Randomised trial of reamed versus non-reamed nails in tibial fractures

ISRCTN	ISRCTN88015476
DOI	https://doi.org/10.1186/ISRCTN88015476
ClinicalTrials.gov number	NCT00038129
Secondary identifying numbers	MCT-38140

Submission date: 29/06/2004
Registration date: 22/07/2004
Last edited: 30/01/2019

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Injury, Occupational Diseases, Poisoning

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Study website

Contact information

Dr Mohit Bhandari
Scientific

McMaster University
Health Sciences Centre
1200 Main Street West
Hamilton, ON
L8N 3Z5
Canada

Phone	+1 905 525 9140 x22825
Email	bhandari@sympatico.ca

Study information

Study design	Multicentre, international, two arm, randomised parallel surgical trial with data analyst blinded.
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Scientific title	Randomised trial of reamed versus non-reamed nails in tibial fractures
Study acronym	SPRINT
Study objectives	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(s)	Ethics approval received from the Research Ethics Board of McMaster University, Hamilton, Ontario (Canada) on the 20th April 1999 (ref: # 99-077).
Health condition(s) or problem(s) studied	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
Primary outcome measure	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 study start date	01/01/2000
Completion date	30/03/2007

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Both
Target number of participants	900
Key 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
Key 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
Date of first enrolment	01/01/2000
Date of final enrolment	30/03/2007

Locations

Countries of recruitment

Canada
United States of America

Study participating centre

McMaster University

Hamilton, ON
L8N 3Z5
Canada

Sponsor information

McMaster University (Canada)
University/education

Office of the Associate Dean Research
Faculty of Health Sciences
1200 Main St. West, room HSC-3N8
Hamilton
L8N 3Z5
Canada

Phone	+1 905 525 9140 ext 22465
Email	hsresadm@mcmaster.ca
Website	http://www.mcmaster.ca/
"ROR"	https://ror.org/02fa3aq29

Funders

Funder type

Research organisation

Canadian Institutes of Health Research (CIHR) (Canada) - http://www.cihr-irsc.gc.ca (ref: MCT-38140)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Protocol article	protocol	23/06/2008	30/01/2019	Yes	No
Results article	results	01/06/2012	30/01/2019	Yes	No
Results article	results	01/11/2009	30/01/2019	Yes	No
Results article	results	01/06/2011	30/01/2019	Yes	No
Results article	results	01/09/2016	30/01/2019	Yes	No

Editorial Notes

30/01/2019: Publication reference added