The Effect of Loss of Offset After Pertrochanteric Fracture Treated With a Intramedullary Nail

Intertrochanteric Fractures Clinical Trial

— PLAIN  

Official title:

The Effect of Loss of Offset After Pertrochanteric Fracture Treated With a Intramedullary Nail

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01344785
• Other study ID #: PLAIN-1
• Status: Completed
• Phase: N/A
• First received: April 28, 2011
• Last updated: October 21, 2013
• Start date: April 2010
• Est. completion date: November 2011

Study information

• Verified date: October 2013
• Source: Danderyd Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Regional Ethical Review Board
• Study type: Observational

Clinical Trial Summary

The purpose of this study is determine the relationship between pain and protrusion of the implant after surgery for a intertrochanteric fracture.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: November 2011
• Est. primary completion date: October 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 55 Years and older

Eligibility

Inclusion Criteria:

• Intertrochanteric Fracture

• Age over 55

• Intramedullary nailing

Exclusion Criteria:

• Severe cognitive impairment

• Substance abuse

Study Design

Observational Model: Cohort, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Fractures, Bone
• Hip Fractures
• Intertrochanteric Fractures

Intervention

Procedure:
• Intramedullary nailing
All patients will be treated with Intramedullary nailing

Locations

Country	Name	City	State
Sweden	Danderyd Hospital	Stockholm

Sponsors (1)

Lead Sponsor	Collaborator
Danderyd Hospital

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hip function		1 year	No