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

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

Study Overview

• Status: Completed
• Conditions: Intertrochanteric Fractures
• Intervention / Treatment: 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 Type: Observational
• Enrollment (Actual): 100

Contacts and Locations

Study Locations

• Sweden
  • Stockholm, Sweden, 18288
    • Danderyd Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 55 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

100 consecutive patients with an intertrochanteric fracture presenting at the Orthopaedic depertment of Danderyd Hospital, Sweden

Description

Inclusion Criteria:

• Intertrochanteric Fracture
• Age over 55
• Intramedullary nailing

Exclusion Criteria:

• Severe cognitive impairment
• Substance abuse

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

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 Names: Gamma 3, Stryker, USA

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Hip function	1 year

Collaborators and Investigators

• Sponsor: Danderyd Hospital
• Investigators: Principal Investigator: Max Gordon, MD, Danderyd Hospital

Study record dates

Study Major Dates

• Study Start: April 1, 2010
• Primary Completion (Actual): October 1, 2011
• Study Completion (Actual): November 1, 2011

Study Registration Dates

• First Submitted: April 28, 2011
• First Submitted That Met QC Criteria: April 28, 2011
• First Posted (Estimate): April 29, 2011

Study Record Updates

• Last Update Posted (Estimate): October 22, 2013
• Last Update Submitted That Met QC Criteria: October 21, 2013
• Last Verified: October 1, 2013

More Information

Terms related to this study

• Keywords: Pain; Intertrochanteric Fractures; Intramedullary nailing; Hip function
• Additional Relevant MeSH Terms: Wounds and Injuries; Leg Injuries; Femoral Fractures; Hip Injuries; Fractures, Bone; Hip Fractures
• Other Study ID Numbers: PLAIN-1