PFN-A Augmentation for Intertrochanteric Femoral Fractures

NCT ID: NCT03000972

Last Updated: 2018-05-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-01-31

Study Completion Date

2017-10-31

Brief Summary

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This study evaluates the potential negative effect of cement augmentation in the femoral head on viability of the head. Half of the participants will have the standard intramedullary nail (PFN-A; Proximal Femoral Nail Augmentation), while the other half will get the standard nail plus cement augmentation.

Detailed Description

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Cement augmentation is believed to increase the bone implant interface and therefore decrease the risk of implant cut-out of the femoral head. The cement used in previous studies has produced heat and thermal necrosis on bone cells. The cement used in this study (TraumaCemV+) is manufactured specially for this implant and for the augmentation of this implant. TraumaCemV sets under low temperature (40 degrees Celsius) and we do not anticipate any heat necrosis. The volume effect of the cement could theoretically also damage the blood flow in the femoral head. There have been no negative effects in big series of patients operated with this technique.

The aim of this study is to quantify the viability of the femoral head with the use PET-CT (Positron Emission Tomography with simultaneous Computed Tomography) including a radioactive isotope (Fluorine-18) and the use of threedimensional computed tomography.

Conditions

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Intertrochanteric Fracture

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Standard Nail

Hip fracture surgery with a PFN-A Nail (Proximal Femoral Nail Augmentation).

Group Type ACTIVE_COMPARATOR

PFN-A Nail

Intervention Type PROCEDURE

Augmented Nail

Hip fracture surgery with a PFN-A Nail with Cement augmentation with TraumaCemV+

Group Type EXPERIMENTAL

Cement augmentation

Intervention Type PROCEDURE

PFN-A Nail

Intervention Type PROCEDURE

Interventions

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Cement augmentation

Intervention Type PROCEDURE

PFN-A Nail

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Intertrochanteric Hip Fracture AO (Arbeitsgemeinschaft für Osteosynthesefragen) 31-A1 or AO 31-A2
* Healthy contralateral hip
* ASA (American Society of Anesthesiologists) Physical Status Class I or II

Exclusion Criteria

* Dementia
Minimum Eligible Age

65 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Uppsala University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Olof Wolf, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Uppsala University Hospital

Locations

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Uppsala University Hospital

Uppsala, Uppsala County, Sweden

Site Status

Countries

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Sweden

Other Identifiers

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PFNA

Identifier Type: -

Identifier Source: org_study_id

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