Back to resultsReamer Irrigator Aspirator (RIA) vs Autogenous Iliac Crest Bone Graft (AICBG) for the Treatment of Non-unions
Primary Purpose
Nonunion of Bone Graft, Fractures Non Union
Status
Unknown status
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
RIA harvesting group
AICBG harvesting group
Sponsored by
About this trial
This is an interventional treatment trial for Nonunion of Bone Graft focused on measuring non union, bone defect, tibia non union, femur non union, bone graft
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.).
Sites / Locations
- St.Michael's HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
AICBG harvesting group
RIA harvesting group
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
Pain as measured by a Visual Analog Scale (VAS)
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
Secondary outcomes will include time to union,
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01382485
Brief Title
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
2. Study Status
Record Verification Date
November 2019
Overall Recruitment Status
Unknown status
Study Start Date
August 2012 (undefined)
Primary Completion Date
August 2021 (Anticipated)
Study Completion Date
August 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Unity Health Toronto
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nonunion of Bone Graft, Fractures Non Union
Keywords
non union, bone defect, tibia non union, femur non union, bone graft
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
104 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
AICBG harvesting group
Arm Type
Active Comparator
Arm Description
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.
Arm Title
RIA harvesting group
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
RIA harvesting group
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
AICBG harvesting group
Intervention Description
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 Information:
Title
Pain as measured by a Visual Analog Scale (VAS)
Description
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
Time Frame
6 weeks post operatively
Secondary Outcome Measure Information:
Title
Time to union
Description
Secondary outcomes will include time to union,
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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.).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Milena Vicente, RN, CCRP
Phone
416-864-6060
Ext
2608
Email
vicentem@smh.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Aaron Nauth, MD FRCS(C)
Organizational Affiliation
Unity Health Toronto
Official's Role
Principal Investigator
Facility Information:
Facility Name
St.Michael's Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5C 1R6
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Milena Vicente, RN, CCRP
Phone
416-864-6060
Ext
2608
Email
vicentem@smh.ca
First Name & Middle Initial & Last Name & Degree
Aaron Nauth, MD, FRCS(C)
First Name & Middle Initial & Last Name & Degree
Emil Schemitsch, MD, FRCS(C)
First Name & Middle Initial & Last Name & Degree
Michael McKee, MD, FRCS(C)
First Name & Middle Initial & Last Name & Degree
Jeremy Hall, MD,FRCS(C)
12. IPD Sharing Statement
Learn more about this trial
Reamer Irrigator Aspirator (RIA) vs Autogenous Iliac Crest Bone Graft (AICBG) for the Treatment of Non-unions
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