Condition category
Injury, Occupational Diseases, Poisoning
Date applied
29/06/2004
Date assigned
22/07/2004
Last edited
12/11/2007
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

http://www.sprint-trial.com/index.shtml

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

http://www.mcmaster.ca/

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

Publication citations

Additional files

Editorial Notes