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

NCT ID: NCT01344785

Last Updated: 2013-10-22

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 100 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2010-04-30
• Study Completion Date: 2011-11-30

Brief Summary

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

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.

Conditions

Intertrochanteric Fractures

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

Patients with a intertrochanteric fracture

Patients with a intertrochanteric fracture, n=100

Intramedullary nailing

Intervention Type: PROCEDURE

All patients will be treated with Intramedullary nailing

Interventions

Intramedullary nailing

All patients will be treated with Intramedullary nailing

Intervention Type: PROCEDURE

Other Intervention Names

Gamma 3, Stryker, USA

Eligibility Criteria

Inclusion Criteria

• Intertrochanteric Fracture
• Age over 55
• Intramedullary nailing

Exclusion Criteria

• Severe cognitive impairment
• Substance abuse

• Minimum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Danderyd Hospital

OTHER

Sponsor Role: lead

Responsible Party

Olof Skoldenberg

Consultant Orthopaedic surgeon

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Max Gordon, MD

Role: PRINCIPAL_INVESTIGATOR

Danderyd Hospital

Locations

Danderyd Hospital

Stockholm, , Sweden

Countries

Sweden

Other Identifiers

PLAIN-1

Identifier Type: -

Identifier Source: org_study_id