Ignite Creation Date:
2024-05-05 @ 5:17 PM
Last Modification Date:
2024-10-26 @ 9:30 AM
Study NCT ID:
NCT00429663
Status:
COMPLETED
Last Update Posted:
2017-05-11
First Post:
2007-01-30
Brief Title:
A Multicenter Randomized Trial Comparing IM Nails and Plate Fixation in Distal Femur Fractures
Sponsor:
Boston Medical Center
Organization:
Boston Medical Center
Study Overview
Official Title:
Study of Locked Plates Versus Intramedullary Nails in Distal Femur Fractures A Multicenter Randomized Trial Comparing IM Nails and Plate Fixation SOLVED
Status:
COMPLETED
Status Verified Date:
2017-04
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:
This study looks at two 2 types of surgical treatments and hopes to answer the question which is the best way to surgically treat a distal femur fracture Both procedures being studied are standard of care used routinely and use FDA approved devices All medical and surgical treatment will be the same for participants as non-participants
Detailed Description:
The study is a randomized controlled multicenter trial in which individuals sustaining a fracture of the supracondylar metaphyseal region of the distal femur will be operatively managed by one of two strategies The first strategy involves fixation of the fracture with a reamed interlocking intramedullary nail Nail Group The second treatment strategy involves open reduction and internal fixation of the fracture with a locking periarticular plate Plate Group The null hypothesis of the study is that there will be no difference in the two groups with respect to the primary and secondary outcome measures To the degree possible patients in the two groups will receive post-operative care according to the same standards and protocols
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