Recruiting

RIA vs. AICBG

Sponsor:

Unity Health Toronto

Code:

NCT01382485

Conditions

Nonunion of Bone Graft

Fractures Non Union

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Interventions

RIA harvesting group

AICBG harvesting group

Study Details

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?

Conditions

Nonunion of Bone Graft

Fractures Non Union

Study ID

NCT01382485

Start date

Aug, 2012

Status verified date

Nov, 2019

Completion date

Aug, 2021

Anticipated

Primary completion date

Aug, 2021

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

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.).

Study Design

Enrollment

104 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: 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.

experimental: 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.

Interventions

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.

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.

Primary outcome measure

  • Pain as measured by a Visual Analog Scale (VAS) [ Time Frame: 6 weeks post operatively ]

Central Contacts and Locations

Central contacts

Milena Vicente, RN, CCRP

416-864-6060vicentem@smh.ca

Locations

St.Michael's Hospital

Recruiting

Toronto, Ontario, Canada, M5C 1R6

Contacts

Milena Vicente, RN, CCRP

416-864-6060vicentem@smh.ca

Principal Investigator:

Aaron Nauth, MD, FRCS(C)

More Information

Sponsor

Unity Health Toronto

Last update posted

Nov 27, 2019

Last verified

Nov, 2019

Keywords

  • non union
  • bone defect
  • tibia non union
  • femur non union
  • bone graft

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Unity Health Toronto on 2019-11-27.