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Tibial Fracture - Platelet-rich Plasma and Bone Marrow Concentrate (T-PAC)

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ClinicalTrials.gov Identifier: NCT03100695
Recruitment Status : Not yet recruiting
First Posted : April 4, 2017
Last Update Posted : April 4, 2017
Sponsor:
Information provided by (Responsible Party):
PeterGiannoudis, 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.

Condition or disease Intervention/treatment Phase
Unilateral Tibial Diaphyseal Fracture Other: Concentrated autologous PRP-BMA Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 45 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fractures

Arm Intervention/treatment
No Intervention: Control
Patients will undergo operative procedure with no additional intervention.
Experimental: Study
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.




Primary Outcome Measures :
  1. 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)



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

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


Contacts
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Contact: Peter Giannoudis 0113 3922750 pgiannoudi@aol.com

Locations
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United Kingdom
Leeds General Infirmary Not yet recruiting
Leeds, United Kingdom
Contact: Bernadette Cook    0113 39222334    bernadette.cook@nhs.net   
Sponsors and Collaborators
University of Leeds

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Responsible Party: PeterGiannoudis, Professor, University of Leeds
ClinicalTrials.gov Identifier: NCT03100695     History of Changes
Other Study ID Numbers: 226136
First Posted: April 4, 2017    Key Record Dates
Last Update Posted: April 4, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Fractures, Bone
Wounds and Injuries