Tibial Fracture - Platelet-rich Plasma and Bone Marrow Concentrate

Unilateral Tibial Diaphyseal Fracture Clinical Trial

— 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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03100695
• Other study ID #: 226136
• Status: Active, not recruiting
• Phase: N/A
• Start date: October 4, 2018
• Est. completion date: December 31, 2021

Study information

• Verified date: March 2021
• Source: University of Leeds
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 45
• Est. completion date: December 31, 2021
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Fractures, Bone
• Unilateral Tibial Diaphyseal Fracture

Intervention

Other:
• Concentrated autologous PRP-BMA
Injection of autologous, concentrated platelet-rich plasma and bone marrow aspirate at the site of fixation.

Locations

Country	Name	City	State
United Kingdom	Leeds General Infirmary	Leeds

Sponsors (1)

Lead Sponsor	Collaborator
University of Leeds

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to healing	Healing will be assessed both clinically and radiologically (RUST score)	2 weeks, 8 weeks, 12 weeks,16 weeks, 20 weeks, 26 weeks, 39 weeks