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

University of Leeds

Status

Unknown

Conditions

Unilateral Tibial Diaphyseal Fracture

Treatments

Other: Concentrated autologous PRP-BMA

Study type

Interventional

Funder types

Other

Identifiers

NCT03100695

226136

Details and patient eligibility

About

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.

Enrollment

45 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No 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.