NCT01382485

Reamer Irrigator Aspirator (RIA) vs Autogenous Iliac Crest Bone Graft (AICBG) for the Treatment of Non-unions

Reamer Irrigator Aspirator Versus Autogenous Iliac Crest Bone Graft for the Treatment of Non-Unions: A Multi-Centre Randomized Controlled Trial

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 104 (estimated)
• Sponsor: Unity Health Toronto · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Nonunion of Bone Graft
• Fractures Non Union

Interventions

Type	Name	Description
OTHER	RIA harvesting group	Subjects allocated to the RIA group will have the graft harvested in a standardized fashion using the technique described by Quintero et al. Briefly, the RIA device is a single-pass reamer that is connected to an aspirator and irrigator, allowing simultaneous reaming, irrigation, and aspiration of the contents of the femoral canal. RIA head size and tube length will be chosen based on preoperative templating of anteroposterior and lateral radiographs of the donor femur (a head size of 2mm larger than the inner cortical diameter at the isthmus of the femur will be selected). Fluoroscopic imaging will be used to confirm guidewire positioning and avoid eccentric reaming. Bone graft will be harvested from the central femoral canal and from each femoral condyle in 3 separate passes.
OTHER	AICBG harvesting group	Iliac crest bone graft will be harvested from the anterior iliac crest through an incision beginning 2cm posterior to the anterior superior iliac spine and carried posteriorly. A window will be made in the iliac crest and a curette will subsequently be used to harvest the cancellous bone. The incision will be closed in 3 layers. The infiltration of local anaesthetic will be at the discretion of the surgeon.

Timeline

• Start date: 2012-08-01
• Primary completion: 2021-08-01
• Completion: 2021-08-01
• First posted: 2011-06-27
• Last updated: 2019-11-27

Locations

1 site across 1 country: Canada