Fractures Non Union Clinical Trial
Official title:
Reamer Irrigator Aspirator Versus Autogenous Iliac Crest Bone Graft for the Treatment of Non-Unions: A Multi-Centre Randomized Controlled Trial
The specific question the investigators will seek to answer is: can the Reamer Irrigator Aspirator (RIA) provide a bone graft source for the treatment of nonunions that is equally effective to Autogenous Iliac Crest Bone Graft (AICBG) while resulting in a decreased amount of post-operative pain and a lower rate of complications?
All subjects will be pre-screened by the treating physician. Subjects who present with a
nonunion of a long bone will be invited to speak to the research coordinator regarding the
study. An internet based randomization system will be used to allocate subjects to treatment
groups. Participating sites will be given a unique ID and password to log into the secure
website and register their subject.
Treating physicians will use 1 of 2 bone graft harvesting methods in patients with a nonunion
of a long bone requiring grafting. The first method involves harvesting bone graft from the
iliac crest area. The second method involves using the RIA to harvest bone graft from the
femoral canal. Clinical assessments will occur at the time of hospital admission (baseline),
at post-op day 1, and then at 2 weeks, 6 weeks, 3 months, 6 month, 12 months and 24 months
post-surgery.
Surgical procedure at the nonunion site will not be standardized as this will vary greatly.
Surgeons may use bone graft substitutes at the recipient site at their discretion. We will
however, standardize surgical techniques for harvesting of the graft from the donor site.
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