Tibial Fracture - Platelet-rich Plasma and Bone Marrow Concentrate

A Prospective, Randomised, Single-centre Feasibility Study of Combined Autologous Platelet-rich Plasma and Concentrated Autologous Bone Marrow in Adult Patients With a Fresh Unilateral Tibial Diaphyseal Fracture Treated With Either Fine Wire Ring Fixator Device (Ilizarov) or Reamed Intramedullary Nailing

A prospective, randomised study is to investigate the feasibility of conducting a superiority randomised controlled trial comparing the application of combined autologous PRP and concentrated autologous bone marrow (PRP-BMA) in addition to standard of care (either reamed intramedullary nailing or fine wire ring external fixator) for patients presenting with fresh tibial diaphyseal fractures.

Inclusion Criteria:

• Aged 18-65, skeletally mature adults.
• Acute unilateral closed tibia diaphyseal fractures as the primary injury.
• Definitive fracture fixation with reamed intramedullary nailing (statically locked) or fine wire ring external fixator to be performed within 14 days from the date of injury.
• Willing and able (in the opinion of the study team) to provide informed consent and participate in all study activities.

Exclusion Criteria:

• Open/compound tibial fracture.
• Fracture Type 42-C2 according to Muller AO classification.
• Multi-segmental nature of this fracture (more than one fracture site within tibia for intervention.)
• Polytrauma (defined as injury severity score of 17 or more.)
• Prior or concomitant illnesses that may affect healing.
• Exposure to drugs that can affect the bone metabolic state within the past three months.
• Receiving chemotherapy, radiation treatment or immunosuppression drugs.
• Currently enrolled in any other study which may impact on the results of the present study.
• If female: pregnancy, breast-feeding, not currently using and not willing to use an effective form of contraception for 12 months post-surgery.