Tibial Fracture - Platelet-rich Plasma and Bone Marrow Concentrate
NCT ID: NCT03100695
Last Updated: 2021-03-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
45 participants
INTERVENTIONAL
2018-10-04
2021-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Control
Patients will undergo operative procedure with no additional intervention.
No interventions assigned to this group
Study
Patients will undergo usual operative procedure with the addition of an injection of autologous, concentrated PRP-BMA at the site of fixation.
Concentrated autologous PRP-BMA
Injection of autologous, concentrated platelet-rich plasma and bone marrow aspirate at the site of fixation.
Interventions
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Concentrated autologous PRP-BMA
Injection of autologous, concentrated platelet-rich plasma and bone marrow aspirate at the site of fixation.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
65 Years
ALL
No
Sponsors
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University of Leeds
OTHER
Responsible Party
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PeterGiannoudis
Professor
Locations
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Leeds General Infirmary
Leeds, , United Kingdom
Countries
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Other Identifiers
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226136
Identifier Type: -
Identifier Source: org_study_id
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