Tibial Fracture - Platelet-rich Plasma and Bone Marrow Concentrate (T-PAC)
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|ClinicalTrials.gov Identifier: NCT03100695|
Recruitment Status : Unknown
Verified March 2017 by PeterGiannoudis, University of Leeds.
Recruitment status was: Not yet recruiting
First Posted : April 4, 2017
Last Update Posted : April 4, 2017
|Condition or disease||Intervention/treatment||Phase|
|Unilateral Tibial Diaphyseal Fracture||Other: Concentrated autologous PRP-BMA||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||45 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||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|
|Estimated Study Start Date :||July 1, 2017|
|Estimated Primary Completion Date :||June 30, 2019|
|Estimated Study Completion Date :||June 30, 2019|
No Intervention: Control
Patients will undergo operative procedure with no additional intervention.
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
Injection of autologous, concentrated platelet-rich plasma and bone marrow aspirate at the site of fixation.
- Time to healing [ Time Frame: 2 weeks, 8 weeks, 12 weeks,16 weeks, 20 weeks, 26 weeks, 29 weeks ]Healing will be assessed both clinically and radiologically (RUST score)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03100695
|Contact: Peter Giannoudis||0113 firstname.lastname@example.org|
|Leeds General Infirmary||Not yet recruiting|
|Leeds, United Kingdom|
|Contact: Bernadette Cook 0113 39222334 email@example.com|