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


CONCLUSIONS
This trial will likely provide level-I evidence on the effectiveness of cB + cBMA in the operative treatment of MT-V stress fractures.


BACKGROUND
Netherlands Trial Register (reg.nr NTR4377 ).
Department of Orthopaedic Surgery, Orthopaedic Research Center Amsterdam, Academic Medical Center, Meibergdreef 9, G4-264, 1105, AZ, Amsterdam, The Netherlands. h.weel@amc.nl.
Hanneke
H
Weel
Department of Orthopaedic Surgery, Orthopaedic Research Center Amsterdam, Academic Medical Center, Meibergdreef 9, G4-264, 1105, AZ, Amsterdam, The Netherlands. w.h.mallee@amc.nl.
Wouter H
WH
Mallee
Department of Orthopaedic Surgery, Orthopaedic Research Center Amsterdam, Academic Medical Center, Meibergdreef 9, G4-264, 1105, AZ, Amsterdam, The Netherlands. c.n.vandijk@amc.nl.
C Niek
CN
van Dijk
Department of Orthopaedic Surgery, Orthopaedic Research Center Amsterdam, Academic Medical Center, Meibergdreef 9, G4-264, 1105, AZ, Amsterdam, The Netherlands. l.blankevoort@amc.nl.
Leendert
L
Blankevoort
The Sport Physician Group, Saint Lucas Andreas Hospital department of Sports Medicine, Jan Tooropstraat 164, 1061, AE, Amsterdam, The Netherlands. simongoedegebuure@desportartsengroep.nl.
Simon
S
Goedegebuure
Department of Surgery, Trauma Unit, Academical Medical Center, Meibergdreef 9, 1105, AZ, Amsterdam, The Netherlands. j.c.goslings@amc.nl.
J Carel
JC
Goslings
Orthopaedic Surgery, Hospital for Special Surgery, 523 East 72nd Street, 5th Floor Rm 514, New York, NY, 10021, USA. KennedyJ@hss.edu.
John G
JG
Kennedy
Department of Orthopaedic Surgery, Orthopaedic Research Center Amsterdam, Academic Medical Center, Meibergdreef 9, G4-264, 1105, AZ, Amsterdam, The Netherlands. g.m.kerkhoffs@amc.nl.
Gino M M J
GM
Kerkhoffs
D001706:Biopsy; D016026:Bone Marrow Transplantation / Q000191:economics / Q000379:methods; D001863:Bone Screws; D016025:Bone Transplantation; D003362:Cost-Benefit Analysis; D012090:Cumulative Trauma Disorders / Q000628:therapy; D004311:Double-Blind Method; D005593:Fracture Fixation, Internal / Q000191:economics / Q000379:methods; D017102:Fracture Healing; D017759:Fractures, Malunited / Q000453:epidemiology; D015775:Fractures, Stress / Q000000981:diagnostic imaging / Q000601:surgery / Q000628:therapy*; D006801:Humans; D045164:Mesenchymal Stem Cell Transplantation / Q000191:economics / Q000379:methods; D008682:Metatarsal Bones / Q000000981:diagnostic imaging / Q000293:injuries* / Q000473:pathology / Q000601:surgery; D018579:Patient Selection; D011183:Postoperative Complications / Q000453:epidemiology; D011446:Prospective Studies; D011859:Radiography; D020127:Recovery of Function; D012107:Research Design