Back to resultsTibial Fracture - Platelet-rich Plasma and Bone Marrow Concentrate (T-PAC)
Primary Purpose
Unilateral Tibial Diaphyseal Fracture
Status
Unknown status
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Concentrated autologous PRP-BMA
Sponsored by
About this trial
This is an interventional treatment trial for Unilateral Tibial Diaphyseal Fracture
Eligibility 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.
Sites / Locations
- Leeds General Infirmary
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Control
Study
Arm Description
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.
Outcomes
Primary Outcome Measures
Time to healing
Healing will be assessed both clinically and radiologically (RUST score)
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03100695
Brief Title
Tibial Fracture - Platelet-rich Plasma and Bone Marrow Concentrate
Acronym
T-PAC
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
Study Type
Interventional
2. Study Status
Record Verification Date
March 2021
Overall Recruitment Status
Unknown status
Study Start Date
October 4, 2018 (Actual)
Primary Completion Date
December 31, 2021 (Anticipated)
Study Completion Date
December 31, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Leeds
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Unilateral Tibial Diaphyseal Fracture
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
45 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control
Arm Type
No Intervention
Arm Description
Patients will undergo operative procedure with no additional intervention.
Arm Title
Study
Arm Type
Experimental
Arm Description
Patients will undergo usual operative procedure with the addition of an injection of autologous, concentrated PRP-BMA at the site of fixation.
Intervention Type
Other
Intervention Name(s)
Concentrated autologous PRP-BMA
Intervention Description
Injection of autologous, concentrated platelet-rich plasma and bone marrow aspirate at the site of fixation.
Primary Outcome Measure Information:
Title
Time to healing
Description
Healing will be assessed both clinically and radiologically (RUST score)
Time Frame
2 weeks, 8 weeks, 12 weeks,16 weeks, 20 weeks, 26 weeks, 39 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Facility Information:
Facility Name
Leeds General Infirmary
City
Leeds
Country
United Kingdom
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Tibial Fracture - Platelet-rich Plasma and Bone Marrow Concentrate
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