The Effect of Loss of Offset After Pertrochanteric Fracture Treated With a Intramedullary Nail (PLAIN)
Recruitment status was Recruiting
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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 |
| 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 |
100 consecutive patients with an intertrochanteric fracture presenting at the Orthopaedic depertment of Danderyd Hospital, Sweden
Inclusion Criteria:
- Intertrochanteric Fracture
- Age over 55
- Intramedullary nailing
Exclusion Criteria:
- Severe cognitive impairment
- Substance abuse
Contacts and Locations| Contact: Olof Sköldenberg | 4686557245 | olof.skoldenberg@gmail.com |
| Sweden | |
| Danderyd Hospital | Recruiting |
| Stockholm, Sweden, 18288 | |
| Contact: Olof Sköldenberg, MD, PhD olof.skoldenberg@gmail.com | |
| Principal Investigator: Max Gordon, MD | |
| 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