Tibial Fracture - Platelet-rich Plasma and Bone Marrow Concentrate (T-PAC)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03100695|
Recruitment Status : 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|