The effect of concentrated bone marrow aspirate in operative treatment of fifth metatarsal stress fractures; a double-blind randomized controlled trial.

Hanneke Weel,Gino M M J Kerkhoffs,Leendert Blankevoort,Wouter H Mallee,J Carel Goslings,Simon Goedegebuure,John G Kennedy,C Niek Van Dijk

doi:10.1186/s12891-015-0649-4

Hanneke Weel, Gino M M J Kerkhoffs + Show 6 more

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https://doi.org/10.1186/s12891-015-0649-4

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Abstract

BackgroundFifth metatarsal (MT-V) stress fractures often exhibit delayed union and are high-risk fractures for non-union. Surgical treatment, currently considered as the gold standard, does not give optimal results, with a mean time to fracture union of 12-18 weeks. In recent studies, the use of bone marrow cells has been introduced to accelerate healing of fractures with union problems. The aim of this randomized trial is to determine if operative treatment of MT-V stress fractures with use of concentrated blood and bone marrow aspirate (cB + cBMA) is more effective than surgery alone. We hypothesize that using cB + cBMA in the operative treatment of MT-V stress fractures will lead to an earlier fracture union.Methods/DesignA prospective, double-blind, randomized controlled trial (RCT) will be conducted in an academic medical center in the Netherlands. Ethics approval is received. 50 patients will be randomized to either operative treatment with cB + cBMA, harvested from the iliac crest, or operative treatment without cB + cBMA but with a sham-treatment of the iliac crest. The fracture fixation is the same in both groups, as is the post-operative care.. Follow up will be one year. The primary outcome measure is time to union in weeks on X-ray. Secondary outcome measures are time to resumption of work and sports, functional outcomes (SF-36, FAOS, FAAM), complication rate, composition of osteoprogenitors in cB + cBMA and cost-effectiveness. Furthermore, a bone biopsy is taken from every stress fracture and analysed histologically to determine the stage of the stress fracture. The difference in primary endpoint between the two groups is analysed using student’s t-test or equivalent.DiscussionThis trial will likely provide level-I evidence on the effectiveness of cB + cBMA in the operative treatment of MT-V stress fractures.Trial registrationNetherlands Trial Register (reg.nr NTR4377)

Highlights

Fifth metatarsal (MT-V) stress fractures often exhibit delayed union and are high-risk fractures for nonunion
Adverse events are defined as any undesirable experience occurring to a patient receiving an investigational medical device that does not necessarily have to have a causal relationship with the device under investigation, e.g. infection, numbness, or paraesthesia
A serious adverse event (SAE) is any undesirable experience associated with the use of the investigational treatment that results in death, is life threatening, requires hospitalization or prolongation of existing inpatients’ hospitalization, or results in persistent or clinically relevant disability or incapacity

Summary

Introduction

Fifth metatarsal (MT-V) stress fractures often exhibit delayed union and are high-risk fractures for nonunion. The use of bone marrow cells has been introduced to accelerate healing of fractures with union problems The aim of this randomized trial is to determine if operative treatment of MT-V stress fractures with use of concentrated blood and bone marrow aspirate (cB + cBMA) is more effective than surgery alone. Soldiers and athletes are prone to fractures due to extensive and repeated stress on (usually weight bearing) bones [1,2,3,4]. These stress fractures develop over time and are different than the more commonly accounted traumatic fractures. The time to return to activity varies from 12 to 18 weeks [9,10,11,12]

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