Tibial Fracture - Platelet-rich Plasma and Bone Marrow Concentrate

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

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03100695

Acronym

T-PAC

Enrollment

Registered

2017-04-04

Start date

2018-10-04

Completion date

2021-12-31

Last updated

2021-03-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Unilateral Tibial Diaphyseal Fracture

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.

Interventions

OTHERConcentrated autologous PRP-BMA

Injection of autologous, concentrated platelet-rich plasma and bone marrow aspirate at the site of fixation.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

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.

Design outcomes

Primary

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

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026