Clinical trial NCT00038129: SPRINT - Randomized Trial of Tibial Fracture Fixation
Official title: Study to Prospectively Evaluate Reamed Intramedullary Nails in Tibial Shaft Fractures (SPRINT)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tibial Fracture
Lead sponsor: University of Minnesota
Sponsor class: OTHER
Collaborators: name: National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
First posted: 2002-05-30
Enrollment: 1200
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine if there is a difference in the rate of healing of a tibia fracture treated with an intramedullary nail based on whether or not the bone was reamed prior to nail insertion.

Detailed description: Patients with tibia fractures that are amenable to being treated with both a reamed and an unreamed nail will be randomized via telephone to one of the two groups. These patients then will be followed for a year with clinical, as well as subjective, outcome follow-up questionnaires. Time to healing, as well as repeat interventions and adverse events, will be tracked. The rationale for doing a large sample size multi-center trial is the hope that a clear answer to whether or not one of these two methods is significantly better than the other will become apparent and thus aid surgeons in making a more informed operative treatment choice.

Eligibility criteria: Inclusion Criteria:

* Fractured tibia requiring fixation using an intramedullary nail

Primary outcomes:
measure: Necessity for additional operation
timeFrame: Months 6, 9, and 12
Secondary outcomes:
measure: Return to work, functional status, and health-related quality of life
timeFrame: Months 6, 9, and 12
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: San Francisco General Hospital
state: California
city: Jacksonville
country: United States
facility: University of Florida - Jacksonville
state: Florida
city: Evansville
country: United States
facility: Deaconess Hospital
state: Indiana
city: Louisville
country: United States
facility: University of Louisville
state: Kentucky
city: Boston
country: United States
facility: Boston Medical Center
state: Massachusetts
city: Detroit
country: United States
facility: Detroit Receiving Hospital
state: Michigan
city: Saint Paul
country: United States
facility: Regions Hospital
state: Minnesota
city: Buffalo
country: United States
facility: University of Buffalo
state: New York
city: Jamaica
country: United States
facility: Jamaica Hospital
state: New York
city: Raleigh
country: United States
facility: Wake Medical Center
state: North Carolina
city: Winston-Salem
country: United States
facility: Wake Forest Medical Center
state: North Carolina
city: Cleveland
country: United States
facility: Metrohealth Medical Center
state: Ohio
city: Oklahoma City
country: United States
facility: University of Oklahoma
state: Oklahoma
city: Portland
country: United States
facility: Oregon Health & Science Univesity
state: Oregon
city: Nashville
country: United States
facility: Vanderbilt University
state: Tennessee
city: Houston
country: United States
facility: Memorial Hermann Hospital
state: Texas
Study officials:
affiliation: Department of Orthopaedic Surgery, University of Minnesota
name: Marc F. Swiontkowski, MD
role: STUDY_CHAIR
References:
citation: Swiontkowski M, Teague D, Sprague S, Bzovsky S, Heels-Ansdell D, Bhandari M, Schemitsch EH, Sanders DW, Tornetta P, Walter SD; SPRINT Investigators. Impact of centre volume, surgeon volume, surgeon experience and geographic location on reoperation after intramedullary nailing of tibial shaft fractures. Can J Surg. 2021 Jul 5;64(4):E371-E376. doi: 10.1503/cjs.004020.
citation: Khan JS, Devereaux PJ, LeManach Y, Busse JW. Patient coping and expectations about recovery predict the development of chronic post-surgical pain after traumatic tibial fracture repair. Br J Anaesth. 2016 Sep;117(3):365-70. doi: 10.1093/bja/aew225.
citation: Busse JW, Bhandari M, Guyatt GH, Heels-Ansdell D, Kulkarni AV, Mandel S, Sanders D, Schemitsch E, Swiontkowski M, Tornetta P 3rd, Wai E, Walter SD; SPRINT Investigators & the Medically Unexplained Syndromes Study Group. Development and validation of an instrument to predict functional recovery in tibial fracture patients: the Somatic Pre-Occupation and Coping (SPOC) questionnaire. J Orthop Trauma. 2012 Jun;26(6):370-8. doi: 10.1097/BOT.0b013e31822421e2.
citation: SPRINT Investigators; Briel M, Sprague S, Heels-Ansdell D, Guyatt G, Bhandari M, Blackhouse G, Sanders D, Schemitsch E, Swiontkowski M, Tornetta P 3rd, Walter SD, Goeree R. Economic evaluation of reamed versus unreamed intramedullary nailing in patients with closed and open tibial fractures: results from the study to prospectively evaluate reamed intramedullary nails in patients with tibial fractures (SPRINT). Value Health. 2011 Jun;14(4):450-7. doi: 10.1016/j.jval.2010.10.034. Epub 2011 May 25.
citation: Busse JW, Bhandari M, Guyatt GH, Heels-Ansdell D, Mandel S, Sanders D, Schemitsch E, Swiontkowski M, Tornetta P 3rd, Wai E, Walter SD; SPRINT Investigators. Use of both Short Musculoskeletal Function Assessment questionnaire and Short Form-36 among tibial-fracture patients was redundant. J Clin Epidemiol. 2009 Nov;62(11):1210-7. doi: 10.1016/j.jclinepi.2009.01.014. Epub 2009 Apr 11.
citation: SPRINT Investigators; Bhandari M, Guyatt G, Tornetta P 3rd, Schemitsch E, Swiontkowski M, Sanders D, Walter SD. Study to prospectively evaluate reamed intramedually nails in patients with tibial fractures (S.P.R.I.N.T.): study rationale and design. BMC Musculoskelet Disord. 2008 Jun 23;9:91. doi: 10.1186/1471-2474-9-91.