PFN-A Augmentation for Intertrochanteric Femoral Fractures

PFN-A Intramedullary Nail and Intertrochanteric Hip Fracture. Augmentation of the Femoral Head Assessed by PET-CT (Positron Emission Tomography - Computed Tomography)- a Randomized Trial

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03000972

Enrollment

Registered

2016-12-22

Start date

2014-01-31

Completion date

2017-10-31

Last updated

2018-05-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Intertrochanteric Fracture

Keywords

Augmentation, PET-CT, Positron Emission Tomography, Fluorine-18

Brief summary

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

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.

Interventions

PROCEDURECement augmentation

PROCEDUREPFN-A Nail

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

65 Years to 80 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Viability of the femoral head as assessed by fluoride uptake using PET-CT	4 months postoperatively	The primary endpoint is the level of fluoride uptake (standardized uptake values: SUVs) representing bone metabolism. PET-CT enables us to quantify this tridimensionally.

Secondary

Measure	Time frame
Viability of the femoral head as assessed by fluoride uptake using PET-CT	Within 1 week postoperatively
Harris Hip Score	4 months

Countries

Sweden

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026