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

Sponsor

University of Leeds (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT03100695

Collaborator

(none)

Enrollment

Location

Arms

38.9

Anticipated Duration (Months)

1.2

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Unilateral Tibial Diaphyseal Fracture	Other: Concentrated autologous PRP-BMA	N/A

Study Design

Study Type:

Interventional

Actual 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

Actual Study Start Date :

Oct 4, 2018

Anticipated Primary Completion Date :

Dec 31, 2021

Anticipated Study Completion Date :

Dec 31, 2021

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

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)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Leeds General Infirmary	Leeds		United Kingdom

Sponsors and Collaborators

University of Leeds

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

PeterGiannoudis, Professor, University of Leeds

ClinicalTrials.gov Identifier:

NCT03100695

Other Study ID Numbers:

226136

First Posted:

Apr 4, 2017

Last Update Posted:

Mar 25, 2021

Last Verified:

Mar 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Fractures, Bone

Study Results

No Results Posted as of Mar 25, 2021