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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):

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

Condition or disease Intervention/treatment
Intertrochanteric Fractures Procedure: Intramedullary nailing

Detailed 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.


Study Design

Study Type : Observational
Actual Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: The Effect of Loss of Offset After Pertrochanteric Fracture Treated With a Intramedullary Nail
Study Start Date : April 2010
Primary Completion Date : October 2011
Study Completion Date : November 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fractures
U.S. FDA Resources

Groups and Cohorts

Group/Cohort Intervention/treatment
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


Outcome Measures

Primary Outcome Measures :
  1. Hip function [ Time Frame: 1 year ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   55 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
100 consecutive patients with an intertrochanteric fracture presenting at the Orthopaedic depertment of Danderyd Hospital, Sweden
Criteria

Inclusion Criteria:

  • Intertrochanteric Fracture
  • Age over 55
  • Intramedullary nailing

Exclusion Criteria:

  • Severe cognitive impairment
  • Substance abuse
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01344785


Locations
Sweden
Danderyd Hospital
Stockholm, Sweden, 18288
Sponsors and Collaborators
Danderyd Hospital
Investigators
Principal Investigator: Max Gordon, MD Danderyd Hospital
More Information

Responsible Party: Olof Skoldenberg, Consultant Orthopaedic surgeon, Danderyd Hospital
ClinicalTrials.gov Identifier: NCT01344785     History of Changes
Other Study ID Numbers: PLAIN-1
First Posted: April 29, 2011    Key Record Dates
Last Update Posted: October 22, 2013
Last Verified: October 2013

Keywords provided by Olof Skoldenberg, Danderyd Hospital:
Intertrochanteric Fractures
Intramedullary nailing
Hip function
Pain

Additional relevant MeSH terms:
Fractures, Bone
Hip Fractures
Wounds and Injuries
Femoral Fractures
Hip Injuries
Leg Injuries