Safety and performance of OsStic synthetic injectable structural bio adhesive bone void filler in a first in human application to treat tibial fractures
| ISRCTN | ISRCTN94484905 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN94484905 |
| Sponsor | Biomimetic Innovations Ltd |
| Funder | Biomimetic Innovations Ltd |
- Submission date
- 26/11/2025
- Registration date
- 04/12/2025
- Last edited
- 04/12/2025
- Recruitment status
- Not yet recruiting
- Overall study status
- Ongoing
- Condition category
- Musculoskeletal Diseases
Plain English summary of protocol
Background and study aims
This study is testing a new material called OsStic, which is designed to fill gaps in broken bones. When someone breaks the top part of their shin bone (called a tibial plateau fracture), surgeons often need to lift the joint surface back into place. This can leave a space in the bone that needs to be filled to help the joint heal properly. Usually, surgeons use bone grafts or other substitutes. This study aims to find out if OsStic is safe to use in this type of surgery and to collect early information on how well it supports healing.
Who can participate?
Adults aged 18 or older who have a closed tibial plateau fracture that needs surgery with a plate and bone filler may be invited to take part. People cannot join if they have an open fracture, are in very poor health, are pregnant or breastfeeding, have certain infections or allergies, or cannot follow the study procedures.
What does the study involve?
Everyone in the study will have the usual operation to fix the fracture with a plate and screws. During surgery, the surgeon will inject OsStic into the gap in the bone. After surgery, participants will receive standard care and physiotherapy. They will attend follow-up visits for about 12 months after surgery (for example at 2 weeks, 6 weeks, 3 months, 6 months and 12 months). At these visits, doctors will check the leg, review any problems, and take X-rays or CT scans to see how the bone is healing. Participants will also complete questionnaires about pain, daily activities and quality of life. At some visits, they may be asked to walk wearing special insoles that measure pressure.
What are the possible benefits and risks of participating?
OsStic is designed to give better support to the joint surface and may help the bone heal well, but this cannot be guaranteed. The information from this study may help improve treatment for future patients. Risks include a small extra exposure to X-rays and CT scans and the inconvenience of attending follow-up visits.
Where is the study run from?
The study will take place in orthopedic trauma departments in the United Kingdom and will be coordinated by Biomimetic Innovations Ltd, based in Shannon, Ireland.
When is the study starting and how long is it expected to run for?
The study is planned to start recruiting patients in 2026. Recruitment will take about 12 months, and each participant will be followed for around 12 months after surgery. The study is expected to finish by 2028.
Who is funding the study?
The study is funded and sponsored by Biomimetic Innovations Ltd, the manufacturer of OsStic.
Who is the main contact?
peter.giannoudis@NHS.net
vijay@pbcbiomed.com
Contact information
Principal investigator
Trauma & Orthopaedic Surgery - School of Medicine University of Leeds
Leeds
LS1 3EX
United Kingdom
 ORCID ID |
0000-0002-5205-7696 |
|---|---|
| Phone | +44 1133 922750 |
| peter.giannoudis@NHS.net |
Scientific, Public
Unit 4D, Western Business Park
Shannon
V14 RW92
Ireland
| Phone | +353 (0)61704740 |
|---|---|
| vijay@pbcbiomed.com |
Study information
| Primary study design | Interventional | |
|---|---|---|
| Allocation | N/A: single arm study | |
| Masking | Blinded (masking used) | |
| Control | Uncontrolled | |
| Assignment | Single | |
| Purpose | Device feasibility, Treatment | |
| Scientific title | A pre-market, single group First in Human (FIH) study to evaluate the safety and performance of a Class III medical device-safety and performance of OsStic synthetic injectable structural bio adhesive bone void filler in a first in human application to treat tibial fractures | |
| Study objectives | To assess the safety of OsStic BVF on pain, functional outcomes in terms of weight-bearing, and overall patient satisfaction. | |
| Ethics approval(s) |
Not yet submitted | |
| Health condition(s) or problem(s) studied | Tibial plateau fractures | |
| Intervention | This is a prospective, single-arm interventional clinical investigation of the OsStic Synthetic Injectable Structural Bioadhesive Bone Void Filler (OsStic BVF) used during standard surgical fixation of closed tibial plateau fractures. Eligible subjects undergo routine open reduction and internal fixation (ORIF) with a proximal tibial plate according to local standard of care. After fracture reduction and plate fixation, OsStic BVF is prepared intra-operatively according to the Instructions for Use and injected into the metaphyseal bone void to provide structural support and void filling. The product is supplied as a 10 cc kit and the volume implanted is determined by the surgeon based on the size of the defect. Only surgeons trained in the use of OsStic BVF perform the implantation. Post-operatively, all subjects receive standard rehabilitation and are followed according to the study schedule with clinical assessment, radiographic/CT imaging and functional evaluation (including gait/load assessment using XSENSOR insoles) to characterize device performance and safety. | |
| Intervention type | Device | |
| Phase | Phase I | |
| Drug / device / biological / vaccine name(s) | OsStic Synthetic Injectable Structural Bio Adhesive Bone Void Filler (OsStic BVF) | |
| Primary outcome measure(s) |
| |
| Key secondary outcome measure(s) |
| |
| Completion date | 31/05/2028 |
Eligibility
| Participant type(s) | |
|---|---|
| Age group | Mixed |
| Lower age limit | 18 Years |
| Upper age limit | 80 Years |
| Sex | All |
| Target sample size at registration | 15 |
| Key inclusion criteria | 1. Patients with traumatic, closed, depression fracture of the tibial plateau (proximal tibia) (limited to AO fracture classification B2 & B3). 2. Candidate patient for bone grafting. 3. Being ambulatory before the injury. 4. Written informed consent. 5. Patients with communicative ability to understand the procedure and participate in the study and comply with the follow up program. 6. Willing and able (in the opinion of the study team) to provide informed consent and participate in all study activities and visits schedule. |
| Key exclusion criteria | 1. Open /compound tibial plateau fracture. 2. AO fracture classification Type C. 3. Pathological (Metastatic Tibial Fracture). 4. Multi-segmental nature of this fracture (more than one fracture site within tibia for intervention). 5. Polytrauma (defined as injury severity score of 17 or more). 6. Active systemic infection. 7. Clinically significant or unstable medical or surgical condition that may preclude safe and complete study participation. 8. Exposure to drugs that can affect the bone metabolic state within the past three months. 9. Any pre-existing calcium metabolism disorder (e.g., hypercalcemia). 10. Irreversible coagulopathy or bleeding disorder. 11. Receiving chemotherapy, radiation treatment or immunosuppression drugs. Patients on long term opioid medication buprenorphine, diamorphine, fentanyl, morphine and oxycodone. 12. History of physical or psychological condition that contraindicates the use of an investigational device or render the patient at high risk from treatment. 13. Pre-existing osteoarthritis. 14. Currently enrolled in any other study which may impact on the results of the present study. 15. If female: pregnant, breastfeeding, or not currently using and not willing to use an effective form of contraception for 12 months post-surgery. |
| Date of first enrolment | 16/02/2026 |
| Date of final enrolment | 15/02/2027 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Leeds
LS1 3EX
England
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not expected to be made available |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol file | 26/11/2025 | No | No |
Additional files
- 48566P~1.PDF
- Protocol file
