Plain English Summary
Not provided at time of registration
Trial website
Contact information
Type
Scientific
Primary contact
Dr Mohit Bhandari
ORCID ID
Contact details
McMaster University
Health Sciences Centre
1200 Main Street West
Hamilton
ON
L8N 3Z5
Canada
+1 905 525 9140 x22825
bhandari@sympatico.ca
Additional identifiers
EudraCT number
ClinicalTrials.gov number
NCT00038129
Protocol/serial number
MCT-38140
Study information
Scientific title
Acronym
SPRINT
Study hypothesis
Our primary objective is to assess the impact of reamed versus non-reamed intramedullary nailing on rates of re-operation (including bone grafts, operation for infection, dynamisation; removal of locking screw(s) due to hardware breakage or loosening of screws, and fasciotomy for intra-operative or post-operative compartment syndrome) in patients with 50% or greater cortical continuity, or less than 1 cm gap between the fracture ends post intramedullary nailing.
Our secondary objective is to assess the impact of reamed and non-reamed intramedullary nailing on functional status, quality of life, and return to normal activities.
Ethics approval
Ethics approval received from the Research Ethics Board of McMaster University, Hamilton, Ontario (Canada) on the 20th April 1999 (ref: # 99-077).
Study design
Multicentre, international, two arm, randomised parallel surgical trial with data analyst blinded.
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
Tibial shaft fractures
Intervention
Reamed Nail Insertion:
Reaming is conducted over the guide wire with cannulated power reamers. The attending surgeon chooses the reamer. To avoid inconsistencies in the degree of reaming, surgeons adhere to the following protocol:
1. Surgeons ream the intramedullary canal until the first detection of "cortical chatter" (i.e. the reamer just begins to contact the cortical bone of the tibia)
2. The size of the nail (diameter) corresponds to the point of "cortical chatter" (if chatter occurs with a 11 mm reamer, then the nail size is 11 mm
3. Following the appearance of "cortical chatter" surgeons ream 1 - 1.5 mm larger than the chosen nails diameter to facilitate its insertion
The chosen nail, which is as long as possible without distracting the fracture by impinging on dense distal metaphyseal bone or protruding above the cortex at the insertion site, is inserted with the appropriate instruments. Distraction of a tibial shaft fracture interferes with healing, so surgeons employ all strategies for achieving cortical contact (up to 10 mm shortening acceptable to achieve contact of fracture ends). The choice of intramedullary nail manufacturer and material (titanium or stainless steel) is at the discretion of the operating surgeon.
Non-Reamed Nail Insertion:
Surgeons insert non-reamed nails across the fracture site ensuring minimal distraction. The goal is to achieve cortical contact of the fracture ends. An upper diameter limit of 10 mm is employed for non-reamed nails. However, in principle the nail should be at least 2 mm less than the diameter at the isthmus of the tibia on anteroposterior and lateral radiographs.
For further information, please contact Dr Bhandari at the address listed below or the principal investigator Dr Gordon Guyatt.
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measures
Impact of reamed and nonreamed intramedullary nailing on:
1. Rates of re-operation
2. Rates of complications
Secondary outcome measures
Functional status using:
1. The Health Utilities Index
2. 36-item Short-Form health survey
3. Tibia Knee Pain Questionnaire
4. The Short Musculoskeletal Functional Assessment
Overall trial start date
01/01/2000
Overall trial end date
30/03/2007
Reason abandoned
Eligibility
Participant inclusion criteria
1. 900 patients of either sex
2. Aged 18 and over
3. With a sustained tibial fracture that requires an operative treatment
4. In 10 Canadian and 13 US centres
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
900
Participant exclusion criteria
1. Fractures not amenable to intramedullary nailing (less than 5 cm distal to the tibial tubercle, or less than 5 cm proximal to the tibiotalar joint)
2. Inability to pass a non-reamed nail
3. Fractures with associated neurovascular deficits (Gustillo Grade IIIC injuries)
4. Pathologic fractures
5. Surgical delay of greater than 12 hours from time of injury (open fractures)
6. Surgical delay of greater than 3 weeks from time of injury (closed fractures)
7. Retained hardware in the affected limb that would interfere with intramedullary nailing
8. Associated fractures of the foot, ankle, or knee
9. Likely problems, in the judgment of the investigators, with maintaining follow-up. For example, we will exclude patients with no fixed address, those who report a plan to move out of town in the next year, or intellectually challenged patients without adequate family support
Recruitment start date
01/01/2000
Recruitment end date
30/03/2007
Locations
Countries of recruitment
Canada, United States of America
Trial participating centre
McMaster University
Hamilton, ON
L8N 3Z5
Canada
Sponsor information
Organisation
McMaster University (Canada)
Sponsor details
Office of the Associate Dean Research
Faculty of Health Sciences
1200 Main St. West
room HSC-3N8
Hamilton
L8N 3Z5
Canada
+1 905 525 9140 ext 22465
hsresadm@mcmaster.ca
Sponsor type
University/education
Website
Funders
Funder type
Research organisation
Funder name
Canadian Institutes of Health Research (CIHR) (Canada) - http://www.cihr-irsc.gc.ca (ref: MCT-38140)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary