Safety and Performance of OsStic Bone Void Filler
Research type
Research Study
Full title
Safety and Performance of OsStic Synthetic Injectable Structural Bio-Adhesive Bone Void Filler in a First-in-Human Application to Treat Tibial Fractures.
IRAS ID
360651
Contact name
Peter Giannoudis
Contact email
Sponsor organisation
Biomimetic Innovations Ltd
ISRCTN Number
ISRCTN94484905
Duration of Study in the UK
2 years, 3 months, 30 days
Research summary
This study is the first time the OsStic Synthetic Injectable Structural Bio‑Adhesive Bone Void Filler (“OsStic BVF”) will be used in patients. The study aims to find out if this new device can be used safely alongside standard surgery for tibial plateau fractures — a break at the top of the shin bone near the knee. These injuries are difficult to repair because they can create gaps in the bone (bone voids) and small, fragile pieces that are hard to hold in place with plates and screws alone.
OsStic BVF is a man‑made (synthetic) material with no animal or human tissue. It comes as a sterile powder and liquid, which are mixed in the operating theatre and injected into the fracture. The material hardens quickly without producing heat, helping to hold bone fragments together and fill the gaps. Over time, it dissolves naturally and is replaced by the patient’s own bone as healing occurs.
The main question this research will answer is: Can OsStic BVF be used safely in surgery to repair these fractures? The study will also look at early performance, including whether the material stays in place and supports the fracture during recovery.
Adult patients with suitable tibial plateau fractures will be invited to take part. All participants will receive standard fracture surgery plus OsStic BVF. Recovery will be followed for up to 12 months, using X‑rays, physical function tests, and patient questionnaires.
If the results are positive, this research could lead to larger studies and, in the future, a new treatment option to improve bone stability, reduce complications, and support better recovery after complex joint‑related fractures.
REC name
West of Scotland REC 4
REC reference
26/WS/0002
Date of REC Opinion
27 Feb 2026
REC opinion
Further Information Favourable Opinion