Tibial Fracture - Platelet-rich Plasma and Bone Marrow Concentrate

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Unilateral Tibial Diaphyseal Fracture

Intervention / Treatment
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* Other: Concentrated autologous PRP-BMA


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control<br>Patients will undergo operative procedure with no additional intervention. | |
| Experimental: Study<br>Patients will undergo usual operative procedure with the addition of an injection of autologous, concentrated PRP-BMA at the site of fixation. | Other: Concentrated autologous PRP-BMA<br>* Injection of autologous, concentrated platelet-rich plasma and bone marrow aspirate at the site of fixation.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to healing | Healing will be assessed both clinically and radiologically (RUST score) | 2 weeks, 8 weeks, 12 weeks,16 weeks, 20 weeks, 26 weeks, 39 weeks |