.

During these visits, your medical team will collect information about your health and how your bone is healing, just as they would normally. This includes any scans or tests you would typically have. The study simply uses the information from these routine appointments to see how b.Bone performs over time. There are no additional appointments, medications, or procedures involved that are just for the study.

Potential risks and benefits

Generally, there are no extra risks involved in taking part in this study, as it only observes your experience with b.Bone as part of your standard treatment. You'll simply be followed more closely during your routine care. The potential benefit is that by sharing your health information (already collected during your usual appointments), you'll be contributing to valuable research that helps improve understanding of bone grafting for future patients. You are always free to change your mind and stop participating at any time without it affecting your medical care.

Locations (4)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

BG Klinikum Unfallkrankenhaus Berlin
Verified postcode
Berlin, Germany· Recruiting
Trauma Surgery Department - University Hospital Regensburg
Verified postcode
Regensburg, Germany· Recruiting
Hull University Teaching Hospitals NHS Trust
Verified postcode
Hull, United Kingdom· Recruiting
Department of Trauma and Orthopaedic Surgery, Leeds General Infirmary
Verified postcode
Leeds, United Kingdom· Recruiting

Common questions

What is b.Bone?

b.Bone is a material used by surgeons to help bones heal, especially when there's a gap or defect in the bone after injury or surgery.

Will I get special treatment if I join?

No, this study just observes your usual treatment with b.Bone. You won't receive any extra treatments or medications just for being in the study.

How long will the study follow me?

You'll be followed for about 3, 6, and 12 months after your surgery, sometimes up to 24 months, during your regular check-ups.

Do I have to attend extra appointments?

No, all the information for the study will be collected during your existing, routine doctor's visits.

Can I leave the study at any time?

Yes, you are free to stop participating in the study whenever you wish, and it will not affect your medical care.

How to find out more

Sonia Granados, MSc

sonia.granados@greenbone.it +393450954463 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.