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

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ClinicalTrials.gov Identifier: NCT01344785
Recruitment Status : Completed
First Posted : April 29, 2011
Last Update Posted : October 22, 2013
Sponsor:
Information provided by (Responsible Party):
Olof Skoldenberg, Danderyd Hospital

April 28, 2011
April 29, 2011
October 22, 2013
April 2010
October 2011   (Final data collection date for primary outcome measure)
Hip function [ Time Frame: 1 year ]
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Complete list of historical versions of study NCT01344785 on ClinicalTrials.gov Archive Site
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The Effect of Loss of Offset After Pertrochanteric Fracture Treated With a Intramedullary Nail
The Effect of Loss of Offset After Pertrochanteric Fracture Treated With a Intramedullary Nail
The purpose of this study is determine the relationship between pain and protrusion of the implant after surgery for a intertrochanteric fracture.

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.

Observational
Observational Model: Cohort
Time Perspective: Cross-Sectional
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Non-Probability Sample
100 consecutive patients with an intertrochanteric fracture presenting at the Orthopaedic depertment of Danderyd Hospital, Sweden
Intertrochanteric Fractures
Procedure: Intramedullary nailing
All patients will be treated with Intramedullary nailing
Other Name: Gamma 3, Stryker, USA
Patients with a intertrochanteric fracture
Patients with a intertrochanteric fracture, n=100
Intervention: Procedure: Intramedullary nailing
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
100
Same as current
November 2011
October 2011   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Intertrochanteric Fracture
  • Age over 55
  • Intramedullary nailing

Exclusion Criteria:

  • Severe cognitive impairment
  • Substance abuse
Sexes Eligible for Study: All
55 Years and older   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
Sweden
 
 
NCT01344785
PLAIN-1
No
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Olof Skoldenberg, Danderyd Hospital
Danderyd Hospital
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Principal Investigator: Max Gordon, MD Danderyd Hospital
Danderyd Hospital
October 2013