Tibial Fracture - Platelet-rich Plasma and Bone Marrow Concentrate
Not Applicable
- Conditions
- Unilateral Tibial Diaphyseal Fracture
- Interventions
- Other: Concentrated autologous PRP-BMA
- Registration Number
- NCT03100695
- Lead Sponsor
- University of Leeds
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 45
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Study Concentrated autologous PRP-BMA Patients will undergo usual operative procedure with the addition of an injection of autologous, concentrated PRP-BMA at the site of fixation.
- Primary Outcome Measures
Name Time Method Time to healing 2 weeks, 8 weeks, 12 weeks,16 weeks, 20 weeks, 26 weeks, 39 weeks Healing will be assessed both clinically and radiologically (RUST score)
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Leeds General Infirmary
🇬🇧Leeds, United Kingdom