| May 29, 2002 |
| December 24, 2007 |
| May 2002 |
| November 2006 (final data collection date for primary outcome measure) |
| Necessity for additional operation [ Time Frame: Months 6, 9, and 12 ] [ Designated as safety issue: No ] |
| Necessity for additional operation |
| Complete list of historical versions of study NCT00038129 on ClinicalTrials.gov Archive Site |
| Return to work, functional status, and health-related quality of life [ Time Frame: Months 6, 9, and 12 ] [ Designated as safety issue: No ] |
| Same as current |
| |
| SPRINT - Randomized Trial of Tibial Fracture Fixation |
| Study to Prospectively Evaluate Reamed Intramedullary Nails in Tibial Shaft Fractures (SPRINT) |
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. |
| |
| Interventional |
| Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study |
| Tibial Fracture |
| Procedure: Intramedullary nail implant |
- Experimental: Participants will receive reaming of the intramedullary canal prior to insertion of an intramedullary nail.
- Experimental: Participants will receive insertion of an intramedullary nail without prior reaming of the intramedullary canal.
|
- 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. Epub 2009 Apr 11.
- 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.
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| |
| Completed |
| 1200 |
| November 2006 |
| November 2006 (final data collection date for primary outcome measure) |
Inclusion Criteria:
- Fractured tibia requiring fixation using an intramedullary nail
|
| Both |
| 16 Years and older |
| No |
| Contact information is only displayed when the study is recruiting subjects |
| United States |
| |
| NCT00038129 |
| Mark Swiontkowski, University of Minnesota Twin Cities |
| R01 AR48529, NIAMS-072 |
| National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) |
|
| Study Chair: |
Marc F. Swiontkowski, MD |
Department of Orthopaedic Surgery, University of Minnesota |
|
|
| National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) |
| December 2007 |