T-PAC
Research type
Research Study
Full 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.
IRAS ID
226136
Contact name
Peter Giannoudis
Contact email
Sponsor organisation
University of Leeds
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 11 months, 30 days
Research summary
This is a randomised controlled feasibility study to investigate the practicalities of conducting a full randomised controlled trial of the use of autologous platelet-rich plasma and concentrated bone marrow (PRP-BMA) in the treatment of tibial fracture. PRP-BMA involves taking a small amount of peripheral blood and bone marrow from the patient during surgery and using a point-of-care device to concentrate the cells, which are then injected at the site of fixation. Currently this treatment is used to treat fractures that fail to heal (non union fractures), but there is some evidence to suggest that if used in all patients at the point of fixation it could improve healing and reduce the rate of non union. Our feasibility study will provide important information which will aid in the design of a full trial, including the willingness of patients to be randomised, the practicalities of recruitment, randomisation and blinding, the logistics of treatment in the theatre setting and the outcomes measures to be used. It will also provide a preliminary indication of clinical efficacy and safety, and will explore the relationship between the number of cells injected and the clinical outcomes for the patient. We will recruit 45 patients presenting at the LGI trauma clinic with tibial fractures, with 30 being randomised to receive the cells and 15 randomised to the control group. Patients will be blinded to their treatment, and to maintain blinding control arm patients will have a small incision made at the site on bone marrow harvest (although no tissue will be taken). Patients will be followed up for a total of 39 weeks, or until their fracture is clinically healed if this is earlier than 39 weeks. Healing will be measured clinically and radiologically, and patient reported outcomes (pain and function) will also be collected.
REC name
Yorkshire & The Humber - Leeds West Research Ethics Committee
REC reference
17/YH/0209
Date of REC Opinion
25 Aug 2017
REC opinion
Further Information Favourable Opinion