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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2011 by Danderyd Hospital.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Danderyd Hospital
ClinicalTrials.gov Identifier:
NCT01344785
First received: April 28, 2011
Last updated: NA
Last verified: April 2011
History: No changes posted
  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:

Estimated Enrollment: 100
Study Start Date: April 2010
Estimated Study Completion Date: November 2011
Estimated 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01344785

Contacts
Contact: Olof Sköldenberg 4686557245 olof.skoldenberg@gmail.com

Locations
Sweden
Danderyd Hospital Recruiting
Stockholm, Sweden, 18288
Contact: Olof Sköldenberg, MD, PhD         olof.skoldenberg@gmail.com    
Principal Investigator: Max Gordon, MD            
Sponsors and Collaborators
Danderyd Hospital
Investigators
Principal Investigator: Max Gordon, MD Danderyd Hospital
  More Information

No publications provided

Responsible Party: Max Gordon, Danderyd Hospital
ClinicalTrials.gov Identifier: NCT01344785     History of Changes
Other Study ID Numbers: PLAIN-1
Study First Received: April 28, 2011
Last Updated: April 28, 2011
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 June 17, 2013