Clinical trial NCT01382485: Reamer Irrigator Aspirator (RIA) vs Autogenous Iliac Crest Bone Graft (AICBG) for the Treatment of Non-unions
Official title: Reamer Irrigator Aspirator Versus Autogenous Iliac Crest Bone Graft for the Treatment of Non-Unions: A Multi-Centre Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Nonunion of Bone Graft
Fractures Non Union
Keywords: non union
bone defect
tibia non union
femur non union
bone graft
Lead sponsor: Unity Health Toronto
Sponsor class: OTHER
First posted: 2011-06-27
Enrollment: 104
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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?

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Subjects male or female, aged 18-65
* Subjects with a nonunion of a long bone requiring bone grafting in the -opinion of their orthopaedic surgeon (nonunion will be defined as "9 months duration of the nonunited fracture with no evidence of progressive healing over the previous 3 months")
* Subjects must have an uninjured, healthy iliac crest and a femur that has not previously been operated on
* Subjects must provide informed consent

Exclusion Criteria:

* Subjects requiring a structural bone graft
* Subjects presenting with an active systemic or local infection
* Subjects with a nonunion due to pathologic fracture
* Patients with severely compromised soft-tissue coverage at the nonunion site, sufficient to impair bone healing
* Patients receiving radiation, chemotherapy, immunosuppression, or chronic steroids
* Subjects with whom there are likely to be problems, in the judgment of the Investigator or Research Coordinator, with maintaining follow-up (such as no fixed address, plans to move out of town in the next year, etc.).

Primary outcomes:
measure: Pain as measured by a Visual Analog Scale (VAS)
timeFrame: 6 weeks post operatively
Secondary outcomes:
measure: Time to union
timeFrame: 1 year
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: St.Michael's Hospital
state: Ontario
Study officials:
affiliation: Unity Health Toronto
name: Aaron Nauth, MD FRCS(C)
role: PRINCIPAL_INVESTIGATOR
References: