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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Olof Skoldenberg, Danderyd Hospital
ClinicalTrials.gov Identifier:
NCT01344785
First received: April 28, 2011
Last updated: October 21, 2013
Last verified: October 2013
  Purpose

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


Condition Intervention
Intertrochanteric Fractures
Procedure: Intramedullary nailing

Study Type: Observational
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

Resource links provided by NLM:


Further study details as provided by Danderyd Hospital:

Primary Outcome Measures:
  • Hip function [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Enrollment: 100
Study Start Date: April 2010
Study Completion Date: November 2011
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   55 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01344785

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

No publications provided

Responsible Party: Olof Skoldenberg, Consultant Orthopaedic surgeon, Danderyd Hospital
ClinicalTrials.gov Identifier: NCT01344785     History of Changes
Other Study ID Numbers: PLAIN-1
Study First Received: April 28, 2011
Last Updated: October 21, 2013
Health Authority: Sweden: Regional Ethical Review Board

Keywords provided by 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

ClinicalTrials.gov processed this record on July 23, 2014