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| ID | Type | Description | Link |
|---|---|---|---|
| R01AR048529 | U.S. NIH Grant/Contract | View source | |
| NIAMS-072 |
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| Name | Class |
|---|---|
| National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Participants will receive reaming of the intramedullary canal prior to insertion of an intramedullary nail. |
|
| 2 | Experimental | Participants will receive insertion of an intramedullary nail without prior reaming of the intramedullary canal. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intramedullary nail implant | Procedure | Insertion of an intramedullary nail during tibial fracture fixation with or without prior reaming of the intramedullary canal. |
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| Measure | Description | Time Frame |
|---|---|---|
| Necessity for additional operation | Months 6, 9, and 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Return to work, functional status, and health-related quality of life | Months 6, 9, and 12 |
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Inclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Marc F. Swiontkowski, MD | Department of Orthopaedic Surgery, University of Minnesota | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| San Francisco General Hospital | San Francisco | California | 94110 | United States | ||
| University of Florida - Jacksonville |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37442585 | Derived | Schemitsch EH, Kumar A, Heels-Ansdell D, Sprague S, Bhandari M, Guyatt G, Sanders DW, Swiontkowski M, Tornetta P 3rd, Walter S; SPRINT Investigators. Reamed compared with unreamed nailing of tibial shaft fractures: Does the initial method of nail insertion influence outcome in patients requiring reoperations? Can J Surg. 2023 Jul 13;66(4):E384-E389. doi: 10.1503/cjs.012222. Print 2023 Jul-Aug. | |
| 34222771 | Derived | 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. |
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| Jacksonville |
| Florida |
| 32209 |
| United States |
| Deaconess Hospital | Evansville | Indiana | 47710 | United States |
| University of Louisville | Louisville | Kentucky | 40202 | United States |
| Boston Medical Center | Boston | Massachusetts | 02118 | United States |
| Detroit Receiving Hospital | Detroit | Michigan | 48201 | United States |
| Regions Hospital | Saint Paul | Minnesota | 55101 | United States |
| University of Buffalo | Buffalo | New York | 14215 | United States |
| Jamaica Hospital | Jamaica | New York | 11418 | United States |
| Wake Medical Center | Raleigh | North Carolina | 27610 | United States |
| Wake Forest Medical Center | Winston-Salem | North Carolina | 27157 | United States |
| Metrohealth Medical Center | Cleveland | Ohio | 44109 | United States |
| University of Oklahoma | Oklahoma City | Oklahoma | 73190 | United States |
| Oregon Health & Science Univesity | Portland | Oregon | 97201 | United States |
| Vanderbilt University | Nashville | Tennessee | 37232 | United States |
| Memorial Hermann Hospital | Houston | Texas | 77030 | United States |
| 27543531 | Derived | 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. |
| 22011635 | Derived | 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. |
| 21669369 | Derived | 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. |
| 19364637 | Derived | 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. |
| 18573205 | Derived | 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. |
| ID | Term |
|---|---|
| D013978 | Tibial Fractures |
| ID | Term |
|---|---|
| D050723 | Fractures, Bone |
| D014947 | Wounds and Injuries |
| D007869 | Leg Injuries |
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| ID | Term |
|---|---|
| D005594 | Fracture Fixation, Intramedullary |
| ID | Term |
|---|---|
| D005593 | Fracture Fixation, Internal |
| D005592 | Fracture Fixation |
| D019637 | Orthopedic Procedures |
| D013812 | Therapeutics |
| D013514 | Surgical Procedures, Operative |
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