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

Purpose

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?

Condition	Intervention
Nonunion of Bone Graft Fractures Non Union	Other: RIA harvesting group Other: AICBG harvesting group

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Bio-equivalence Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Reamer Irrigator Aspirator Versus Autogenous Iliac Crest Bone Graft for the Treatment of Non-Unions: A Multi-Centre Randomized Controlled Trial

Resource links provided by NLM:

MedlinePlus related topics: Bone Grafts Fractures

U.S. FDA Resources

Further study details as provided by St. Michael's Hospital, Toronto:

Primary Outcome Measures:

Pain as measured by a Visual Analog Scale (VAS) [ Time Frame: 6 weeks post operatively ] [ Designated as safety issue: No ]
Our primary outcome will be acute post-operative pain at the donor site, measured by a pain visual analog scale (VAS)at 6 weeks post-operatively

Secondary Outcome Measures:

Time to union [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Secondary outcomes will include time to union,

Estimated Enrollment:	88
Study Start Date:	August 2012
Estimated Study Completion Date:	August 2014
Estimated Primary Completion Date:	August 2014 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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.	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.
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.	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.

Arms

Assigned Interventions

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.

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.

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.

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.

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 and 12 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

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.).

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01382485

Contacts

Contact: Milena Vicente, RN, CCRP

416-864-6060 ext 2608

vicentem@smh.ca

Locations

Canada, Ontario
St.Michael's Hospital	Recruiting
Toronto, Ontario, Canada, M5C 1R6
Contact: Milena Vicente, RN, CCRP 416-864-6060 ext 2608 vicentem@smh.ca
Principal Investigator: Aaron Nauth, MD, FRCS(C)
Principal Investigator: Emil Schemitsch, MD, FRCS(C)
Sub-Investigator: Michael McKee, MD, FRCS(C)
Sub-Investigator: Jeremy Hall, MD,FRCS(C)

Sponsors and Collaborators

St. Michael's Hospital, Toronto

Investigators

Principal Investigator:

Aaron Nauth, MD FRCS(C)

St. Michael's Hospital, Toronto

More Information

No publications provided

Responsible Party:	St. Michael's Hospital, Toronto
ClinicalTrials.gov Identifier:	NCT01382485 History of Changes
Other Study ID Numbers:	RIA2011
Study First Received:	June 22, 2011
Last Updated:	December 10, 2012
Health Authority:	Canada: Health Canada

Keywords provided by St. Michael's Hospital, Toronto:

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

Additional relevant MeSH terms:

Fractures, Ununited
Fractures, Bone
Wounds and Injuries
Anesthetics, Local
Anesthetics
Central Nervous System Depressants

Physiological Effects of Drugs
Pharmacologic Actions
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 22, 2013