RecruitingPhase IInterventional

Safety and performance of OsStic synthetic injectable structural bio adhesive bone void filler in a first in human application to treat tibial fractures

This study is looking into a new substance called OsStic, designed to fill gaps in broken shin bones. When the top part of the shin bone (tibial plateau) breaks, surgeons often need to fill any empty spaces to help it heal properly. OsStic is hoped to provide better support. This early-stage study wants to check if OsStic is safe to use in people and how well it helps the bone heal after surgery. We're looking for adults with certain types of shin bone fractures who need surgery. Participants will have their fracture fixed as usual, receive OsStic, and then have follow-up checks for about a year, including X-rays and questionnaires. The goal is to improve future treatments for similar injuries.

At a glance

Status

Recruiting

Phase

Phase I

Sponsor

Biomimetic Innovations Ltd

Enrolment target

Start

16 Feb 2026

Estimated completion

15 Feb 2027

Tibial plateau fractures

What is this study about?

Imagine you've broken the top part of your shin bone, near your knee. This specific type of break is called a tibial plateau fracture. When this happens, sometimes the bone surface that forms part of your knee joint can get pushed down, leaving a gap or space in the bone underneath. To help your knee heal properly and prevent future problems, surgeons often need to lift this joint surface back into place and fill the empty space in the bone.

Traditionally, surgeons might use bone taken from another part of your body (a bone graft) or other materials to fill this gap. This study is testing a new, man-made material called OsStic. It's an injectable substance designed to act like a scaffold or filler, helping to support the bone while it mends. Because OsStic is new, this is an early study (what doctors call 'Phase I' or 'First in Human'), which means the main goal is to make sure it's safe for people to use. We also want to gather early information on whether it helps the bones heal properly.

The findings from this study are very important. If OsStic proves to be safe and effective, it could offer a new and potentially better way to treat these types of shin bone fractures in the future, helping more people recover well and get back on their feet. The information gathered will contribute to medical knowledge and potentially improve surgical options for patients with similar injuries.

Key takeaways

Tests a new injectable material (OsStic) for shin bone fractures.
Aims to check safety and how well it helps bones heal.
For adults with certain closed tibial plateau fractures needing surgery.
Involves standard surgery plus OsStic, followed by 12 months of check-ups.
Potential benefits for future patients; minor risks include extra scans and clinic visits.
You can stop participating at any time.

Who may be eligible?

This study is for adults, aged 18 or older, who have broken the top part of their shin bone (a 'tibial plateau fracture'). This type of break must be 'closed,' meaning the skin isn't broken, and it needs surgery where a plate and screws are used to fix it, as well as needing some material to fill a bone gap. You also need to have been able to walk before your injury and be able to understand and take part in all the study steps and follow-up appointments.

There are several reasons why someone might not be able to join the study. You can't take part if you have an 'open' fracture (where the bone breaks through the skin), or if your fracture is more complex than the types being studied. You also can't participate if you have very poor health, certain infections, or allergies to materials used in the study. We also can't include people who are pregnant or breastfeeding, have certain bone or blood disorders, or are taking specific medications that could affect the study results. People who have severe accidental injuries to multiple body parts, or those unable to follow the study schedule, also won't be able to join.

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 broken shin bone (tibial plateau fracture) that hasn't broken through the skin?
Do you need surgery for your fracture that will involve a plate and filling a bone gap?
Were you able to walk before your injury?
Are you able to attend follow-up appointments for approximately 12 months?

Answer every question to see your result.

What does participation involve?

If you join the study, you will have your shin bone fracture fixed with surgery, just like regular treatment. During this operation, the surgeon will inject the new material, OsStic, into the gap in your bone. After surgery, you'll receive the usual care and physiotherapy to help you recover. You'll need to attend several follow-up visits over about 12 months. These visits will typically be at 2 weeks, 6 weeks, 3 months, 6 months, and 12 months after your surgery.

At these visits, doctors will check your leg, ask about any problems, and take X-rays or CT scans to see how your bone is healing. You'll also be asked to complete questionnaires about your pain levels, how well you're managing daily activities, and your overall quality of life. At some visits, you might be asked to walk with special insoles in your shoes that can measure the pressure on your foot. The total time you'll be involved in the study, from surgery to your last follow-up, will be around 12 months.

Potential risks and benefits

There are some potential benefits to taking part. OsStic is designed to provide better support to your knee joint surface and could help your bone heal well, potentially offering a better recovery than standard treatments. However, we can't guarantee this. The information gathered from your participation will be very valuable and could help improve treatment options for many other patients with similar injuries in the future. As for risks, you will have a small amount of extra exposure to X-rays and CT scans during the follow-up visits, which is generally considered safe but is slightly more than typical care. The main inconvenience will be attending the scheduled follow-up appointments. Remember, you are free to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (1)

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

Trauma & Orthopedic Surgery - School of Medicine University of Leeds
City only
Leeds, England

Common questions

What is OsStic?

OsStic is a new, man-made injectable material designed to fill gaps in broken bones and help them heal. It's being tested in this study.

What kind of broken bone is this study about?

This study focuses on breaks at the very top of your shin bone, near your knee, specifically called tibial plateau fractures, where there's a gap in the bone that needs filling.

How long will I be involved in the study?

If you take part, you'll have follow-up appointments for about 12 months after your surgery.

Who is paying for this study?

The study is funded and sponsored by Biomimetic Innovations Ltd, the company that makes OsStic.

When is the study starting?

The study aims to start finding patients in 2026 and is expected to finish by 2028.

How to find out more

Vijay Vyas Vadhiraj

vijay@pbcbiomed.com +353 (0)61704740 Official trial record

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