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

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

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN94484905

Enrollment

Registered

2025-12-04

Start date

2026-02-16

Completion date

Unknown

Last updated

2026-01-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Tibial plateau fractures Musculoskeletal Diseases

Interventions

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 o

Eligibility

Sex/Gender

All

Age

18 Years to 80 Years

Inclusion criteria

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.

Exclusion criteria

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.

Countries

England, United Kingdom

Contacts

Public ContactVijay Vyas Vadhiraj

vijay@pbcbiomed.com+353 (0)61704740

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026