The Effect of Loss of Offset After Pertrochanteric Fracture Treated With a Intramedullary Nail (PLAIN)
The purpose of this study is determine the relationship between pain and protrusion of the implant after surgery for a intertrochanteric fracture.
|Study Design:||Observational Model: Cohort
Time Perspective: Cross-Sectional
|Official Title:||The Effect of Loss of Offset After Pertrochanteric Fracture Treated With a Intramedullary Nail|
- Hip function [ Time Frame: 1 year ] [ Designated as safety issue: No ]
|Study Start Date:||April 2010|
|Study Completion Date:||November 2011|
|Primary Completion Date:||October 2011 (Final data collection date for primary outcome measure)|
Patients with a intertrochanteric fracture
Patients with a intertrochanteric fracture, n=100
Procedure: Intramedullary nailing
All patients will be treated with Intramedullary nailing
Other Name: Gamma 3, Stryker, USA
Intertrochanteric fractures are common fractures in which severe complications such as non-union, implant cut-out and postoperative wound-infections occur at very low rates with modern surgical techniques. While severe complications are rare, the patient reported outcome is less satisfactory with roughly half of the patients complain of thigh pain and others failing to regain their walking ability. The current leading methods for osteosynthesis of intertrochanteric fractures are intramedullary (IM) nails and sliding hip screws (SHS).
Over the period 1998 to 2007 the use of IM nails for pertrochanteric fractures increased from 5% to 20% in Sweden, at the expense of the use of SHS (5). IM nailing has also become more common at our clinic where we since February 2008 use the 3rd generation of the Gamma nail. In this study we investigate if the increased pain after IM nailing, reduced hip function and life quality may correlate to the compression over the fracture and the lateral protrusion of the intramedullary nail.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01344785
|Stockholm, Sweden, 18288|
|Principal Investigator:||Max Gordon, MD||Danderyd Hospital|