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Completed

NCT Number: NCT01344785

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.

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Key information

Age range

55 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Danderyd Hospital

Stockholm, 18288, Sweden

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Intertrochanteric Fracture
  • Age over 55
  • Intramedullary nailing

Exclusion criteria

  • Severe cognitive impairment
  • Substance abuse

Treatment and study plan

intramedullary nailing

Procedure

All patients will be treated with Intramedullary nailing

Other names: Gamma 3, Stryker, USA

Primary outcomes

  1. Hip function

    Time frame: 1 year

Sponsors and collaborators

Lead sponsor

Danderyd Hospital

Other

Registry information

Acronym: PLAIN

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Apr 29, 2011
Registry last updated
Oct 22, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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