Ignite Creation Date:
2024-05-05 @ 11:25 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00038129
Status:
COMPLETED
Last Update Posted:
2019-11-01
First Post:
2002-05-29
Brief Title:
SPRINT - Randomized Trial of Tibial Fracture Fixation
Sponsor:
University of Minnesota
Organization:
University of Minnesota
Study Overview
Official Title:
Study to Prospectively Evaluate Reamed Intramedullary Nails in Tibial Shaft Fractures SPRINT
Status:
COMPLETED
Status Verified Date:
2019-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NIAMS-072 | US NIH GrantContract | None | httpsreporternihgovquickSearchR01AR048529 |
| R01AR048529 | NIH | None | None |